Quality Systems Resume Samples

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A Bailey

Adolfo

Bailey

636 Beaulah Square

Boston

+1 (555) 570 7811

636 Beaulah Square

Boston

Phone

p +1 (555) 570 7811

Experience Experience

Phoenix, AZ

Quality Systems Supervisor

Phoenix, AZ

Shanahan LLC

Phoenix, AZ

Quality Systems Supervisor

Execute performance and career development discussions
Acts as Distribution Quality contact and work with Distribution on Quality concerns/initiatives. Also, assists with product disposition and security items
Develop, set, and achieve goals associated with quality system improvements which align to Jackson Plant/Quality Department goals and objectives
Participate in the QRMP audit and assist with the development of procedures and follow up on corrective actions as assigned
Provides support in the development, implementation and maintenance of quality systems
Report to and assist the Quality Manager in the enhancement and maintenance of Quality Systems and site adherence of those systems
Manage quality systems team to provide quality support to various levels of manufacturing personnel and business groups

Detroit, MI

Quality Systems Coordinator

Detroit, MI

Keebler LLC

Detroit, MI

Quality Systems Coordinator

Assist in the management of the company’s audit programme, including the planning and organising of internal audits
Assist with the development and administration of an internal cross audit system with volunteer auditors
Recommend organizational process improvement initiatives based on identified trends and key performance quality metrics
Perform analysis and report on trend data. Report and escalate system and process performance metrics to the Business Process Owners (BPOs)
Assist in the update and maintenance of the company management system
Lead the continuous improvement process of Quality and Environmental Management systems to ensure effective, lean processes
Collect, organize, monitor, and communicate information and reports related to the Management System and process improvements

present

Chicago, IL

Senior Specialist, Quality Systems

Chicago, IL

Zulauf-Hyatt

present

Chicago, IL

Senior Specialist, Quality Systems

present

Coordination and communication between multiple departments, including Manufacturing, Process Science, Quality and other functional areas
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations, Supply Chain
Partners with HR team to coordinate and deliver New Hire training
Act as the primary liaison for the AH Quality Operations LOB Leader in assisting sites in complex compliance issues such as significant investigations
Co-ordinate a timely and effective internal escalation / external reporting processes for quality defects
Highly regulated (FDA, DEA, EMEA, and EPA). Significant technical/operational risk due to increasing legal and regulatory complexity
Key User/Point of Contact for Quality Systems. Provides process and system training for site staff involved with the Quality System process

Education Education

Bachelor’s Degree in Quality Engineering

Washington State University

Bachelor’s Degree in Quality Engineering

Skills Skills

Strong verbal and written communication skills, ability to influence behavior through positive dialogue and have strong quantitative and analytical skills
Ability to work with limited supervision, multi-task, and possesses attention to detail
Basic knowledge of 21 CFR Part 11 compliance is
Knowledge of Good Manufacturing Practices (GMP’s), SQF and HACCP/HARPC
Ability to interpret a variety of technical information in mathematical and/or narrative form and deal with several abstract and concrete variables
Working knowledge of ISO:9001
Excellent communication skills
AS in Technical or Business and 1 year experience as a Lead auditor with process and quality audits and/or administrative skills or 5 – 10 years of equivalent experience
Ability to think ahead and plan over an extended time period and prepare action plans to achieve results
Knowledge of aseptic (laboratory) methods, measures, and practices

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Quality Systems Project Manager Resume Examples & Samples

8+ years in a Project Management position with at least 3 years in a pharmaceutical environment or equivalent exposure
Knowledge of technical and administrative aspects of all phases of project management, including management of quality systems used to manufacture capsules and tablets, all related cGMP guidelines and FDA/DEA regulations
Able to facilitate and communicate in a multidisciplinary environment; with extensive experience in the generic pharmaceutical industry
Knowledge of both theoretical and practical aspects of project management, techniques and tools
Experience in strategic planning and risk management

Quality Systems Lab Manager Resume Examples & Samples

5+ years of experience overseeing and managing QA activities in a hospital laboratory environment
Bachelor of Science
Excellent organization and communication skills
Strong ability to set and meet professional goals

Quality Systems & Compliance Manager Resume Examples & Samples

10+ years of experience within a quality organization including working with supplier quality functions (minimum 4 years in the Medical Device or Pharmaceutical industry is required)
Bachelor's Degree in an Engineering discipline (Mechanical, Biomedics, materials, Industrial, etc) or related technical field (microbiology, chemistry, etc.)
Demonstrated expertise in Implementing and maintaining quality systems with emphasis in Supplier management controls
Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive) and Canadian Medical Devices Regulations
Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
ASQ Certification (such as CQA, CQE, CMQ/QE)

Quality Systems Associate Resume Examples & Samples

LIMS, EXCEL and Biopharma experience are mandatory
Experience in templating in LIMS (Sample Manager preferable) required
Highly skilled in Microsoft applications such as Excel, Word, and Powerpoint
Ability to work in a fast paced environment and adjust to changing priorities
Experience in the biotech or pharma required

Lead Auditor Quality Systems Coordinator Resume Examples & Samples

Develop, improve, implement and maintain procedures and systems compliant with TS16949 and Ford specific requirements
Plan and facilitate registration and surveillance audits with external auditors. Represent MSS to auditors and sustain TS 16949, Ford specific Q1, MSA CQI certifications
Conduct Ford specific MSA (manufacturing site assessment). Develop, improve and maintain systems to ensure compliance
Develop and execute internal audit schedule. Train, develop internal auditors
Develop and maintain Layered Process Audit system and standardize work audit system. Track and facilitate issue closure and measure effectiveness
Develop and maintain Poke Yoke and red rabbit system. Track and facilitate issue closure and measure effectiveness
Conduct quality systems orientation to new hires/ refresher training to existing employees
Maintain monthly KOI for internal audit and LPA and report to senior management
Maintain document and data control process for the facility. Upkeep ETQ
Lead, monitor and facilitate systemic issue closure. Utilizing mechanisms such as ETQ CARs, Issue list. 8D, 6 panel
Support, Lead systems improvement
Develop improve and maintain Hold cage, Conduct daily scrap review meetings and ensure timely disposition
Provide issue resolution and customer liaison support for service issues
Comply with legislative requirements as it pertains to OHSA (Occupational Health & Safety Act) and WSIA (Workplace Safety and Insurance Act)
Lead TS auditor certification
AIAG core tools (PPAP, MSA, PFMEA, APQP, Control Plan, SPC) training certification
ASQ internal auditor / CQA/ CQE certification is and asset
Requires basic knowledge of developed standards and methods. Conducts basic analysis. May be required to prioritize tasks
Explains, persuades and negotiates to gain cooperation and acceptance of ideas or proposed actions

Customer Service Quality Systems & Documentation Specialist Resume Examples & Samples

5+ yrs experience working in a cGMP environment
Experience conducting investigations
Working knowledge of logistics and distribution
Experience with temperature sensitive logistics
Proficient in writing and compiling concise documentation
Experience working with TrackWise preferred
Previous technical writing experience preferred

Senior Mgr-quality Systems Resume Examples & Samples

EnsureknowledgeandpracticeoftheGroup’sQualitySystemsandProcedureswithinthePlant.In support of the quality system, provide effective leadership support, training and guidance to all company
BA/BS undergraduate degree in life sciences, engineering or business. Advanced Degree desired
10+ years quality and regulatory experience. Advanced knowledge of ISO9001 or equivalent required
5+ years electronics or consumer device manufacturing experience desired

Quality Systems Director Resume Examples & Samples

Certification in Quality Assurance
5 years' experience in a quality assurance program
Ability to delegate responsibilities
Detail-oriented and collaborative

Quality Systems Technician Resume Examples & Samples

Creates process audit plans and schedules. Audits processes, documentation, and/or individuals to established standards and documents findings for management review
Coordinates and performs investigations and documents findings. Notifies appropriate personnel of stop shipments to contain possible defective products
Coordinates, follows, reviews and maintains established test plan
Monitors, tracks, and follows up on corrective action items as necessary. Creates and maintains action tracker list
Issues Problem Investigation Report (PIR) and ensures closure is achieved
Writes, modifies and maintains quality documents for management approval. Creates and maintains work instructions, files, logs, databases, and reports
Performs media feed, image and physical properties evaluation tests following quality specifications. Performs tests in varying environmental conditions for compatibility, product investigation, and final evaluation. Recommends or rejects test media based on test results data and history of the media
Performs investigations of media type or equipment issues, documents findings, and makes recommendation for improvement activities. Trains personnel in existing testing practices and procedures to ensure consistency and compliance to established testing standards

Senior Quality Systems Documentation Specialist Resume Examples & Samples

B.S. in scientific discipline or equivalent
Requires a minimum of 2 years previous experience in document management working in a cGMP/GXP environment. Experience in Document Management
Has knowledge of practical applications of Document Management and cGMP
Proficiency with MS Office, including Word, Excel and Power Point, Adobe and ability to learn new systems
Experience with Quality System Software particularly electronic documentation management preferred
Excellent interpersonal and professional skills
Contributes to the completion of organizational projects and goals
Sound communication skills and customer focus with ability to interact in a global, cross functional organization
Comply with company and departmental procedural guidelines, SOPs and safety procedures
Demonstrate problem-solving skills, solution focused and ability to make decisions including escalation
Capable of sound decision making, including escalation,
Effectively embrace change, and be an agent for change in the department and company
Demonstrated ability to work independently and in a team environment, take initiative complete tasks to deadlines
Must be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands

Quality Systems Lead-deviation BPO Resume Examples & Samples

Minimum requirements include a Bachelor's degree in a technical discipline (engineering or biological sciences)
Minimum of 8 years pharmaceutical and/or biopharmaceutical industry experience Experience with change control, deviation and CAPA systems
TrackWise experience
Interactions with Boards of Health Inspectors
Data Analytics
Ability to work in, and be adaptable to, a diverse, dynamic, and team-oriented environment
Ability to lead projects and initiatives
Ability to work independently and make compliance related decisions
Ability to solve problems and analyze data
Work under challenging deadlines and be accountable for completing work within specified time periods. Execute tasks in a timely manner without direct supervision
Ability to effectively work and achieve results in a matrix organization
Ability to analyze process flows, identifies gaps and bottlenecks, and implements effective corrective actions to increase efficiency and/or improve compliance
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
Ability to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results
Ability to establish well thought out strategies for integrations of processes and develop project plans from those strategies
Comfortable with public speaking to provide classroom based training requirements and on the job training
Comfortable interacting with Board of Health Inspectors

Quality Systems Integration Data Consultant Resume Examples & Samples

Work collaboratively within a team set on driving Population Health measurement and improvement
Consult with associates in other business areas, identifying business requirements and translating those requirements into system specifications
Act as a subject matter lead for specific data types, providing accurate and timely analysis, testing and documentation of complex systems tasks
Design, guide and oversee the development and implementation of processes to improve data quality within lab data areas
Develop and maintain key relationships with all impacted business areas, such as external labs, information technology, and internal stakeholders
Review and analyze lab data and results, assisting other business areas with issue resolution
Create and lead initiatives for special projects, developing a greater understanding of system and environmental issues in the process
Experience interpreting and leveraging data in effective decision making
Technology software experience with: SQL, MS Access, Excel
Demonstrated ability to effectively manage all tactical aspects of an initiative
Experience managing medium to large scale projects/initiatives in a fast paced environment
Excellent communication skills due to high exposure across Humana and external networks
Technology software experience with: Oracle PL/SQL
HEDIS knowledge
Experience with data visualization tools such as Tableau and QlikView
Ability to understand complex systems
Data mining experience

Quality Systems Program Manager Resume Examples & Samples

6-8 years of experience in Quality Compliance/Quality Systems
4-year degree
Ability to work within a team environment and build relationships outside of the department as well as outside the company
Proven ability to direct, build, develop a team of professionals
Excellent Communication skills and ability to work with employees at all levels of the organization
Proficient computer skills platforms and applications

Quality Systems Technician Resume Examples & Samples

Develops test plans/matrix based on approval requirement and management review
Leads audits and discusses audit results with proper personnel for future quality assurance planning
Makes recommendations for countermeasures to prevent future quality issues
Monitors and tracks quality and/or manufacturing data. Organizes data and recommends changes for process improvement
Supports quality meetings by supplying investigation information. Prepares summary of investigation and presents findings
Assists with the development of policies/procedures
Tracks Engineering Change Instruction’s to ensure operators are performing task correctly
Trains less experiences members on process and/or system
Any combination of education and experience equivalent to an Associate’s degree and 5-8 years experience in a quality environment
Proficient in Microsoft Office, Quick Place, Proquis, Oracle, and/or statistical software

Quality Systems Auditor Resume Examples & Samples

Develop and execute regional internal audit schedule
Collaborate with Regional Quality System Auditors and Quality/Compliance VPs to develop and maintain corporate audit standards and procedures
Engage local site Quality teams in regional audit program, utilizing local resources to perform cross-site audits, ensuring annual independent review of each site's quality system processes
Compile regional audit findings for reporting to corporate management and to identify development and training opportunities based on audit finding trends
Perform audits, including preparation, conduct, and issuance of final audit report
Assist with the local site teams to develop robust corrective action plans to address compliance gaps
Assist in the assessment and development of auditors through training and mentorship
Perform periodic supplier audits on behalf of sites, to facilitate qualification or address potential issues with suppliers
Support Regional VP and Quality Management as necessary through assigned tasks and projects
Certification as a Quality Auditor from ASQ, RAPS, ISO or equivalent
Excellent interpersonal, written and verbal communication skills, including ability to make clear, well founded decisions regarding conformity during audits
Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time
Ability to travel, including valid driver's license (position entails travel)
Proficient with MS Word, Excel, Power Point, and management of spreadsheets
Bachelor's Degree in Life Science, Engineering, or equivalent
Minimum 5 years Quality experience in medical device industry, including; experience as a Quality Systems Auditor, competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ 21CFR820 QSR, ISO17025 / ISO22301 etc) knowledge of relevant laws and regulations (e.g. CE/ FDA/ PAL) and competency in conducting technical review of all documentation and files related to product conformity requirements
Broad knowledge of engineering and technical applications applied in development of medical devices useful

Quality Systems Group Lead Resume Examples & Samples

Provide skilled technical administrative support to the Quality Team and Production Streams and ensure a standardised approach to QMS activities on site
Provide guidance and on-going support to facilitate compliance with Quality / Regulatory policies, Food Safety Programs (HACCP) procedures and product specifications
Promote a high standard of awareness and understanding at site level of all appropriate policies, procedures and product specifications
Lead the Quality Systems team to ensure they are engaged and high performing with a focus on problem solving and team work
Build trust through effective leadership and the skilled application of people management processes and open 2 way communications
Check that standards set within the Quality function are adhered to through layered confirmation
Continuously improve standards set by facilitating and executing 8 Step Practical Problem Solving and other appropriate methodologies within the Technical function and as required within the Production Stream
Maintain product quality and safety through management of the Quality Systems Team ensuring Standards are defined for quality assurance processes, operational practices and product quality
Develop site Quality Management System (QMS) framework procedures to incorporate Client, Regulatory, Customer and 3rd Party Standards (policies, procedures, COP's)
Develop process quality documentation ensuring alignment with Client, Regulatory, Customer and 3rd Party Standards. This will include Process Inspection Schedules
Liaise with Competent Authorities on site quality / technical issues relating to the manufacturing process such as consumer complaint investigation or factory audit
To include Collation and reporting of NCs to VS or relevant person, close out of NC's upon receipt of verification, prepare and agree formal audit response with relevant parties prior to approval by site TM, facilitation of mock product recalls and traceability challenge

Global Quality Systems Training Manager Resume Examples & Samples

Assess current practices and procedures for site-based training and training programs
Identify key site contacts and establish teams at sites worldwide to cooperate in the development of a standardized training model
Develop standardized curricula in collaboration with senior leadership, support training design and oversee training assignments
Develop strategies to ensure adequate collaboration and communications towards the appropriate management of SOPs, processes and training
Drive process improvement initiatives by collaborating and communicating with peers and relevant functions
Develop and implement communication plans designed to provide clarifications on the interpretation of regulations, perform assessment of existing process and training needs and recommend solutions for issue remediation, as necessary
Identify, recommend and implement, as agreed with management, appropriate tools and technology to support training
Serve as global subject matter expert for standardized training issues
Must possess in-depth knowledge of all major regulatory requirements including U.S., E.U., Australian, Japanese, WHO, PIC/S, and ICH regulations and guidances. Must be knowledgeable of cGMP trends and industry direction. A formal trainer qualification is desirable
Experience in instructional design, education, training or equivalent expertise is required. Effective written and oral communication, collaboration/negotiation skills and proven record of being an effective team player are required. Knowledge of and direct experience with a LMS system is required. Must be proficient in leading discussions of complex topics and have a working knowledge of Microsoft Office including Word, Excel and Lotus Notes
Minimum of a Bachelor's degree (or equivalent) and minimum of 6 years of experience. 10 years experience in pharmaceutical industry with 8 years in a quality role is preferred. However, a combination of experience and/or education in a regulated training environment will be taken into consideration
Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization

Lead, Quality Systems Resume Examples & Samples

30%: Risk Management Activities
Lead the implementation of Risk Management programs and processes
Develop Risk Management policies, procedures and supporting methodologies
Serves as facilitator of R&D Risk Council
Responsible for coordinating the Risk Management approach including the management of the Risk Register program
Execute and provide advice for, in collaboration with functional owners and risk coordinators, formal risk assessments
Maintain Risk Management related records including risk assessment reports
Provide Risk Management related training including training on tools and processes to stakeholders
Lead a network between QA&C and functional areas to collect and analyze risks from a range of internal sources
Develop tools and processes (e.g., risk profile report) for consistent risk reporting, escalation and management control
30%: Root Cause Analysis (RCA) / Corrective and Preventative (CAPA) Investigations
Liaise and support departmental teams / individuals to conduct and document investigations (e.g., RCA) and timely completion of investigation documents
Support department teams / individuals perform root-cause analysis and appropriate corrective action and/or preventive action plans to resolve and prevent recurrence of events
Revise or develop Standard Operating Procedures (SOPs) as defined in CAPAs or to drive continuous improvement in R&D
Utilize appropriate risk management tools for events to ensure proper disposition of materials
Drives organizational improvement through clear reporting of quality issues (non-conformance, internal and external audits, CAPA, customer feedback, and proficiency testing)
Provides leadership and excellent internal communication skills to coordinate process improvement strategies
20%: Inspection Readiness
Key member of the R&D QA&C Inspection Readiness Team
Responsibilities include, but are not limited to, retrieving information from applicable R&D QMS technologies in support of regulatory authority requests either prior to, during or after an inspection, contributing to the inspection readiness toolkit, etc
Works in close collaboration with global R&D departments to implement procedural and compliance related trainings in support of the R&D QMS
Facilitates and works closely with functional areas to compile information for HA Dossiers
20%: Line Management & Quality Operations Leadership
Managing Performance: Ensure every employee knows what is expected of them, what it takes to be successful, and how they are progressing. Hold everyone accountable to achieve results while demonstrating Shire values
Bachelor’s degree in science, business or technical related field is required. An advanced degree is preferred
Previous experience with Quality Management System technologies is required
Working knowledge of ICH risk management tools, Failure Mode Effects Analysis (FMEA), and/or lean/Six sigma concepts
At least 10 years of Pharmaceutical experience supporting GxP systems, with direct management experience
Seasoned professional in managing GxP Quality Systems (QA and QC) for drug/device combination products with a thorough knowledge of US, EU and ICH regulations, guidelines and requirements
Inspection support experience is desirable

Quality Systems Applications Manager Resume Examples & Samples

Maintain on-going dialog and relationship with Quality and Regulatory teams to identify information technology needs and requirements
The Manager is responsible for the policies and IT quality oversight of the development, approval, and execution of Computer Systems Validation (CSV) and qualification activities (Quality System Applications, embedded software and Enterprise Systems)
Responsible for compliance to regulations and company procedures pertaining to validation and qualification process and procedures activities
As the leader of a small collaborative team, this hands-on manager will need to wear many “hats”, including team building, capacity planning, project management, systems architecture, and potentially some business analysis and 3rd tier support, depending on needs and depth of experience they are able to provide
The Manager leads/guides and supports implementation of process/product improvement projects
This person will lead a strategic portion of the IT department in a fast-paced environment within a highly innovative, growth-oriented company. It is an exciting role for someone ready to take on big challenges and embrace modern technologies to help drive a business forward
Education Required

Materials Control Quality Systems & Documentation Specialist Resume Examples & Samples

40% Quality systems management (as described above)
50% Documentation Lead (as described above)
10% Group administrative duties
1 – 3 Years experience working in a cGMP environment
Experience conducting Deviation investigations, and CAPAs
Working knowledge of GMP Warehouse/Manufacturing Operations
Experience with controlled/temperature sensitive GMP Raw Materials, General Supplies and Drug Substances
Experience working with Trackwise, SABA and Master Control systems
Previous technical writing experience

Quality Systems Co-ordinator Resume Examples & Samples

Change Control system - Review DCO's for content and completeness
Undertake internal audits, draft reports and follow-up on resulting actions as required
Review and log NCEs and issue status reports as required. Manage NCE board presentation, minutes, actions as required. Provide support to colleagues in raising NCEs including deviations
Develop and undertake induction and routine quality training of new and current employees
Provide support to colleagues in raising NCEs including deviations
Provide Quality support to manufacturing Phase I & Phase II
Review batchcard, release batchcard and shipping documentation for completeness
Update Standard Operating Procedures, Work Instructions and Quality Related Documentation as required
To actively promote Quality in the Company and demonstrate a knowledge of GMP to internal and external stakeholders
To assist in managing/coordinating the Company quality system in line with regulations
Any other duties as determined by the Quality Systems Manager
Third level qualification with relevant work experience in the quality sector
Experience in a QA role or working to an ISO quality standard
Good knowledge of ISO 13485, GMP and 21 CFR 820 an advantage
Minimum of 1 years' experience in a similar role, preferably in a large company or with a related service provider to industry
Good level of technical and analytical expertise to assist in problem solving

Quality Systems Co-ordinator Resume Examples & Samples

Provide leadership in the development and management of Quality
To review and ensure the team organizational capabilities, personnel competencies and that the number of qualified personnel continuously matches expertise and workload needed
Owner of the Management Review Process through execution of quarterly reviews and providing adequate data analysis and proposing improvements where needed to maintain a state of compliance
Supports the QS Manager in coaching and mentoring the QS team to ensure professional and personal development of department personnel
Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained
Actively participates in management of the Quality Department through budget forecasting and preparation, training of staff, and deputizing for other members of the department management team as appropriate
Coordinates QS staff in the development and implementation of systems and procedures for the management of change control, as it applies to plant installations, systems, and operations in accordance with GMP
Coordinates the development and implementation of systems and procedures for the management of non-conformance investigations and root cause problem solving as they apply to site operations
Coordinates QS staff in the development and implementation of systems and procedures for the GMP qualification of service providers
Coordinates QS staff in the development and implementation of systems and procedures for internal audits. Assists Senior Quality Director and QA Managers in management of quality inspections and audits of by external parties/agencies. Manages the tracking of commitments arising from audits and communication of information to site management on commitment completion
Deputizes for the QS manager as appropriate
Gives direction to the QS Group in the execution of their duties
Coordinates the activities of the group within quality to create a synergistic approach to goals and tasks
Through personal expertise, leadership and commitment, provides direction to the site in the development of a culture of quality and compliance
Domestic and international travel may be required
Bachelor's Degree in a scientific/technical discipline required
A minimum of 5 years' experience in a quality or compliance role within the biological and/or pharmaceutical industry
A minimum of 3 years management experience required
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position
Demonstrated knowledge and application of industry regulations including those of FDA,HPRA, EMEA an Excellent interpersonal skills

Quality Systems Consultant Resume Examples & Samples

Leads project teams responsible for the design and implementation of systems for quality management and continuous improvement of products or solutions across multiple segments and business areas
Consults with senior business leaders to identify relevant internal, client and external quality standards and measurements for the assigned areas; develops overall quality management framework, including policies, documentation, training and assessment plans, to meet and exceed quality requirements
Manages and expands relationships with internal partners, clients and industry standards organizations for quality audits, quality management and building quality culture
Drives innovation and integration of new technologies and initiatives into quality projects and activities
Bachelor's or Master's degree in Quality Management, Business Management, Engineering, Computer Sciences, or equivalent
Audit/assessment certification preferred
Project management certification such as PMP/PMI certification preferred
Experience designing and implementing overall quality management and improvement frameworks to ensure adherence to quality requirements
Excellent analytical, statistical and problem solving skills
Thorough understanding of and experience in applying industry quality standards and methodologies to business situations

Quality Systems Auditor Resume Examples & Samples

Perform supplier facility audits (as defined by SQ procedures)
Drive effective closure of supplier corrective action plans to address gaps identified during the supplier facility audits
Identify, prioritize and implement new initiatives or special projects by gathering and analyzing data in order to drive supplier development
Perform SME activities and support problem solving, and project activities as requested
Participate in training to build capability and support personal development
At least 5 years related work experience (preferably on nutritive sweetener and beverage gases)
Knowledge of relevant professional auditing standards such as ASQ, ISO and HACCP
MS Office Skills: Ability to use MS Office programs (Excel, Word, and PowerPoint) to effectively conduct assessment, analyze data and construct presentation
Attention to Detail: Accomplishing tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checking processes and tasks; being watchful over a period of time
Audit Data Analysis: Ability to use sampling strategies to gather data and perform analysis to identify activities and trends
Problem Solving Analysis: Forming an opinion or making a decision through careful testing of assumptions and facts; taking action that is consistent with available facts, constraints, and probable consequences
Establishing Collaborative Working Relationships: Developing and using collaborative relationships for the purpose of accomplishing work objectives; developing relationships with other individuals by listening, sharing ideas, and appreciating others' efforts
Process Improvement: Evaluating existing processes and identifying more efficient ways to accomplish goals and meet customer and client requirements; continuously improving the processes through regular assessment and adjustment. 6-sigma Black/Green Belt Certified

Senior Auditor, Quality Systems Resume Examples & Samples

Performs audit scheduling and leads or participates as an audit team member
Performs training of auditors and is responsible for continuation training and evaluations of Auditors
Primary responsible person for completion and oversight of audit reports
Primary trainer to the company for root cause analysis, risk analysis, and process improvement techniques
Perform as the subject matter expert for ISO, AS, IOSA or IS-BAO issues or training
Develops effective process data collection tools, controls, and methods and trains other team members
Prepare formal written reports backed by adequate evidence to support audit conclusions on the adequacy and effectiveness of the audited system and or organization
Evaluate, monitor and follow through on issues/problems discovered in audit process to final resolution and implementation
Assists functional department heads to assist with the identification of root cause and resolution of audit findings
Work with management to develop risk based tools and techniques to strengthen operational programs, processes and controls using Lean/Six Sigma or other approved methods
Perform special analyses and reviews upon request, including system implementations and/or safety and compliance investigations
Performs data trend analysis and reporting
Develops and maintains the annual audit/evaluation plan
Participates in prioritization of planned evaluations using risk assessment techniques
6-10 years of aviation experience preferred in the areas of safety, audit and or maintenance operations, quality assurance or related function
High degree of working knowledge of CRF Part 135 and/or Part 145 regulations
High degree of knowledge related to Federal Aviation Regulations, DOT, and other government regulatory requirements
Willing to travel internationally to areas of conflict
BA/BS from an accredited University in Aviation Management, Business or related field or 6 years equivalent combination of education and experience
Possess an ATP/Commercial pilot or A&P mechanic certificate
Teamwork - Builds alliances, partnerships & collaboration with others including those different from him/her; deals tactfully with others; assumes helps with a variety of team roles
Initiative & Innovation - Generates new ideas personally & encourage team to do the same; stays up-to-date on technology & approaches to work; provides creative solutions & input when faced with challenges

Quality Systems Coordinator Resume Examples & Samples

A minimum of Bachelor’s degree ((or equivalent degree) is required
A scientific/technical discipline or business analyst function is preferred
A minimum of 4 years of experience in a GMP environment is required
Experience executing and/ or reviewing investigations, CAPA’s, and Change Controls is required
Working knowledge of SAP is preferred
Demonstrated knowledge of computer and quality management systems and Microsoft Office skills (specifically MS Excel) are required
The ability to extract data, analyze and interpret common scientific and technical documents is preferred
This position will be based in Fort Washington, PA or Skillman, NJ. If based in Skillman, NJ, position will require weekly travel to Fort Washington, PA. Position may also require up to 10% additional travel.Quality Systems

VP, Quality & Systems Improvement Resume Examples & Samples

Bachelor’s degree required or equivalent experience
5+ years combined experience in an acute care hospital working directly on clinical quality or process improvement projects, or a national cardiac clinical quality improvement program that incorporates data capture within a process improvement framework
Minimum of 3 years of management experience
Certified Professional in Healthcare Quality (CPHQ) is preferred

Quality & Systems Improvement VP Resume Examples & Samples

Assumes full responsibility for developing and implementing regional strategic direction for the 5-state affiliate Quality and Systems Improvement team of 13 Quality Systems Improvement/Mission: Lifeline staff and administrative team members
Regularly communicates on opportunities, issues, complaints, competitive initiatives, market trends and concerns. Provides consistent, timely and effective information, direction, standards, planning, and problem resolution
Develops strategies that will drive greater results in Quality and Systems Improvement
Leads affiliate team and strategic planning focused on increasing the number of cardiovascular and stroke patients discharged annually from Get With The Guidelines-participating hospitals; advancing adoption of AHA Quality Inpatient programs through expanded market penetration as demonstrated by increased contracts for GWTG Resuscitation; increasing the number of Quality Achievement Awards achieved by participating hospitals; launch of AHA programs dedicating towards reducing cardiovascular disease and stroke by increasing the number of qualified provider organizations registered and implementing AHA programs; and increasing NSTEMI Discharge Population
Management of affiliate Quality and Systems Improvement budgeted projects, corporate and grant-funded programs and for market prioritization which leads to development and implementation of programs as needed to support Quality and Systems Improvement
Broad knowledge of hospital processes, care pathways and hospital political culture
Experienced in influencing performance without direct line accountability
Knowledge of voluntary health organization or nonprofit organizations
Goal-oriented with a successful track record of meeting and exceeding measurable goals
Ability to communicate, build relationships, gain trust and effectively work with, train and inspire change across diverse audience of volunteers. Also ability to effectively utilize, measure and increase volunteer engagement at all levels
Ability to clearly and concisely exchange ideas, facts and information when engaging with health professionals and healthcare executives
Demonstrated knowledge of fundraising, grants and maintaining relationships at corporate, government and community levels
Ability to conceptualize, reason through problems, make effective decisions and develop alternative solution and provide excellent customer service while ensuring compliance with the American Heart Association’s policies and procedures
Must be able to lift up to 20 pounds with the expectation that items in excess of 20 pounds would be broken down into smaller components or additional assistance is required before lifting
Ability to travel up to 80% of time throughout the affiliate including overnight travel, occasional trips to AHA National Center located in Dallas, TX and attendance at occasional meetings and events taking place on evenings/weekends including outdoor events
Five years combined experience in an acute care hospital working directly on clinical quality or process improvement projects, or a national cardiac clinical quality improvement program that incorporates data capture within a process improvement framework
Minimum of 3 years of management experience or in progressively responsible positions

Quality & Systems Improvement Director Resume Examples & Samples

Identifying, cultivating and maintaining key market stakeholder relationships impacting program goals such as: local business coalitions, hospital systems or health plans
Coordinate and conduct Get With The Guidelines account management activities for assigned hospitals in market including implementation and quality improvement consulting
Market and implement the programs including the Stroke, Heart Failure, Resuscitation, Atrial Fibrillation Patient Management Tools, as well as Action Registry- Get With The Guidelines
Provide hospital training sessions for Patient Management Tool (PMT) data entry and PMT data reporting as needed
Consult with appropriate hospital teams with respect to the compliance issues and strategies
Responsible for the accredited and non-accredited workshops in primary market
Interact with appropriate affiliate staff and volunteers to leverage opportunities and provide seamless customer relationship management
Conducting follow-up activities with the hospitals
Support Mission: Lifeline state or regional task forces as appropriate to drive consensus on ST Elevated Myocardial Infarction (STEMI) Systems of Care including but not limited too all EMS systems in the market
Overall customer relationship management
Likely serve as Account Manager for state of stakeholder relationships impacting program goals such as Departments of Health or Quality Improvement Organizations as assigned by Vice-President
Execution of all necessary pre-work activities required to launch all future GWTG modules in a market including: the oversight and execution of ASTP, TJC Primary Stroke Center and similar programs as necessary
Trouble-shooting and follow-up on specific customer issues
Clinical knowledge and experience that demonstrates the ability to execute local and regional strategies based on affiliate and national priorities, managing multiple projects, and cultivating relationships with key stakeholders and program implementers
Demonstrated understanding of patient care and/or clinical quality or process improvement management in an acute care hospital
Clinical knowledge of cardiovascular disease and/or stroke treatment and metrics desired
Knowledge of the operating methods and ethics of voluntary, non-profit organizations and health care delivery system professionals
Ability to understand, interpret and communicate data and data relationships in a healthcare environment
Ability to independently organize and prepare data for reports and presentations
Ability to organize and successfully prioritize work to meet deadlines with close attention to details
Ability to plan and conduct meetings and trainings
Ability to travel within the affiliate territory and travel outside the territory to attend training sessions and related activities related to professional programs. This may require overnight stays and/or weekends. Percentage of travel up to 50% predominately within the assigned market with periodic overnight stays
Ability to use Microsoft products, computer software, run reports, maintain accurate data and learn new software applications
Must have the ability to lift at least 20 lbs from the ground to waist level with or without reasonable accommodation
Satisfactory background checks
Bachelor’s degree from an accredited university in Nursing, Healthcare Marketing or Public Health required. College coursework combined with related experience may be substituted for a degree. Related experience may be substituted as follows: 1 ½ years’ experience equates to 1 full time year of higher education
Must have at least 2 years of experience in healthcare clinical or quality improvement and in building and managing relationships with external alliances. This experience may also count towards satisfying this position’s educational requirement

Quality Systems Consultant Resume Examples & Samples

Bachelor's or Master's degree in a technology or manufacturing-related engineering discipline or equivalent
Extensive experience with using engineering tools, automation, and software packages to design and automate manufacturing processes
Conducting reviews of material specifications and hardware and electrical component design
Evaluating forms of empirical analysis, modeling and methodologies to validate manufacturing process and tooling design and specifications
Ability to effectively communicate manufacturing architectures, plans, proposals, and results, and negotiate options at senior management levels
Bachelor's or Master's degree in a technology or manufacturing-related engineering discipline or equivalent. Preferred Chemical or Industrial engineering background
Works with minimum supervision
Ability to handle pressure
Interacts with high-level Individual Contributors, Managers and Program Core Teams
Collaborates with peers, junior engineers, technicians, and external and internal manufacturing and design partners
Good team working and communication skills
Leads a project requiring manufacturing engineering development
Using empirical analysis, modeling and methodologies to validate manufacturing process and tooling design and specifications
Ink manufacturing processes knowledge desire
Using engineering tools and software packages to design and automate manufacturing processes
At least 5 years experience in manufacturing is required

Quality Systems Technician Resume Examples & Samples

Interpret OEM (Original Equipment Manufacturers) specifications with the intent of converting them to work instructions for operational use
Develop controlled/frozen work instructions for specific part numbers and processes per OEM requirements
Develop and/or assist in the development of procedures for operational processes and the quality management system
Provide technical support of operations through application of quality assurance practices to improve quality of products, processes, work instructions and overall process efficiency
Assist in the technical maintenance of customer approvals for a wide variety of OEM specifications
Maintain document control, both internal and external documents
Perform internal quality audits and assist with external OEM/Customer quality audits
Act as a quality assurance liaison for customers both internal and external
Define, implement, and maintain process controls; resolve root cause of failures or rework using analytical and statistical methods that may result in changes in tolerances, standards, or processing methods
Monitor quality of production part outputs; perform reviews of technical issues with other departments for corrective action or continuous improvement initiatives
Assist in development of other technical experts
Work one-on-one with our customers to rectify PO issues, interpret specifications and drawings, as well as investigate rejections
Assist shop personnel by providing them with the information and technical quality support needed to perform their processes efficiently
Develop and deliver drawing, work instruction, process procedure, and specification training
Assist others as requested or needed and other duties as assigned
Other related duties as needed or assigned
Must be a self-starter, able to work independently and have the ability to work with customers (both internally and externally)
Has the ability to work autonomously
Ability to rapidly adapt priorities and respond to changes in a fast-paced environment
Creative problem solving and strategic thinking skills
Strong computer skills using MS Office products as well as ERP system experience is desired, Syteline experience preferred
Ability to read, analyze and interpret data and technical specifications, including customer drawings and blueprints - able to recommend changes to internal procedures and documents
Ability to facilitate cooperation from internal departments
Must be able to meet tight deadlines
Bachelor’s Degree OR Quality-related certification and 5+ years of relevant work experience desired; aerospace manufacturing or finishing experience preferred
Aerospace industry experience preferred, some knowledge of the surface finishing industry is a plus
Extensive knowledge of quality assurance theories, principles, practices, techniques, and concepts; familiarity with AS9100 and Nadcap requirements preferred

Quality Systems Coordinator Resume Examples & Samples

Certified as an ISO/TS16949 Lead Assessor (Preferred)
Strong verbal and written communication skills, ability to influence behavior through positive dialogue and have strong quantitative and analytical skills
Strong computer skills in Microsoft Word, Excel, Project, Minitab (or similar)
Fluent in English (reading and writing)

Quality Systems Aide Resume Examples & Samples

2 years of college preferred
1 year or more in QA Department (preferred)
Broad knowledge of Quality System procedures
General knowledge of manufacturing procedures
Knowledge on GMPs, Quality System Regulation (QSR) ISO 13485 and Documentation Practices
Hands-on experience with Microsoft Word, Excel, Power Point, Windows, etc

Quality Systems Training Coordinator Resume Examples & Samples

High School diploma or GED with 4+ years’ experience in a training administrator/coordinator role OR Bachelor’s degree and 2+ years’ experience in training administrator/coordinator role
Experience working with a Learning Management System (e.g., ComplianceWire, Saba, Cornerstone OnDemand, and/or Plateau)
Experience with course authoring software (e.g., Articulate, Captivate, BrainShark, Saba Publisher or third-party vendor applications)
Knowledge of medical device quality system regulations (21 CFR Part 820) and ISO 13485
Experience with adult learning methodologies and principles of instructional design, curriculum development and instructional needs analysis

Senior Quality Systems Compliance Specialist Resume Examples & Samples

Support quality management systems operation within the organization
Ensure assigned quality actions, and all internal and external audit observations, are investigated, have causes, identified actions plans completed, and appropriate effectiveness monitoring performed to the agreed schedule
Drive Compliance improvements, which result from internal audits, Management review meetings and other system indicators
Supports the administration and configuration of Quality Management System, MasterControl
Reviews and approves Non-conforming events (NCE), Laboratory Investigation Reports (LIR), and CAPAs
Maintains awareness of activities by routine direct observation of testing laboratories and manufacturing suites. Interact frequently with operations/facility staff to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management
Write and revise SOPs as necessary to ensure compliance, efficiency and clarity
BA/BS degree in a Science related major
Ability to accomplish the described duties through the use of appropriate computer equipment and software (especially Microsoft Word, Excel, and Outlook)
Knowledge of EU cGMPs highly desirable
Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, and Access)
Ensures document maintenance is adhered to. (i.e.: biennial SOP reviews)

Quality Systems Team Leader Resume Examples & Samples

A minimum of a Bachelor's degree or equivalent is required
A minimum of 6 years of experience in an FDA/GMP regulated environment is required
Experience working in a Quality related role in a FDA/GMP regulated environment is required; broad based quality systems experience is a plus
Experience developing training materials/programs and delivering training to others is required
Knowledge of concepts associated with GMP training, document control and product complaints quality systems is required
Proficiency in Microsoft Office Suite is required
Experience with technical writing in a FDA/GMP regulated environment is required
This position will be located in Fort Washington, PA and will have up to 10% domestic travel
Supervisory experience is preferred
LMS, EDM, ERMS, PQMS experience is preferred
E-learning authoring experience is preferred
Investigations and CAPA training/skills experience is preferred.Quality Assurance

Associate, Quality Systems Resume Examples & Samples

Assist with workflows upon receipt of revision requests for all controlled document types (SOPs, forms, Quality Standards). Issuance of reports for revised documents including archival of superseded documents. Assist with biennial review workflows for controlled document types (SOPs, forms, quality standards) by issuing LOS reports. Write, review and update SOPS for forms related to areas of responsibility
Maintain training database and upload quizzes into the LOS training system for new/updated procedures
Assist as necessary to maintain filing system/training database. Assist with annual archiving, as needed
Customer service functions assist with IDEA for CON and LOS issues, address issues with quizzes in the training system
Provide second check of records prior to issuance
Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI’s excellent reputation in the community
Must have Document Coordinator certification for use of IDEA for CON

Senior Specialist, Quality Systems Trending Resume Examples & Samples

Provide technical support for the Product Quality Complaint (PQC) program: assist with entry of PQCs, triage incoming PQCs and applicable adverse event complaints by assess the need for expedited investigations and field alerts, submit field alerts and follow up field alerts, and develop and maintain associated trend reports. Backup case handler for product quality complaint investigations
Complete assigned sections associated with Annual Product Reviews (APRs). Analyze APRs and write APR summary reports
Assist the head of Quality Systems with the development and maintenance of Key Performance Indicators, Quality Indicators, metrics and scorecards for BIV-US and corporate, as required. Assist with assembly of information, agenda and minutes associated with BIV-US review boards
May perform assigned internal, supplier and external audits based on qualifications. Complete all audit documentation as required and on time
Develop individual Max Plan to align with functional goals and objectives and establish development plan. Request training, coaching and feedback from management when needed
Assist with inspection readiness and preparation activities as required by management
Develop assigned documents and perform QA review and approval of assigned documents
Perform other duties and projects as assigned by management
Ensure compliance for areas of direct responsibility

Manager, Global Quality Systems Resume Examples & Samples

Must have expert GMP, Quality, and in-depth risk management knowledge
Must be able to note technical/scientific attributes in potential situations or issues and process science based solutions across a majority of the job function
Must have strong authorship and be able to critically review reports while effectively inputting and expressing Quality risk management principles
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Must possess an independent mindset and tenacity
Completes routine tasks with no supervision; Confident in making non-routine decisions in their subject matter area; Able to work proactively. Drives continuous improvement and improves efficiency and productivity within the group or project
Leads cross functional project teams driving performance and results. Skilled at getting resources and information from internal and external contacts
Manages conflict and issues with internal and external customers. Able to recognize conflict and notify management with proposed recommendations for resolution
Builds and leverages relationships and provides advice internally within function and with global cross-functional teams. Negotiates solutions cross functionally
Identify and implement best demonstrated quality and compliance practices and systems across multiple sites
Develop and implement global processes and systems
Work cross functionally to deploy throughout the organization
Ensure continuous improvement of quality systems
Maintain global Quality Manual defining Celgene’s global Quality System
Manage Global Quality Agreement system
Develop and deploy global procedures and templates for clinical and commercial products
Support stakeholders in development of quality agreements
Oversee Global Recall processes
Maintain system documentation in compliance with global Health Authority requirements
Develop and implement a globally harmonized mock recall process
Support ERP processes related to product recall
Manage Annual Product Quality Review process
Develop harmonized site and global processes. Maintain global Procedure
Implement and maintain site and global templates for drug substance and drug products, as applicable
Manage the Global Management Review program to effectively monitor Celgene’s quality systems at the global level and ensure continuous improvement
Create and maintain templates to capture data from global stakeholders
Analyze and interpret data; generate charts/graphs to communicate results and trends
Manage global process for evaluation of emerging and revised GMP regulations and guidance documents
Business process owner for Enterprise Laboratory Systems. Develop and implement processes, systems and documentation and assure consistent and effective deployment throughout the organization
Establish data integrity requirements related to laboratory data and implement procedures and work practices governing associated processes
Support electronic and paper document control systems at the site and global level
Provide support during internal and health authority inspections of facilities and CSPs
Lead transition teams and develop plans and actions to support acquisitions, collaboration agreements, new market expansion and other quality management activities
LI-KM1
Relevant college or university degree preferred. Equivalent combination of education and experience acceptable
Bachelors of Science
7-8 years of Pharmaceutical Experience
Experience with PC based office computers and standard Microsoft Office applications
Experience with SharePoint
Experience with electronic document and data management systems

Director, Global Quality Systems Resume Examples & Samples

Must have expert GMP, Quality, and risk management knowledge that impacts the department or global function
Must be able to critically interpret problems and effectively communicate in an impactful manner to management, the group, and the broader organization with clarity and a high level of brevity and accuracy
Must be a technical/scientific expert. Must be able to measure technical/scientific attributes in qualitative ways and drive science based decisions across the organization
Must manage technical teams across the organization
Must have expert authorship of technical documents. Must be able to recognize the impact beyond a single project or collaboration
Must be skilled in strategic thinking, managing through systems, navigating politics, innovation management, and negotiation. Must possess a strategic perspective, leading vision and values, global acumen, and leadership disposition
Responsible and accountable for the development of effective and efficient procedures and work practices governing global quality systems in cooperation with regional and site functions
Develop and maintain global GMP/GDP Policies and the Quality Manual defining Celgene’s global Quality System
Establish strategic direction and direct the development, implementation and execution of

Quality Systems Associate Resume Examples & Samples

Review and approve internal investigations (deviations, OOS);lead or manage open investigation and consult for internal GMP functions
Provide support and consult for CAPA development
Maintain key QMS tracking systems and performance metrics
Manage Avid internal audit program including setup schedule and ensure audit performed according to scheduled
Manage change control system
Manage GMP training program
Develop and manage continuous improvement program including CAPA, quality plan
Collaborate with EU QA and CMC personnel on systems related data
Support GMP regulatory intelligence monitoring, driving feedback, risk analysis, and reporting
Support data management and reporting for the Avid quarterly management review
Plan and lead corporate audit /regulatory Inspection
Bachelor’s degree in Pharmacy or other discipline relevant to drug discovery, development, or commercial products
Minimum 7 years of Quality Systems/Assurance experience in a regulated environment such as GMP or ISO
Knowledge or experience in aseptic processing environments and analytical testing, e.g. HPLC, GC, residual solvents, impurities, sterility and endotoxin testing. Parenteral therapeutic drug development experience is strongly preferred
Strong knowledge of relevant regulations of US and European drug GMPs, ISO a plus
Knowledgeable in Quality Management Systems (FDA or ICH approach to risk management and QMS)
Working knowledge of third party manufacturing and contracts preferred
Experience in compilation and review of Annual Product Reviews (APRs)
Ability to audit GxP processes and Quality Management Systems
Experience with review of CAPA reports, Master Batch Records, SOPs, change control, validation protocols and reports, QA agreements, and audit reports
Experience in regulatory inspections
Ability to assess Quality System related procedures for their effectiveness and make improvements, as necessary
Proficient in Microsoft Office Suite, especially MS Excel (with formula and macro functionality) strongly preferred
Ability to simplify complex processes/problems and propose alternate solutions
Ability to identify and manage risks to project timelines
Multi-lingual preferred

Senior Specialist, Quality Systems Resume Examples & Samples

Provides guidance and direction to Validation and Technical teams regarding development, implementation and validation strategy for changes to and implementation of computerized systems including
Appropriate SDLC phases to apply based on change or system complexity and risk
Validation strategy to meet Gilead policies and regulatory requirements
Validation Protocols and Reports
Validation Plans
IQ, OQ and PQ Protocols
Validation Summary Reports
Traceability Matrices
SOPs, Forms and Work Instructions
CAPAs, Deviations and other compliance related documents as needed
LI-JS1
7+ years of relevant experience in a GMP environment related field and a BS or BA
5+ years of relevant experience and a MS

Quality Systems Supervisor Resume Examples & Samples

Report to and assist the Quality Manager in the enhancement and maintenance of Quality Systems and site adherence of those systems
Support the Quality Department in maintaining a comprehensive audit-readiness program to ensure internal and external compliance including executing of audits and reporting of findings
Liaise with all Department Managers and area specialists as required to implement and maintain an effective, compliant and continuously improving Quality Systems
Oversight of Product Quality Reviews and ensuring that the annual schedule is adhered to
Review of supplier and product complaint investigations and ensure the complaint closure rate is in line with company procedures and global metrics
Ensure that GMP training is rolled out annually at a site level
Oversight of deviation system ensuring CAPAs and deviations are closed within required timelines and ensuring CAPA effectiveness is monitored
Oversight of Change Controls ensuring ongoing compliance to product registrations and maintaining facility and equipment qualification
Oversight of Technical Agreements compilation and amendments and liaise with all Department Managers on Product Launches/Transfer/Switches
Ensure trending reports for deviations, supplier complaints, complaints and environmental monitoring are completed in a timely manner and any adverse trends are highlighted
To co-ordinate and participate in site Corporate and Health Authority Audits
To adhere to all company and legislative health, safety and environmental requirements and to carry out any other duties as assigned by the QA Manager or Quality Director
Third level qualification in science related discipline
Minimum three years experience within the pharmaceutical industry
Strong leadership and organisational skills and proven track record as a team player
An excellent knowledge of, and practical experience in developing and maintaining Quality Systems which meets the legislative requirements of human medicines in the European authorities
Experience in delivering training to relevant personnel on the correct application of the site quality system procedures
Experience in support and preparation for regulatory audits from either the European or FDA authorities
An ability to organise and prioritise tasks, be detail orientated and self-motivated and demonstrated ability to deal with complex issues

Manager, Risk Management & Quality Systems Resume Examples & Samples

Work with various departments to assess risk associated with each process and/or operation to assure product quality
Establish, implement, and maintain QRM systems, including writing SOPs, establishing QRM teams, and providing training
Author, review, and approve risk assessments using standard methods including (but not limited to) Failure Modes Effects Analysis (FMEA), Cause and Effect Diagrams, Fault Tree Analysis (FTA), and Design of Experiments (DOE)
Use risk management methods in support of investigations, development, clinical manufacturing, commercial manufacturing, validation, and continuous improvement
Ensure risk and risk management are communicated to senior management and stakeholders in a timely manner
Ensure discrepancy investigations, CAPAs, and effectiveness checks meet GMP requirements and are accurate, complete, and well written; perform root cause and impact assessments using applicable tools (for example, fishbone diagrams, 5 whys, FMEA)
Track quality system records; work with department stakeholders to ensure that records are closed on time
Represent QA on multi-disciplinary project teams
B.A. or B.S. degree (preferably in Life Science) is required with at least 7 - 10 years of experience in the pharmaceutical or biopharmaceutical industry
Must have sound knowledge of cGMPs, excellent technical writing skills, and meticulous attention to detail. The ability to interpret and relate Quality standards for implementation and review is essential along with the ability to make sound decisions about scheduling, allocation of resources, and managing priorities
Technical competence in risk management/Six Sigma methods (e.g., DMAIC, DFSS, Quality Management Tools, Kaizen, statistical techniques, 8D, Root Cause Analysis, FMEA, and PFMEA)
Must be able to communicate clearly and professionally both in writing and verbally. Flexibility in problem solving, providing direction and work hours to meet business objectives is essential

Supervisor, Quality Systems Resume Examples & Samples

Author, review, and approve discrepancy investigations (including deviations and OOS/OOL/OOT results), CAPAs, and effectiveness checks
Trend quality system records; prepare and report quality system metrics
Identify and implement process improvements
Author, review, and approve procedures, protocols, reports, specifications, and other GMP documents
Supervise a group of 1-2 direct reports
Provide both formal and informal (ad hoc) training to coworkers on relevant processes (including quality systems, risk management, and GMPs)
Provide support during regulatory and other inspections; maintain a state of inspection readiness
Perform other duties as assigned by Quality management
B.A. or B.S. degree (preferably in science) is required with at least 3-4 years of experience in the pharmaceutical or biopharmaceutical industry

Head, Quality Systems & Training Resume Examples & Samples

Lead person for creating and implementing process improvement, compliance, standard operating procedures, best practices, and lessons learned for the NA CSU organization responsibilities, including applicable KPIs
Implement improvements and track progress to enhance the NA CSU training program. Provide input for additional clinical monitoring related training
Responsible for oversight of the IP management team for NA CSU studies
Provide supportive and advisory capacity to therapeutic groups within the NA CSU
Interface with all required corporate functions to standardize clinical operational processes, (i.e.: CSO, CQ&I, Trial Operations, CSU Network, Clinical Supplies)
Oversight in the development and implementation of NA CSU training modules (professional, GCP and skill type) in conjunction with the regional and in-house monitoring teams, both in GCPs and scientific aspects
Participate in Committees/Task Force Teams/Workgroups on an as needed basis, as requested by Management Team, to provide procedural insights and represent NA CSU interests
Responsible for the oversight of the NACSU System Support team
Responsible for the oversight of the SOP & Training Ambassador(s) as well as Training Specialist/Coordinator for the NACSU
Demonstration of strong leadership skills, communication, influencing, team management, negotiation and coaching skills required to interact with impacting departments representing the NA CSU. Prior management of department or operations group is highly desirable
Ability to think strategically & propose innovative solutions
Proven ability to mobilize a diverse team
Work experience in clinical medicine (e.g. nursing, laboratory, radiology, pharmacy), pre- clinical area (e.g. pharmacology, toxicology) and/or clinical research industry
In-depth knowledge of FDA regulations and ICH/GCP guidelines
Excellent interpersonal and communication skills (verbal & written)
Strong experience with metrics reporting
Ability to work effectively with research personnel, maintaining a professional demeanor
This position requires knowledge of computer software, attention to detail, and a passion for excellence. Understanding of clinical process and competent with clinical applications and tracking systems
Language: English
Bachelor’s degree with an advanced degree preferred. Minimum of 8-10 years of experience in the pharmaceutical industry and a minimum of 5 years managerial experience in medium to large pharmaceutical environment
Training/presentation skills & experience
Clinical development & clinical trials experience
Knowledge of key systems such as IMPACT, Clubnet, eRooms, Sharepoint, Medidata Rave, Oracle Clinical

Quality Systems Champion Resume Examples & Samples

Attend monthly QS Champion meetings
Attend or ensure the attendance of appropriate site SMEs to ad hoc meetings to discuss quality intelligence, etc
Identify site SMEs to participate on global document (Standards, GOPs, Practices) creation teams
Coordinate and facilitate gap analyses, remediation planning, training, and implementation of GQS Standards
Coordinate the implementation of Practices and GOPs on site
Provide progress and metrics for risk mitigation, standard implementation, and resolution of inspection related items
Ensure the preparation and maintenance of the Site Risk Profile Report and Site Work Plans
Facilitate and conduct formal risk assessment for critical department
Create and maintain a Site Risk Management Plan and Risk Management File based on corporate procedures
Participates in audits regarding risk management at the site level
Ensuring that risk reports are generated and approved and filed within the sites’ documentation system
Assists with the integration of Quality Risk Management principles and practices into the Quality System, along with applicable area management (e.g. communicating on a regular basis with site on risk updates, ensuring that risk is integrated within all functions at the site, mentoring site on risk practices)
Ensure the preparation and maintenance of trending and statistical analysis performed by department
Facilitate and present updates at the Site Quality Council regarding standard and guidance remediation , trending and statistical analysis and site risk profile
Provide site feedback to CQO for continuous improvements for the GQS
Proven record of work in finished labelling and packaging for parenteral products
BS/BA degree in a scientific discipline. with 10 years of experience working in a CGMP environment Or MS degree in a scientific discipline and 7 years experience
A combination of education, training and experience may be considered in lieu of the above stated qualifications
10 years of experience working in a CGMP environment
MS degree in a scientific discipline with 7 years of experience working in a CGMP environment
Experience working in Quality in a GMP environment
Ability to operate in an environment with strict timelines
Experience performing work that consistently requires independent decision making and the exercise of independent judgment and discretion in a CGMP environment
Experience demonstrating strong written and verbal communication skills
Experience demonstrating proficiency with Microsoft Office applications

Quality Systems Supervisor Resume Examples & Samples

Manage quality systems team to provide quality support to various levels of manufacturing personnel and business groups
Primary quality systems liaison between manufacturing site and other BASF sites
Ensure that Manufacturing Plant is in compliance with BASF internal guidelines as well as external regulatory agencies legal requirements and industry standards (GMP, ISO9001, Food Safety, Dietary Supplement, IPEC …)
Planning, scheduling, organizing and leading food safety and cGMP audits of BASF facilities (internal) and raw and packaging material suppliers, tollers and contract labs (external) for ENH (North America) to include reporting, corrective action follow-up and track/trend audit findings to drive GMP compliance improvement within BASF and its suppliers and to monitor the performance of the auditing program
Monitoring quality/regulatory compliance (i.e. USP-NF compendia, 21 CFR, ICH Guidelines) to ensure continued cGMP conformance and maintenance of NSF Dietary Supplement; maintain annual product and raw material certifications from Kosher/Halal organizations to include host rabbinical visits
Leads and facilitates customer and compliance audits
Responsible for developing the quality team to improve team member’s skills and capabilities
Responsible to comply with and report concerns with all applicable GMP's and the Food Safety Management System (FSMS) to site leadership. These personnel shall have authority to address concerns and implement appropriate corrective and/or preventive action to restore the FSMS to a compliant state
Manage the facility HACCP and QRA programs to include leading the HACCP team in the annual review and any new HACCP studies and/or QRA's to be conducted for new or changed products and/or processes
Manage the Food Safety Team to ensure compliance to FSSC 22000 requirements and continual improvement of the food safety programs
Oversee quality data management function to ensure data integrity, timely response of customer questionnaires and requests, support specification maintenance and manage the Quality Management of Change (QMOC) and NCM processes
Maintain applicable SOPs
ISO/RCMS/FSSC/EFfCI auditor
BA/BS (food science/technology, chemistry, biology preferred). In lieu of degree, a high school/GED diploma and 5+ years experience running a quality systems department
Minimum 1 year of experience in managing a quality systems department
Minimum 1 year experience in food, dietary supplement or other relevant FDA regulated product manufacturing
Expertise and knowledge of Food and Dietary Supplement cGMP’s (21 CFR Part 110, 111) & food safety requirements highly desirable
Demonstrated experience and working knowledge of FDA regulations, ICH guidelines, SOP implementation, as well as an understanding of sanitation and quality control principles and QA audit functions
Previous experience in leading customer and supplier compliance audits
Proven ability in leading teams, delivering feedback, coaching & mentoring
Sound systems knowledge, analytical abilities, and computer skills
Strong business writing, oral communication and time management skills
Results driven, demonstrated strong collaboration skills, decision-making ability and ability to positively influence people
Demonstrated ability to work independently and multi-task, attention to detail and personal integrity
Developed understanding of statistics and trend analysis
Detail oriented with the ability to record (via notebook or computer) and report pertinent data
Must have good interpersonal skills with the ability to work in a team environment and interact with management and employees within the organization

Quality Systems Efficiency Coordinator Resume Examples & Samples

Set up and lead work groups by involving the necessary participants (production, maintenance, methods, etc.) and by using problem solving tools (Ishikawa, 5 Why, QRQC, etc.),
Lead improvement workshops
..

Quality Systems Coordinator Resume Examples & Samples

Serve as the primary administrator of the electronic quality management system (eQMS)
Manage user profiles and role assignments
Create and maintain folder/vaults for controlled documents and quality event processes and forms
Coordinate with the various management teams and the training department in the creation of training infocards, courses, roles, etc. in the eQMS
Assist with and/or lead corporate quality systems training
Provide support and consultation on the creation, periodic review, revision and obsolescence of controlled documents
Provide support and consultation on the CAPA process, including the CAPA-intake processes and forms (such as deviations, non-conformances, complaints, audits, etc.)
Utilize structured, disciplined, and data-oriented problem-solving techniques for quality issues including but not limited to: identifying quality issues, performing formal investigations, conducting root cause analyses, writing and/or consulting on corrective action and preventive action plans
Follow-up and provide data required for key performance quality metrics related to controlled documents, CAPAs(including feeder/intake processes & forms) and continuous quality improvements
Perform analysis and report on trend data. Report and escalate system and process performance metrics to the Business Process Owners (BPOs)
Recommend organizational process improvement initiatives based on identified trends and key performance quality metrics
Maintain status reports for quality systems activities and provide to stakeholders as scheduled/requested
Support the BPOs in providing technical, procedural, and compliance based guidance to eQMS users as needed
Support training for Quality Systems processes as needed
Provide assistance to the QA Managers and QA Director as required
Work under challenging deadlines and be accountable for completing work within specified time periods
Bachelor's degree, minimum (preferably in scientific discipline)
Minimum of 2 years’ experience in a quality role preferred – specifically in SOP management, change controls, deviation investigations and CAPAs
Applied knowledge of pharmaceutical Good Manufacturing Practices or device Quality System Regulations or ISO quality standards
Working knowledge of Good Manufacturing Practices (GMP) or other Good Regulated Practices (GxP’s) as they relate to Innomar activities
Exceptional quality of work and attention to detail
Efficient in compiling, managing and interpreting data from various sources (e.g. from audits, complaints, non-conformances, etc.)
Advanced proficiency in the use of computerized systems to effectively administer the specialized electronic quality management system (eQMS) applications, as well as efficiently utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel, Visio and Adobe Acrobat)
Effective organizational, time-management and prioritization skills
Demonstrated ability to meet tight deadlines in an environment of competing priorities
Refined strategic, collaboration and presentation skills
Strong self-motivation and ability to work under limited supervision

Quality Systems Document Control Clerk Resume Examples & Samples

Enters Quality Systems data into systems and generates Quality Reports
Maintains Document Control files and document storage per records retention schedule
Provides customer service and assists in Configuration Mgt projects or issues
Updates procedures as changes are notified
Assists in Document Control and Scanning Activities
Keeps track of and communicates changes in corporate procedures for site implementation
Supports Quality Systems Department during FDA, ISO TUV, Internal audits, etc
Trains, supports and assesses skills for associates in relation to document/data applications and filing systems
Ensures compliance with Environmental Management System (EMS) responsibilities
Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable
Proficient in English/Spanish writing skills
Organized – establish work priorities
Interpersonal - effectively interact with all levels and disciplines of organization
Personal computer skills, Windows: word processing, flowcharting, project planning, desktop publishing, presentation, e-mail and spreadsheet software
Software applications associated with document & data control & control of records
Electronic document control systems preferred

Quality Systems Integration Analyst Resume Examples & Samples

Excellent data and analytical skills
Knowledge of SQL and the ability to create queries
Excellent PC skills (including MS Word, Excel and Access)
Knowledge of Hedis and Stars measures
Experience in managed care or health care administration desired

Quality Systems & Compliance Manager Resume Examples & Samples

Ensure resources are managed appropriately and in accordance with Abbott and legislative standards
Responsible for the recruitment, training, mentoring and coaching of the quality systems team
Provide leadership and direction to the plant in relation to all QA systems particularly Quality Document Management Systems (QDMS) and compliance matters
Responsible for the maintenance MUI Halal Assurance System with successful Certification in and ongoing recertification
Responsible for driving timely release of batches and ensuring Alog communication is regular and effective
Responsible for Management and Reporting monthly Batch Release and Batch Right First Metrics and drive continuous improvement initiatives
Responsible for Preparation and the Management support of external Regulatory, Division and Corporate audits within the plant. : Rosstest, CNCA, Halal, DAFM and FDA
Review and Approval of all plant procedures to ensure they are in line with AN/AQR requirements and plant expectations
Develop and lead continuous improvement projects where possible
Responsible for carrying out internal audits and compliance walkdowns and monitor compliance levels throughout the plant
To manage other Q.A. related projects as requested
This Job function will change where update procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & BOP’s are made
This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible were this need arises
Compliance Manager
Documentation Administrator
Label Copy Specialist
Complaints and Investigations Specialist
B.Sc. or equivalent in a related discipline
People management skills with proven record
Excellent interpersonal skills and management skills
Communicate with all levels of the organization
Communicate effectively with cross-functional team
Recognize and reward effort
Resolve conflict constructively
Seek feedback
Strong understanding of compliance and quality standards
Very good understanding of ISO 9001:2000 and other Quality Certification applicable to Abbott Ireland
Good knowledge of all E.U. Regulations applicable to Abbott Ireland, Cootehill
Strong understanding of HACCP requirements and programmes

Quality Systems Senior Professional Resume Examples & Samples

Provides professional expertise and support for all Kimberly-Clark (K-C) manufacturing facilities, business teams, contractors, suppliers and functional teams to assist them in developing & implementing their Quality and Compliance strategies & plans
Leads quality and compliance improvement projects of moderate size and complexity or performs as a team member on a more complex project
Provides training in quality system development and compliance and in successful management of regulatory inspections to K-C units
Maintains state of the art knowledge in quality assurance, quality engineering and quality control as well as quality regulations for drugs, medical devices, personal protective equipment, consumer products and other K-C marketed product categories
Ability to successfully lead teams by positively influencing people at all organizational levels
Manage self in accordance with the expected behaviors of the Leadership Qualities
Ensures activities and items are in compliance with both company quality assurance standards and applicable government regulations, such as but not limited to EPA, GMPs, OSHA, and ISO requirements
Establish and maintain good customer rapport, while driving solutions to meet business needs
Develops, initiates, and implements new quality concepts, tools and strategies to improve business practices
Provides expertise guidance in specific field of knowledge
Assists with the transfer of knowledge of technical skills
Obtained a relevant auditor certification (i.e. Lead Quality Auditor, ASQ CQA, etc.) for the various and appropriate K-C product types (i.e. FDA regulated, Medical Devices, Cosmetics, PPE, Consumer Products, etc.)
Successful candidate would have relevant experience to lead organizations / cross functional teams through various types of FDA audits and FDA readiness programs
Minimum 5 years of experience in at least two related fields e.g. Manufacturing, Quality Control, Quality Assurance, Research, Process Validation, Regulatory Affairs or a closely related field
Successful candidate would have proven projects where specific tools and experience were implemented and led to significant process improvements or business impact
Minimum 5 years of experience in manufacturing of FDA regulated products where continuous improvement processes were implemented and consistently utilized to drive proven results
Minimum 5 years of experience in performing supplier qualification assessments, supplier quality management and supply chain management
Proven ability in leading cross functional teams in LEAN problem solving techniques and driving implementation of resolutions
Candidate would have proven experience with various advance problem solving techniques (i.e. DOE (design of experiments), ANOVA (Analysis of Variance), Six Sigma techniques, etc.)
Proven ability to work effectively with and influence business quality leaders. Develops and maintains strong networks across K-C with appropriate teams so that quality best practices can be developed, shared and implemented effectively
Strong verbal and written communication skills. The ability to communicate effectively to various audiences throughout all levels of the organization
Demonstrated ability to train, provide practical and actionable counsel and build capability in business partner teams
Minimum 5 years of experience in an FDA regulated Medical Devices or Pharmaceutical business or establishment
Fluency in a second language beyond English
An advanced technical degree in an engineering or scientific discipline or MBA

Quality Systems & Analytics Program Leader Resume Examples & Samples

Provide project leadership, expertise and counsel that result in the development and implementation of supplier management, standard practice management, and other quality and safety processes, capabilities, and tools for the Enterprise
Provide leadership and execution of the EtQ global rollout, development, and continuous improvement of Enterprise quality and EHS management processes
Proactively monitor compliance activity with EtQ Reliance and provide process health visibility to mitigate risk
Lead the development and implementation of major programs and initiatives associated with ensuring quality and regulatory requirements for diverse business needs and products are met throughout the world
Work with all business units to lead the identification, development, and implementation of analytics and reporting across all EtQ modules that drive improved decision making, profitability, speed to market, and compliance
Assist with the ongoing support, development, and improvement of core quality and safety management capabilities including, but not limited to Supplier Management, Clinical and Marketing Studies Management, Safety and Environmental Events, Product Safety Assessments, Best Practice Sharing, and Standard Practice Adoption
Provide functional direction to business teams in identifying appropriate tools and strategies to meet established quality, safety, and regulatory requirements
Ensure changes to existing quality processes meet customer and regulatory requirements
Interpret the requirements for specific businesses and support the implementation of strategies and systems to meet business objectives and requirements
Provide technical leadership and expertise to support large, complex facilities, facilities producing highly regulated products, and/or corporate staff teams
Lead and assist in the development of strategies and projects that improve business practices, and assure business, facility and corporate objectives and regulatory compliance requirements are met
Recommend, develop and support implementation of quality and regulatory policies, procedures, and systems
12 or more years broad experience in a Purchasing/Procurement, Quality Assurance, Information Technology, Continuous Improvement, or Audit function
EtQ Reliance – demonstrated proficiency and expertise
Close working relationships with business and manufacturing functions
Experience with cross functional project leadership
Process/System design, development, implementation, and improvement – demonstrated proficiency
Solid background of technical knowledge and experience combined with the proven ability to successfully direct projects and influence people at all organizational levels
Problem analysis – demonstrated proficiency
Exceptional written, verbal, and presentation communication skills
Team player with excellent organizational skills

Ingot Metallurgy & Quality Systems Supervisor Resume Examples & Samples

Leading the Ingot Metallurgy and Quality Systems group to ensure the material produced meets and exceeds customer, industry and Alcoa specifications through process control, practice development and inspection systems
Determining resource needs and obtaining technical support to drive continuous improvement efforts and stability
Giving customer technical support by specification review, consultation and on-site visits
Conducting internal audits to assess area of responsibility against standard requirements, correct non-conformities, identify best practices and opportunities for improvement
Establishing the requirements for raw materials verification and evaluating new raw materials. #LI-FS1
B.S. degree in Science from an accredited institution
Minimum of 3 years of experience in aluminum fabrication or metals industry
Minimum of 3 years of experience solving problems, understanding and applying metallurgical concepts, and reviewing standards and specifications
Minimum of 5 years of experience in aluminum fabrication or metals industry
Minimum of 5 years of experience solving problems, understanding and applying metallurgical concepts, and reviewing standards and specifications
Someone with Ingot casting experience

Quality Systems Leader Resume Examples & Samples

Supervises one or more Quality Systems Engineers
Establishing performance goals and conducts performance evaluations,
Coaches and trains direct report(s) in quality system requirements
Lead the location in preparing for 3rd party quality system registration audits and coordinate the closure of related non-conformances
Coordinate and lead the internal quality audit system
Plan, arrange and organize a periodic management review of the quality operating system
Provide quality systems related training including internal auditor training
Lead the location in preparing for customer audits and coordinate the closure of related non-conformances. Respond to and complete customer quality evaluation surveys
Administer the formal corrective action system
Act as the primary contact for response to customer requests for product compliance to requirements provided in legislation enacted by the U.S. Federal Government, Governments of U.S. States, the European Union or other relevant legislative bodies
Lead the location in the use and analysis of statistical methods such as control charts, capability studies, problem solving, Pareto Diagrams and other statistical tools for evaluating and reducing process variability
Support and provide technical assistance for the APQP Committee as well as in the development and maintenance of Process FMEA's and PPAP documentation
Maintain the Quality Manual and Quality System Procedures, and update as necessary to comply with the quality operating system
Administer the supplier quality system, including specification of quality critical goods and services, maintaining records of Approved Quality Critical Suppliers, conducting supplier audits and assessments and acting as the location contact for supplier corrective action requests
Bachelors of Science in engineering field from an accredited institution
Minimum of five years’ experience maintaining the Quality (ISO9001 or TS16949) standards for a manufacturing organization
Minimum 3 years experience auditing to the ISO9001 or TS16949 standard
ASQ Certified Quality Engineer (CQE)
Lean Six Sigma Black Belt certification
Experience leading APQP (advanced product quality planning) and performing FMEA (failure mode and effects analysis), PPAP (production part approval process), and SPC (statistical process control) as well as submitting documentation according to AIAG (automotive industry action group) guidelines
Experience leading an organization in maintaining ISO/IEC 17025 Accreditation
Aluminum rolling experience
Knowledge of statistical analysis programs (e.g. Minitab)
Must have strong communication skills and ability to communicate with all parties – customers, vendors, colleagues, superiors, etc
Experience with Measurement Systems Analysis
Certified RABQSA Quality Lead Auditor or ASQ Certified Quality Auditor (CQA)

Senior Analyst, Quality Systems Resume Examples & Samples

Supports implementation of compliant and effective Edwards TMVR Document Control system
Provides support with DCO process (processing of DCO/ECR/ECN)
Supports development and implementation of Edwards TMVR labeling processes
Supports development and implementation of Edwards TMVR training program and LMS implementation (training plan development, assignment, tracking and reporting)
Responsible for TMVR external regulatory standards management process
Interfaces with Manufacturing Operations, Engineering, Quality, Supply Chain, and other departments to resolve issues, and support key milestones for TMVR product labeling and TMVR training process
Creates regular reports on metrics as requested by management. Identifies opportunities for process improvement
Assists with Quality Management Review presentations
Lead and assist in CAPA investigation
Participate in external regulatory inspection activities. Assist in facilitating TMVR internal audits
Performs other tasks, responsibilities as assigned
A bachelor’s degree in quality, science, engineering, or related field is preferred. A combination of education, certification, and quality experience may be considered a substitute for a bachelor’s degree
A minimum of five (5) years of quality experience in a medical device company is strongly preferred. Will consider other highly regulated industries
Proficient understanding of quality systems, document control, training processes, labeling processes and medical device regulations
Strong verbal/written communication and organization skills along with good judgement skills within generally defined policies and practices
Ability to work independently with little or no supervision

Quality Systems & Audit Specialist Resume Examples & Samples

Coordinates new product launches and site transfers ensuring all documents and QA systems are in place for a quick release without any quality issues according to project timelines. Provides technical support for product divestment
Assist in managing the local review and implementation process for the Global Quality Manaul
Conducts quality issue investigations (deviations, out-of-specification results, complaints, re-calls, counterfeits, stability failures, etc.) according to the QAA and Novartis Quality Manual
Coordinate the handling, release, and distribution of pharmaceutical products are in compliance with the Novartis Pharma Corporate Quality Manual and Policies, the effective Quality Agreement that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs and Novartis KQIs
Ensure all Third Party Vendors audits are in place and included in the Global Auditing schedule. Acts as Auditor of Third Party Vendors, manage progress of audits in AQWA as QARP. Coordinate and conduct Self-Inspections annually
Ensures all Method Transfers are executed and completed in accordance with applicable stand-ards. Conduct Gap Assessment for Method Transfer requirements ensuring harmonization with Novartis Global Quality Modules
Manages risk assessments on external suppliers according to Global and Local Procedures
Manages QAAs by ensuring a valid Quality Agreement are in place and is in line with the global templates, clearly defining GMP roles and responsibilities between Novartis and external suppliers
Coordinate Inspection activities
Supports QA Manager in the implementation and maintenance of GMP quality systems and processes, in compliance with regulatory authorities, Novartis Standards, and all other applicable regulations
Act as deputy to the Quality Assurance Manager as Recall Coordinator
Acts as deputy for the Quality Assurance Manager in maintaining compliance of QA department
COMPULSORY: Associate shall be accountable to perform all duties listed in Role Profile in accordance with applicable GxP principles, and internal/external regulations (e.g. Novartis Code of Conduct, Novartis Pharma Principles and Practices for Professionals (NP4), Rx&D Code of Ethical Practices, Health Canada and all other relevant regulations)

Senior Quality Systems Supervisor Resume Examples & Samples

Serves as the primary quality resource for compliance and effectiveness throughout the plant and ensures adherence to all Mondelez Quality programs such as GMP’s, HACCP, Net Contents Internal Audits, Traceability & Recall, Hold & Release, etc
Provides leadership and technical assistance to help resolve quality related problems
Reviews and sets up new specifications and procedures used by manufacturing
Ensures materials conform to their specifications and deal with issues arising from non-conforming materials including hold and release of in process or finished goods
Reports deviations and inadequacies to the appropriate Manager
Audits quality systems & manufacturing practices and ensures that products are produced to specification and that all documentation requirements are consistently adhered to meet safety, quality, and regulatory requirements
Conducts investigations to determine root cause and recommends & implements corrective, preventive,or improvement actions associated with food safety and quality
Investigates consumer complaints & drives root cause to resolution
Supports the commercialization process within department/unit and provides technical expertise for Food Safety & Quality
Develop and conduct employee training as necessary to improve the overall quality management process & system
Bachelor’s Degree required (Science related field preferred)
2-3 years Food Manufacturing Experience
FSSC22000/BRC auditing/ISO 9001 experience
Six Sigma Green certified
Computer Skills (Excel, Word, Power Point, Access)
Experience in creating, implementing, maintaining, evaluating, enforcing and updating a facility’s GMPs, HACCP, SSOP and SOP’s and Quality programs

VP, Quality Systems Resume Examples & Samples

Bachelor’s degree required in a biology, chemistry, engineering or related field
Twenty or more years of experience in medical device quality operations, quality assurance, quality systems, and/or compliance role (less years of experience considered with advanced degree); experience with a molecular diagnostic company preferred
In addition to quality systems experience, experience in operations, manufacturing, and/or R&D preferred
Demonstrated ability to work as a senior leader and to engage the entire senior leadership team as needed
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
Demonstrated excellence in written and verbal communication
Demonstrated ability to work cross-culturally and to develop and maintain strong business partner relationships
Demonstrated ability to work effectively with US FDA and other regulatory agencies
Track record of measureable, operational improvements to Quality Systems related functions
Substantial knowledge of QSR, GMP, FDA, ISO, and other medical device regulations
Extremely detail oriented with strong organizational skills, and high quality standards
Strong computer skills, including outstanding skills in grammar, punctuation, and spelling
Exceptionally strong team player with excellent interpersonal and communication skills
Experience working with end-users in coaching, mentoring and motivating capacities
A proven track record as a successful and decisive leader in a strategic, multi-functional, matrixed and global environment
Management of complex projects with ambitious milestones in high pressure circumstances
Understanding of P&L management with strong financial and analytical skills
Strong team building skills to ensure cross functional effectiveness, strategy development, high level of department contributions, and overall strong performing team
Clinical laboratory experience, including hands-on experience running PCR-based research or clinical assays
LEAN or Six Sigma operational excellence training or certification

Director of Quality Systems Resume Examples & Samples

Accountable for the operations, results, and continuous improvement of the Adaptive Quality System
Develop and implement quality policies and procedures to ensure compliance with local and global regulations
Analyze and continually improve the quality process. Assist in the development of department operating plans
Ensure timely, efficient and effective execution of work assignments and maintain conformance to established quality expectations
Strengthen quality assurance’s infrastructure through education, training, performance based appraisals, and recruiting
Establish and monitor specific individual goals and objectives

Senior Specialist, Quality Systems Resume Examples & Samples

Assists in the formulation, development, and implementation of consistent training plans for new hire training, on-the-job training and compliance in conjunction with departments/functions
System Administrator for the Fremont LMS responsible for coordinating access to the LMS for employees and external resources. Ensures the proper documentation of training in Learning Management System (LMS)
Partners with HR team to coordinate and deliver New Hire training
Implements and maintains BI Fremont Quality Systems. Engages Network to ensure alignment with Corporate/Global BioPharma sites and operating units. Represents process during internal/corporate client audits and health authority inspections
Key User/Point of Contact for Quality Systems. Provides process and system training for site staff involved with the Quality System process
Leads or is involved in BPE/BIOS projects
Supports Deviation/CAPA/Investigations Process Owner
Site SME and Support role for Quality System related activities
Supports inspection readiness activities and fills inspection execution roles
Supports Quality Risk Management Process Owner by facilitating risk assessments and incorporating Risk Management principles into Quality Systems, as needed
Leads/Participates in cross-functional investigations or assessments in support of investigations, change controls, or other compliance activities

Learning Specialist, Quality Systems Resume Examples & Samples

Responsible for administering and maintaining the training assignment by dis-positioning requests and assisting SMEs with BSD/QSD related training requests
Assist in the analysis, design, development, implementation, and evaluation for specific learning programs
Responds with a high level of customer service to training questions and requests
Build proficiency in the utilization of the learning analytics tool to analyze the effectiveness of training programs. Assist in the reporting of metrics and scorecard dashboards
Assist in SLMS related tasks by providing support to Learning Advisors, Process Owners and managers with user group and curricula assignments
Provide support during audits, internal and external
Assist in the organization wide annual learning needs analysis process
Works with managers to ensure that employees receive appropriate and required assignments in accordance with quality system regulations. This includes ongoing establishment and evaluation of curricula and user groups in our learning management system (LMS) and on-boarding plans as appropriate
May teach specific training courses
Assist in the creation and maintenance of competency based training
Perform additional duties and projects as assigned
0-2 years relevant experience in adult education, learning and development, or related fields preferred
Demonstrated experience of adult learning, instructional design, e-learning and training methodologies
Demonstrated understanding of a notified body/ government regulated training environment
Bachelor’s Degree required with preferred focus in Organizational Development, Training and Development, Education, or related field

Senior Specialist, Quality Systems Resume Examples & Samples

Facilitate and leads risk assessments and incorporate Risk Management principles into Quality Systems, as needed
Use ICH Q9 / ISO 14971 principles and risk management methods/tools for risk assessments (e.g. FMEA, Fault Tree Analysis)
Leads or is involved in Business Process Excellence

VP Quality & Systems Improvement Resume Examples & Samples

Assumes full responsibility for developing and implementing regional strategic direction for the SWA Quality and Systems Improvement team of 15 Quality Systems Improvement/Mission: Lifeline staff and administrative team members
Annually reviews and adjust affiliate Quality and Systems Improvement plan while developing stakeholder relationships to assist with the accomplishment of those plans
Identifies opportunities and leads teams to execute on demonstration projects related to healthcare quality, working via alliances and vendors/partners, as appropriate
Creates customized initiatives to meet needs of targeted audiences
Develops transformational relationships to help advance the AHA mission through involvement in cultivation, securing and stewarding relationships towards extraordinary results including acquiring large health systems to be engaged in AHA programs focused on improving the cardiovascular health in affiliate communities
Provides leadership over a diverse and dynamic affiliate team to ensure the AHA carries out its mission while driving positive employee engagement. Includes setting integrated goals, developing staff performance standards and holding staff accountable for meeting individual goals, which contribute to the overall team goals, department goals and AHA goals. Coaches and counsels staff on business methodologies/practices and organizational protocols ensuring the highest level of ethics are adhered. Interviews, selects and trains new direct reports. Evaluates performance of direct reports based on performance standards and team goals and priorities while providing direction and gaining commitment
Ability to effectively plan and manage workflow, work on multiple projects simultaneously and manage project details with limited supervision
Strong written and verbal communication including negotiation, interpersonal and ability to effectively communicate AHA policies, guidelines and strategic direction to volunteers and staff
Proven ability to conduct meetings with internal and external clients including interacting with external partners/sponsors representing AHA to the public as necessary
Demonstrated ability to simultaneously manage multiple, large and complex projects/events in varying stages of development under time constraints
Demonstrated ability to productively participate in a multi-disciplinary team environment working toward common goals with internal and external clients
Ability to effectively lead and develop a team with positive employee engagement
Ability to travel up to 80% of time throughout the affiliate including overnight travel and attendance at occasional meetings and events taking place on evenings/weekends including outdoor events
Minimum of three years of management experience or in progressively responsible positions

Quality Systems Operator, External Partners Resume Examples & Samples

Manage non-conforming product inventory and traceability for product manufactured and co-packed at the external manufacturing sites
Ensure timely disposition of hold product (sampling, destruction, release, donation)
Participate in annual business unit (BU) trace and support retrieval exercise
Assure non-conforming product inventory management through monitoring of Vehicle Load Management System (VLM) and SAP transactions
Key user of Atlas outbound including report generation and knowledge of inbound system
Reporting and trending of Product Related Incident Management Process (PRIMPs) and non-conforming product
Effectively maintains ISO document control and ensures that the documentation and records are readily retrievable
Manage ISO documents for Hold Management, Document control, Record retention and traceability (define and update documents needed for ISO)
Lead and manage the external manufacturing product verification program
Partners with External Manufacturing Supply team, Logistics and R&D and other key stakeholders to implement changes such as new process or procedures to ensure non-conforming product, traceability and document control are working effectively and efficiently
Provides technical expertise in Nexus system to key users as it relates to document control and non-conformances
High school diploma
Understanding of ISO9001 standards
Associate’s or Bachelor’s Degree in science based curriculum
3+ years of experience in a manufacturing setting
Competence in Nexus, Atlas or another technical data software
Understanding of FSSC 22000 standards

Associate Director Medical Devices Combination Products Change Control Quality Systems Improvement Program Resume Examples & Samples

Supports maintenance, knowledge transfer, and as needed development of Merck’s Device specific Quality Management System
Participates on Merck teams supporting MDCP CGMP and quality issues related to pure medical devices and the device constituent of a combination product
Works with the External and Internal Partners to ensure that effective and robust MDCP Quality Systems and Quality management are in place
Provides guidance in the preparation of metrics, procedures and guidelines
Provides proactive support in training and coaching to initiate quality improvements within Development, Operations and Quality
Audits and approves Design Control and Device Risk Management GMP documentation for applicable regulatory filings, clinical supply, development and design transfer qualification. Ensure compliance with regulatory and Merck requirements. Evaluate deficiencies and assess impact on compliance status
Contributes to developing/revising policy and procedures for MDCP Quality and /or supported areas
Supports preparations for regulatory agency inspections with focus on relevant MDCP regulations and Quality system requirements
Remains informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards. Maintains an expert level of knowledge related to a specialized area of expertise
Expert knowledge of medical device regulations and compliance in a specialized area with experience in their application, including current GMPs for combination products
Demonstrated ability to work effectively in teams
Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others
Effective written and oral communicator
Able to speak up and contribute in a team forum. Able to apply prior experiences and learnings in new settings, even if these are unfamiliar
Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset

Quality Systems Compliance Specialist Resume Examples & Samples

Responsible for ensuring compliance of local implementation of Quality Systems with all local, national, international and company regulations, policies and procedures
Administers the Document Change Process, includes assigning tracking numbers in accordance with corporate field support, issuing appropriate documentation, tracking document status and making documents effective upon completion of training requirements, as required
Work effectively with the other departments and site compliance specialists to ensure consistent systems
Stays current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)
Participate in quality and process improvement initiatives, and project teams
Coordinates area training
Manages the day-to-day aspects of the Archival process, which includes record retention, obsolescence, and archival
Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections. Maintain audit schedules and client communication
3+ years experience
Mastery of Microsoft Word is required
Knowledge of FDA GLP/ cGMP requirements is required

Lead GMP Auditor Quality Systems & Compliance Resume Examples & Samples

Minimum 10 years of experience in bio/pharmaceuticals environment with at least 7 years in Quality Assurance
Up to 20% travel (domestic and international)
Must have a technical background and a thorough understanding of the vendor qualification and auditing process
Must have extensive knowledge of worldwide requirements related to GMP regulations for quality systems and compliance (FDA, EU, ICH guidelines and industry best practices)
Must have excellent oral/written communications skills and attention to detail
Must be able to identify issues and offer solutions in a pragmatic way
Must have excellent business skills like critical thinking, strategic planning, and self-management
Personal skills needed include interpersonal skills, leadership, tact, open-mindedness, maturity, decisiveness, self-reliance, organizational/administrative skills and sound judgment
Effective collaboration skills are essential with an ability to work effectively outside of the company and across divisional and technical areas
Accreditations or Certifications preferred
Advanced degree is a plus

SQO Quality Systems Project Specialist TPW Contractor Years Resume Examples & Samples

Minimum four (4) year Bachelor’s Degree in Science, Engineering or related discipline
Minimum of two (2) to five (5) years of previous relevant experience of quality in a pharmaceutical or biotech industry
Experience and knowledge of document management in the pharmaceutical / biotech industry preferred
Experience with continuous improvement methodologies or managing projects in the pharmaceutical /biotech industry preferred
Thorough knowledge of cGMPs and regulatory requirements
Demonstrated ability to work independently and make quick decisions in accordance with SOPs and training
Ability to communicate and work with a broad spectrum of professional and technical staff to effectively manage documents, records and the document lifecycle process in an efficient and practical manner
Good communication (written / oral), problem solving, organizational, and facilitation skills
Strong customer focus and ability to prioritize and adapt to business needs
Ability to analyze data, effectively summarize findings and draw conclusions

Quality Systems Lead / Associate Director Resume Examples & Samples

People Management of a group of about 10-15 employees
Ensuring GMP compliance for Biotech Operations by managing the following topics
Master’s or Bachelor’s Degree or similar level by working experience (e.g. Biology, Biotechnology or Bioprocessing)
At least ten years of experience in relevant and managerial experience (of which at least 3 years in a Quality department)
Proven good track record with regulatory inspections and customer audits
Thorough knowledge and experience in interpreting current regulatory requirements (e.g. FDA, EU, Canada, Japan, Brazil) as they apply to a biologics manufacturing operation
Proven compliance mindset and experience with implementing Quality Systems
Broad knowledge of manufacturing and/ or analysis processes
Demonstrated excellent interpersonal skills with the ability to influence, motivate, and lead teams
Able to carry out and implement a quality mindset within the Biotech Site
Strong project management skills & proven ability to manage complex projects
Excellent oral and written communication skills in English (Dutch is a plus)

Principal Quality Systems Compliance Engineer Resume Examples & Samples

7+ years experience in Quality Assurance, including Quality systems, standards, metrics, and tools
7+ years of experience in the medical device industry
Mastery of medical device quality systems and applications is required
4+ years of Auditing experience to the 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR and the Medical Device Directive
4+ years of experience with Risk Manangement, ISO 14971, FTA, Design FMEA
4+ years of experience with comparative statistical techniques & sampling plans
Familiar with IEC 60601 and product specific industry standardsAbility to effectively influence and negotiate with all levels of an organization and leading effective/successful change initiatives
Self- starter, with the ability to work independently and with all levels of managers, associates, and clients
ASQ CQE, CQA, CSQE and/or CRE certification
Physical requirements
Normal Office Conditions. Must be able to operate a computer and a telephone. May need to work in a bench setting, lab setting, manufacturing floor, or clean room environment
Must be able to travel by car and plane (less than 10%)

Senior Quality Systems Compliance Engineer Resume Examples & Samples

5+ years experience in Quality Assurance, including Quality systems, standards, metrics, and tools
5+ years of experience in the medical device industry
2+ years of Auditing experience to the 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR and the Medical Device Directive
Training in CAPA compliance & Investigation techniques
2+ years of experience with Risk Manangement, ISO 14971, FTA, Design FMEA
2+ years of experience with comparative statistical techniques & sampling plans
Familiar with statistical software tools (Minitab, Stat Graphics, Statistica)
DFSS / Lean Green Belt or Black Belt

QA Senior Quality Systems Spec Shanghai Resume Examples & Samples

3 Strong CAPA and audit ability
4 Solid understanding on ISO13485
5 Medical, pharmaceutical background
6 Good knowledge of SPC (Statistics Process Control)
7 Min. 5 years of experience with a foreign multinational company
8 Quality experience in medical device, pharmaceuticals or electronics
9 Familiar with R&D and/or manufacturing control
10 Prefer Software control experience

Quality Systems Supervisor Resume Examples & Samples

Bachelor of Science degree in Quality engineering or related field or 5 years experience
Must demonstrate leadership skills or potential
Familiarity with Quality Systems Regulations
Familiarity with Quality Systems Regulations and ISO 13485 standard

Quality Systems Operator Resume Examples & Samples

Manage non-conforming product inventory and traceability for product manufactured and co-packed at the site
Conduct annual site trace and support retrieval exercise
Assure non-conforming product inventory management through monitoring of VLM and SAP transactions
Key user for the Nexus system
Reporting and trending of PRIMPs and non-conforming product
Effectively maintains ISO document control and ensures that the documentation is readily retrievable
Drive continuous improvement in Quality systems (Hold Management, traceability and ISO systems)
Develop and deliver training on Hold Management and traceability programs and best practices
Manage ISO documents for Hold Management, Document control and traceability (define and update documents needed for ISO)
Work with others to improve processes and systems through innovation, effective change control, research, and auditing
Maintain inventory of MLP code date stamps according to the corporate code date calendar
Conduct internal ISO audits
Participate in the site sensory program
Responsible for ensuring incoming materials are properly sampled at required frequency
Conduct testing on incoming materials
Partners with Site Supply team, Logistics and R&D and other key stakeholders to implement changes such as new process or procedures to ensure non-conforming product, traceability and document control are working effectively and efficiently
Provides technical expertise in Nexus system to key users as it relates to document control and non-conformance
2 years of experience in a manufacturing setting
Excellent communication & documentation skills
Competence in SAP Systems
Successful Completion of a drug and background screen

Head of Quality Systems Extl Biologics Resume Examples & Samples

10+ years experience working in a Quality Systems role in the pharmaceutical industry
Experience in the biotechnology and/or pharmaceutical industry, preferably both and diverse experience for eg experience in manufacturing/operations
Experience with Aseptic/ Sterile Processing and Packaging and labelling
Proven people manager and leader capable of developing people and teams with at least 10 years of management experience

Quality Systems Documentation System Administration Specialist Resume Examples & Samples

B.S. in sciences, engineering or equivalent
Requires a minimum of 3 years previous experience working in a cGMP/GXP environment
Previous System Administration experience in a GxP environment
Has knowledge of practical applications of Records and Document Management with a broad understanding of 21 CFR parts 210 & 211 Parts 4, 11 and 820 and EU regulations
High level of proficiency with MS Office, including Word, Excel and Power Point and ability to learn new systems
Highly organized and detail oriented
Knowledge of continuous improvement principles and practices such as six sigma methodologies to include process mapping and evaluation preferred
System Administration experiences in a Document Management System
MasterControl experience

Quality Systems Administration Engineer Resume Examples & Samples

Highly motivated, self-directed leadership with minimal management guidance
Demonstrated problem-solving and audit skills
In-depth understanding of Quality Systems and principles
Proven application of PDCA concept (Plan, Do, Check & Act)
Project management & team facilitation · Superior written and verbal communication skills
Ability to communicate with upper and senior level management and present / create executive level presentations
PC Skills: Microsoft Excel, PowerPoint, Word, Access
Bachelor’s degree related to engineering. 4 or more years of directly related engineering experience
Travel Requirements: 25~ 50%, occasionally international

Quality Systems Lead / Associate Director Resume Examples & Samples

University or Bachelor Degree or similar level by working experience (e.g. Biology, Biotechnology or Bioprocessing)
Broad knowledge of manufacturing and/or analysis processes
Demonstrate excellent interpersonal skills with the ability to influence, motivate and lead teams
Excellent oral and written communication skills in English (Dutch is a strong plus)

Quality Systems Coordinator Resume Examples & Samples

Prepares written documents describing analysis techniques and test results. Writes and reviews SOP’s and other quality documents and reports
Communicates, written and verbal, with all levels of the organization in review of test results
Provides support for sample gathering and data recording for plant trials, 1100’s and research efforts
Performs audits to verify compliance with established SOP documentation, GMP’s and Safe Quality Food (SQF) efforts
Assists with audits (i.e. SQF, regulatory, customer, internal)
Assists with the coordination, performance, and documentation remediation of product on hold (i.e. updates database, tapes rows, places placards)
Reviews regulatory documentation for product release (i.e. record review) including CCP/critical factor records, QA packaging records, and net weight records per lot
Conduct GMP and sanitation audits
Participates and leads process improvement projects
Participates and leads quality meetings and training
Supports CPS activities
Supports the assessment and management of Food Safety Plans -Hazard Analysis of Critical Control Points (HACCP) or (HARPC)
Determines usage decisions on bulk and regular ingredient deliveries
Monitors and reviews SPC data and reports
Support cross checks program (solids, pH, TA)
Assists with critical consumer complaint investigation
Maintains retain program
Assist in trouble-shooting quality related issues
Performs record reviews
Provides back-up for the Supplier Quality Specialist
Associate’s or Bachelor’s degree in biology, chemistry, microbiology or lab science, preferred
2 years microbiological lab experience preferred
Knowledge of Good Manufacturing Practices (GMP’s), SQF and HACCP/HARPC
Self-motivated. Able to work independently with minimal supervision
Ability to manage multiple projects/tasks simultaneously
Naturally curious
Ability to think ahead and plan over an extended time period and prepare action plans to achieve results
Knowledge of aseptic (laboratory) methods, measures, and practices
Understanding technical vendor manuals and Standard Operating Procedures (SOP’s)
Knowledge of instrumentation (temperature, pressure, etc.)
Experience in leading root cause analysis activities
Knowledge of TPM, Six Sigma and Lean Manufacturing techniques
Knowledge of FDA and USDA policies and procedures

Quality Systems Associate Resume Examples & Samples

Serve as the Management Review local process owner for the BioLife HQ entity: coordinating with all other BioLife entities, collecting data, coaching, scheduling and facilitating meetings
Serve as the GEMS local process owner for the BioLife HQ entity: coordinating with all other BioLife entities, monitoring adequate resource availability by user role, perform classroom training, monitoring and delivering metrics, monitoring of record execution (coaching as needed), owning events for internal and external deviations
Serve as the contract review process owner and facilitator
Support plasma logistics and transportation: providing quality oversight for transportation and storage suppliers: coordinating with centers, HQ, consignees and transportation suppliers to ensure successful transfer of plasma from the center to the consignee
Support inspection and audit readiness: maintaining the inspection/audit readiness plan for BioLife HQ, training and coaching inspection/audit support staff, provide inspection/audit support as needed
Experience with plasma regulations and distribution
Validation experience for shipping lanes and cold chain distribution

Quality Systems Compliance Manager Resume Examples & Samples

Lead site specific audit readiness activities
Provide audit results to management and coordinate audit CAPA/OBS actions
Direct and/or conduct investigations into potential quality/compliance concerns. Keep management informed of issues
Stay current on applicable FDA, ISO (including risk management), and other applicable industry requirements. Monitor external publication sources for issues applicable to DePuy Synthes
Provide consulting service to site and corporate personnel
Promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities
Minimum of 8 years quality/compliance experience in the medical device and/or pharmaceutical/highly regulated Healthcare industry
A minimum of 3 years’ experience directly performing audits in the medical device and/or pharmaceutical/ highly regulated Healthcare industry is required
Experience working with Manufacturing, Product Development and Corporate functions is preferred
This position will be based in Palm Beach Gardens, FLA and requires up to 15% travel

GCA Quality Systems Senior Engineer Resume Examples & Samples

Subject matter expert for GM China for GCA audit standards, equipment and processes (resource to JV Central Quality team and JV plant GCA audit teams)
Coach and train China JV vehicle assembly plant quality audit departments on audit standards and processes
Conduct periodic monitoring and courtesy GCA audits of in plant JV audit teams to assess conformance to global GM standards and practices for audits. Identify issues and help JV plants to make corrections
Conduct new program GCA training and calibrating to support China JV plants in detecting quality issues early
Conduct competitive audits for benchmarking and Target setting
Support China JV plants Port of Exit/Entry audits and in plant launch support audits
Produce, deliver and maintain audit records
Participate in Global GCA Team meetings and workshops
Support China JV GCA teams’ communication with Global GCA Team
Conduct Cross Region GCA Monitoring Audits
Support China JV Functional teams (SMTs, Program Quality, Design Studios, Supplier Quality and other stake holders) understanding of GCA standards and processes. Provide training as needed
Strong GCA standards and process understanding preferred
Knowledge of Vehicle Assembly Manufacturing preferred
Good knowledge and experience with MS Office software - Excel, Word, Powerpoint, Outlook and SharePoint. Required
Good driving skill, more than 3 years actual driving experience. Required
Good English (written/speaking) preferred
Good written communications
Experience in OEM Manufacturing/Quality field preferred
Experience in vehicle quality auditing preferred
Ability to interact with and support China JV plant personnel and plant leadership required
Experience working on quality/engineering initiatives and process execution preferred
Bachelor degree or equivalent experience required. Major in engineering and Auto manufacturing is preferred
Familiar with Assembly Manufacturing process preferred
Familiar with the elements of the Global Manufacturing System (GMS) preferred
Familiar with Vehicle development process (GVDP) preferred
Familiar with problem solving process required
Ability to coach, teach and audit elements of standardized manual required
Managerial Courage and confidence to provide direct, honest, constructive feedback to China JV Plant Auditors / China JV Plant Staffs / China JV and GM China Executive Leadership
Willingness to travel minimum of two weeks per month

Quality Systems Coordinator Resume Examples & Samples

Assist with identifying and collating the data necessary to help determine and benchmark the cost of defects to the business
Assist and positively encourage site teams to record amounts of time and money spent rectifying defects on site
Assist with initiating Purchase Orders for external audit assessments, and for the authorising of resulting invoices
Assist with the development and administration of an internal cross audit system with volunteer auditors
Assist in the organising and conducting of quality systems training for colleagues, as required
Ensure all colleagues have access to suitable quality information, guidance and support
Assist with the local Business Unit role out of the new Group Assurance System
Assist in the management of the company’s audit programme, including the planning and organising of internal audits
Conduct audits and monitor conformance with the company management system
Monitor the closing out of audit findings (Observations, NCRs) through the company Issues Register, and escalate items that become overdue
Assist in the update and maintenance of the company management system
Assist in the preparation of quality reports as required by the business
Monitor, manage and report on Quality related KPIs
Assist in the monitoring of project archiving to ensure this is being completed by the project teams
Support the Business Development team in the producing quality statements in support of PQQs and tenders
Assist Project Teams in the preparation of Project Quality Plans, as required
Deliver QA inductions / training to new staff, as required
Comply with Kier Group's SHE policy and procedures, all legal requirements and best practice
Experience in a similar or supporting post
Experience working with Quality Management Systems
Working knowledge of ISO:9001
Good oral and written communicator
Ability to work as part of a team and to positively influence others
Ability to work on own initiative, deliver key objectives while working under pressure and coping with stressful situations

Senior Director of Healthcare Quality & Systems Improvement Resume Examples & Samples

Strategically plan and manage hospital outreach to drive customer engagement, increased QSI contracts and progression of hospital and EMS awards and recognition within the market or region in SWA
Run regional data reports to share healthcare provider and patient data in a region
Manage volunteer engagement monitoring and volunteer training activities
Manage SWA content and lead planning strategy to leverage all QSI marketing publications, including US News & World Reports, online mapping, and recognition events for healthcare providers in the market or region
Work with Marketing & Communications to establish annual community values QSI information
Work with Award winning hospitals on promotional and communication opportunities
Experience Implementing Get With The Guidelines® or Mission: Lifeline® in a hospital setting
Experience working with healthcare providers on health information technology or clinical quality measures
Experience managing a remote team
Bachelor’s degree from an accredited four-year college or university with major course work in a field relevant to assignment, preferred. 5-7 years experience and education may be substituted for one another. Master’s degree in an above-mentioned area is a plus
Experience in project management that demonstrates the ability to manage multiple concurrent projects independently and complete projects thoroughly, timely and within budget
Demonstrated ability to gain collaboration of internal and external stakeholders in achievement of identified goals
Knowledge of the federal and state legislative process and state government administration
Knowledge of leadership principles
Skill in understanding group and individual dynamics
Skill in negotiations
Skill in persuasion
Skill in motivating others
Skill in coalition management
Skill in project management
Database or health registry experience
Skill in compiling, evaluating, and presenting health quality information, in problem-solving and negotiating, and in data reporting and analysis
Ability to work evenings/weekends and travel when necessary
Ability to participate in meetings, work in a team environment and interact with all levels of AHA staff, volunteers and public

Quality Systems Supervisor Resume Examples & Samples

Oversee the development, implementation, review and maintenance of the current GFSI program
Take appropriate action to maintain the integrity of the current GFSI system
Responsible for verifying and validating changes to food safety and food quality plans that have an impact on the acceptability of food prior to release
Maintains SQF Documentation – Policies, Procedures, Work Instructions, Forms, Training, etc
Will serve as HACCP Coordinator (must have HACCP certification)
Coordinate annual HACCP Review
Participate in 3rd party audits
Participate in daily sensory panel
Leads Change Management Team/Organizes Team Meetings
Responsible for managing training needs of departments
Complete/Track CAPA items
Issue Internal Quality Audits
Review completed Internal Quality Audits and follow through with corrective/preventive actions when necessary
General support of plant production and quality assigned by plant leadership
Attend all safety meetings, report any safety incidents/accidents and understand and follow all Company and Plant Safety policies and Procedures
Supervision of employees may be required on occasion but not as a part of a regular work assignment

Quality Systems Leader Resume Examples & Samples

Bachelor’s degree in a science, engineering or related discipline
Lead Auditor Certification Required
Bi-lingual Spanish Required
5 years of experience in the medical device industry in Research & Development / Manufacturing / Quality / Regulatory Affairs, including a working knowledge of FDA QSR, Canadian CMDR, MDD 93/42/EEC, and ISO 13485 standards and regulations Required
Travel 10-25% Required

Compliance & Quality Systems Lead Resume Examples & Samples

Ensure that all aspects of the handling, manufacturing and distribution of Biopharmaceutical Drug Substance (DS) at the site comply with the requirements of the Novartis corporate quality manual and policies, and meet all relevant cGMP regulatory and legislative requirements
Manage the implementation of Novartis Policies (Novartis Quality Manual) to ensure quality processes are maintained and current
Resolve critical complaints, recalls, counterfeits and product tampering according to the Novartis corporate quality manual and support / participate in NEM cases as required
Sustain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the whole site
Ensure that coordinated contact is maintained with the regulatory authorities and the local partners (suppliers, third parties, licensees, distributors)
Audit, supervise and co-ordinate third party activities and ensure that Biopharmaceutical manufacturing, testing, storage and/or distribution of Novartis products is in compliance with Novartis standards
Manage quality agreements for contract manufacturers, critical raw material vendors and contract laboratories
Act as a role model in accordance with the Novartis Values and Behaviours and the leadership standards

Senior Quality Systems Spec Resume Examples & Samples

Bachelors degree required (Engineering, Quality/Regulatory or Life sciences preferred)
4+ years of previous experience in a quality assurance or quality control environment within a medical device, pharmaceutical or related company with Bachelors
2+ years of previous experience in a quality assurance or quality control environment within a medical device, pharmaceutical or related company with a Masters
Familiarity with Root Cause Analysis methodology
Knowledge of US and international medical device quality system regulations and standards (21 CFR 820, ISO 13485)
5+ years of previous experience in a quality assurance or quality control environment within a medical device, pharmaceutical or related company with Bachelors
3+ years of previous experience in a quality assurance or quality control environment within a medical device, pharmaceutical or related company with Masters

Quality Systems Director Resume Examples & Samples

Knowledge of purchasing, supplier management, and supplier quality processes
Skilled leading cross-functional teams or working individual
Skills in personal computer spreadsheet, word processor, and engineering tools
Ability to carry out engineering calculations and analysis
Ability to write engineering documents, test protocols, laboratory notebook entries and reports

AP Quality Systems & Compliance Lead Resume Examples & Samples

Responsible for leading key strategic compliance projects on behalf of AP SM LOB Quality (QRP, Serialisation, QSIP workstream) and representing SM AP Quality in global and regional forums
Ensure alignment of Regional manufacturing sites with divisional quality systems and compliance with agency expectations
Act as the primary liaison for the AP SM LOB for complex compliance issues such as Significant investigations, agency response development and coach sites quality teams to build site Quality capability
Support effective fact finding process to ensure that quality defects that have the potential to result in market action of health authority notifications are completed in a timely manner, with coherent root cause investigation, clear recommendations on HA notification and convening the recall committee
Support proactive regulatory intelligence collaborating with global and Regional sites
Proactively sharing and learning from internal and external audits to Quality Site heads
Lead Quality councils for their region and monitor and measure effectiveness
Bachelors Degree in a relevant discipline; post graduate qualifications well regarded or experience in lieu
Minimum of 10 years’ experience in roles of increasing responsibility in the pharmaceutical industry
Minimum of 5 years relevant experience in Quality Management
Excellent organisational and presentation skills; strong business acumen; ability to work across organisational boundaries
Demonstrated Strategic focus is preferred

QC Quality Systems Technical Lead Resume Examples & Samples

Supporting the following Quality Systems
Change control
Investigations
CAPA’s
Owning, managing the process from start to approval of QC related investigations and change controls. Ensuring the timely completion of all activities related to these systems
Developing, implementing and managing procedures and quality system elements to ensure compliance of all QC activities to all applicable policies, directives, guidance documents and regulatory expectations
Supporting the QC Lab through global regulatory agency inspections
A degree in science or related discipline is essential along with 5 years’ experience in the biopharmaceutical industry, preferably in Quality. A minimum of 3 years’ experience with demonstrated effectiveness using quality systems in a FDA and EMA regulated environment. Knowledge of biotech QC testing is desirable
The candidate will have demonstrated proficiency communicating and collaborating at a variety of levels. In addition, the candidate will have proven success working well in a team environment with flexibility to react to changing business needs, as well as demonstrated problem solving and project management ability

Director, West Point Quality Systems Resume Examples & Samples

Coordinates and directs teams of multi-disciplined professionals in areas of process and systems, as they relate to quality system enhancements
Oversees the execution, robustness and performance improvement of a subset of key Quality Systems, that could include
Uses available information channels to maintain compliance proficiency, and utilizes this information to identify and evaluate emerging trends for incorporation to Quality Systems requirements. These information channels include
Responsible for hiring and ensuring Quality Assurance personnel are trained, and administers all personnel policies and development programs. Ensures personnel operate within established policies/procedures of Merck and in compliance with cGMPs and all applicable governing regulations
Utilizes personnel capacity in an efficient manner to ensure on-time output of customer needs
Bachelor's degree in an appropriate scientific or engineering field of study is required
Preferred fields of study include Biology, Biochemistry, and Microbiology. An MBA or other business degree, in addition to the required science or engineering education, is a plus
Strong understanding of cGMPs, FDA and EMEA regulatory standards. Strong compliance mindset
Experience in compliance remediation activities at plant sites
Experience and/or exposure in Plant audits and Supplier Audits
Experience in Regulatory Commitments implementation and effectiveness
Minimum of two (2) different management pathway roles or experiences
Previous exposure to documents approval such as: Validation reports, Nonconformance investigations, Work orders and Change controls

Director West Point Quality Systems Improvement Program Lead Resume Examples & Samples

Ensure QSIP is effectively deployed and installed at the West Point Site according to schedule. Evaluate ability of site to maintain level of compliance. Evaluate requests for variances and/or requests for variance extensions. Confirm closure of remediation activities according to plan, inclusive of approved variances
Represent West Point Site on the Divisional QSIP deployment team. Collaborate to ensure the right initiatives are deployed to enable the Site to realize the maximum benefit as quickly as possible in the overall implementation strategy
Partner with the Site Quality Leaders and Site Operations Leaders in areas of compliance to proactively identify initiatives and Quality System enhancements. Serve in the role of coach and mentor to develop future compliance leaders in the LOB. Identify areas of continuous improvement for simple lean Quality system deployment (MPS/KATA) and ensure best practice sharing to drive improvement across the sites. Champion various compliance initiatives according to LOB/MMD priorities, as directed
Support and contribute to internal and external compliance forums to identify and evaluate emerging trends for continuous improvements related to Quality Systems requirements. This includes serving as a conduit of information to the Divisional Quality System Improvement Leaders to support creation and installation ofproper Quality Manual guidance. QSC to sites
Evaluate the performance and support QMS installation to enable monitoring and improvement of key Quality Systems and Quality Assurance programs across the Site and builds improved sub-sytem ownership capability, knowledge sharing and ability to improve Site compliance
Monitors Sub-system health and proactively identifies, investigates and resolves trends and patterns before they impact compliance and supply. Leads development and execution of significant innovative projects that drive operational improvements within the Sub-system as per the drivers of KPIs as identified by LOB/MMD including but not limited to
At least eight (8) years of work experience in a medical device, pharmaceutical, biologic and/or vaccine manufacturing environment or a strongly related, similarly regulated field
Concurrently, four (4) years of managerial experience, with responsibility for direct and indirect reports
Strong lean mindset with MPS/Kata capabilities
Ability to be self-motivated and work independently, yet collaboratively in team settings and within matrix organizations to achieve objectives
Highly experienced in listening to and gathering a range of perspectives and with ability to develop solutions and champion a position
Previous work within Sterile/Vaccines manufacturing companies or regulatory authorities
Accountable for actions, drives results, and learns from mistakes
Demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions
Communicates influences and escalates issues and decisions, as appropriate
Goes to the shop floor to see the problems and work directly with people on the shop floor
Demonstrates tolerance for ambiguity
Experience in CAPAs effectiveness and Implementation

Assoc Dir, Quality Systems & Compliance Resume Examples & Samples

Bachelor Degree in Engineering, Biological, or Chemistry Sciences
Minimum of 8 years of manufacturing, technology, and/or quality operation experience within an FDA, and/or EU API, Drug Product, Medical Device or equivalent environment
Quality/compliance experience in an FDA and/or EU regulated industry
Thorough understanding of Quality Management Systems for API’s, drugs products, and medical devices, including risk management. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines
Ability to travel within the region
Must possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination product, Biologics, Vaccines, or API's or Non Sterile or Sterile Drug Product manufacture
Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of
External engagement in regulatory or industry forums. Current with regulatory expectations and requirements
Demonstrated ability to establish and maintain collaborative relationships with key stakeholders
Experience with direct participation on interdisciplinary Due Diligence teams – with Sr. Mgt, inclusive of initial risk/ compliance assessment based on documentation
Knowledge and expertise in application of Quality Risk Management pertaining to auditing, above-site function/ processes, or technical areas
Knowledge of QBD development & submission requirements

Senior Spclst, Quality Systems & Compliance Resume Examples & Samples

Minimum of 5 years of manufacturing, technology, and/or quality experience within an FDA, and/or EU API, Drug Product, Medical Device or equivalent environment
Experience performing audits of external and internal manufacturers and testing laboratories. Must have a working knowledge of processes to support the manufacturing of APIs and Drug Products
Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines
Ability to work independently with limited supervision in a virtual-management environment
Excellent/accomplished communication, negotiation, and facilitation skills
Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives
Demonstrated ability for process improvement and to create/implement simple, compliant systems in a diversity of areas
Lean six-sigma belt / demonstrated process improvement experience
Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact

Head of Quality Systems & Improvement Resume Examples & Samples

Develop and agree strategy, resource and budget for the quality improvement team with the Global Quality and Reliability Director
Use benchmarking to identify quality improvement opportunities across Dyson
Define, agree and drive projects to realise quality improvements
Identify needs for quality training (internal and external to quality) and drive development and delivery of such training
Raise profile of quality within Dyson and its supply chain
Assess, manage and improve quality systems across all Dyson functions
Recruit, lead and manage a team to deliver the strategy
Build and direct a technically strong and influential team that supports others (internal and external to quality) in improving quality processes
Communicate quality leadership material at exec level
Degree in Engineering or similar
Extensive and demonstrable experience in an engineering environment, including design and manufacturing quality of a range of business environments, including ones subject to strict regulation
Working with and influencing different parts of an organisation
Effectively managing diverse technical improvement teams
Extensive experience of operations, quality, engineering or project management
Capable of effectively communicating with and gaining respect with technical and non-technical stakeholders

100

Quality Systems / Quality Specialist Resume Examples & Samples

Assisting the implementation of the Catalent Data integrity programme and subsequent management
Incorporating additional Trackwise workflows into the Bathgate Quality Management System and to provide additional Trackwise admin support
Perform independent quality review and approval of computer systems, equipment and facility validation documentation
Assist in the management of internal audit programme including executions of audit and participation in the annual quality audit
Support the
Support site Quality oversight including deviation and complaint management activities
Assist in Metrics collation and Management Review activities to ensure the site has appropriate oversight and is inspection ready
Record, monitor, participate within the investigation of, and sign off of, Deviations, Complaints, Corrections raised
BSC level in a relevant scientific topic or appropriate experience in a pharmaceutical environment
Experience working in a GMP environment is essential for this role
Demonstrable experience and sound knowledge of GMP regulations
Competence in both written and verbal communication
Good organizational skills,
Ability to interact with personnel at all levels from a variety of disciplines
Strong follow-up skills and attention to detail
Ability to work independently and to prioritise workload
Competitive Annual Salary
5 days holiday (inc 8 public holidays)
Pension
Life cover
Bupa Healthcare
Free onsite parking
Free drinks vending

101

Specialist, Quality Systems & Compliance Resume Examples & Samples

Performs Quality batch record review and approval
Performs Quality review and approval of master batch record updates
Performs Quality review and approval of new and updated SOPs and Controlled Job Aids
Performs GMP walk through inspections of assigned departments within the IPT to ensure compliance with cGMPs and regulatory requirements Assistance with external audits may also be required
Assists with training of incoming personnel and ensures compliance with departmental procedures
Assists in validation activities including protocol development
Assists in execution of aseptic process media simulation activities
Collaborates with Quality and IPT members in the identification and implementation of continuous improvement initiatives and action plans
Assists in the management and execution of critical quality systems such as change control, document management, Deviation management, etc
At least two years of relevant post-degree work experience in a laboratory, manufacturing, or Quality position
Evidence of leadership skills coupled with good oral and written communication skills
Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is preferred

102

Senior Specialist, Quality Systems Resume Examples & Samples

Evaluate the performance of key Quality Systems and Quality Assurance programs across sites as per the drivers of KPIs as identified by the Animal Health Line of Business (LOB) / MMD, including but not limited to
Market Actions
Deviation Reduction
Inspection Performance
Significant Investigations, including specifically those related to marketed product stability OOS results
Health Authority notifications and communications
CAPA and Commitment management (9-chart metrics)
Act as the primary liaison for the AH Quality Operations LOB Leader in assisting sites in complex compliance issues such as significant investigations
Partner with the Site AH Quality Director and the Director, AH Quality Systems Compliance, to support sites, as needed, during regulatory inspection and Division audits. This includes driving cross-site proactive approaches (mock inspection prep work and Quality and Compliance Excellence activities). Assist in conduct of inspections, as needed, and assure regulatory responses are of high quality and represent both site perspective as well as Division perspective
Co-ordinate a timely and effective internal escalation / external reporting processes for quality defects
Support an effective Fact Finding process to ensure that investigations into quality defects that have the potential to result in market action or in Health Authority notification are completed in a timely manner, with coherent root cause investigation, associated effective CAPA identification, clear recommendation on HA notification / convening of the Recall Committee, and timely issuance of the Fact Finding summary memo
Support AH Quality Operations LOB leader and Site Quality Heads to ensure high quality and timely Health Authority notifications and communications
Support AH Quality Operations LOB leader and Site Quality Heads on any recall activities by guiding sites in the preparation and follow-up of associated key activities
At least eight (8) years of work experience in a pharmaceutical, biologics and/or vaccine manufacturing environment or a strongly related, similarly regulated field
Strong understanding of cGMPs, FDA, EU, USDA and EPA regulatory standards
Strong knowledge, experience, and/or certification in Six Sigma, and/or MPS/Kata
Strong leadership skills and ability to work within a matrix organization to align on expectations and resolutions

103

Senior Quality Systems Associate Resume Examples & Samples

Develop quality systems policies and procedures, and perform revisions and periodic reviews
Evaluate and ensure completion and closure of change control records
Provide QA input to functional groups to evaluate and ensure proper closure of deviations, investigations, complaints and CAPAs
Execute on supplier qualification activities such as Supplier Corrective Action Requests, supporting supplier audits and writing audit reports
Assist with internal audits
Support regulatory and third party inspections
Follow up on actions related to audit observations
Interact with lab operations personnel to ensure compliance to company quality systems policies and procedures

104

Quality Systems Coordinator Resume Examples & Samples

Travel to other BioReference owned laboratories (40% travel)
Insure compliance with all regulatory agency standards for inspection readiness
Interact with staff outside of the QS Department
Review SOPs prior to lab director's review and signature
Review proficiency survey results and conduct corrective action investigations
Review quality control program for trends, biases, critical failures; interpret LV
1-3 years clinical laboratory or quality assurance/compliance experience preferred
Excellent verbal, written, and interpersonal communication skills
Strong analytical skills and problem solving abilities
Strong organizational and multitasking skills
Proficient use of Microsoft Word, Outlook, Excel, and PowerPoint
Enjoys working independently as well as with a team
Positive attitude, integrity, and excellent judgement

105

Quality Systems Support Intern Resume Examples & Samples

Maintain and provide daily reports as needed to support the department structure and information to our daily business
Monitor to ensure workflow and tasks are working correctly and communication flow is achieved
Train end users and team members on basic functionality
Work with management to create IT projects specific to their organizational goals
Review data to remove irrelevant information
Identify new opportunities for improvement
Provide concise data reports and clear data visualizations for management
Identify code problems and data-related issues and repair as needed
Utilize daily reports to determine trends and probability analysis
Other task as assigned by management

106

Senior Specialist Quality Systems Resume Examples & Samples

Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products
Assist project teams in planning, preparation, review and approval of quality documentation
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred
5+ years’ experience in quality assurance, quality oversight or relevant experience
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations
Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products
Experience working in both team setting and independently. Works well with manager guidance while able to manage own time
Strong oral (with all levels of management) and written communication skills needed
Runs and manages small to medium sized quality related projects

107

VP, Quality & Systems Improvement Resume Examples & Samples

Leads affiliate team and strategic planning focused on increasing the number of cardiovascular and stroke patients discharged annually from Get With The Guidelines-participating hospitals with additional focus on increasing the number of patient discharges representing underserved populations. Other goals include advancing adoption of AHA inpatient quality programs through expanded market penetration as demonstrated by increased contracts for GWTG Resuscitation; increasing the number of Quality Achievement Awards achieved by participating hospitals; launch of AHA programs dedicated to reducing cardiovascular disease and stroke by increasing the number of qualified provider organizations registered and implementing AHA programs; and increasing NSTEMI discharge population
Assumes full responsibility for developing and implementing regional strategic direction for the 11-state affiliate QSI team of Quality Systems Improvement/Mission: Lifeline staff and administrative team members
Develops transformational relationships to help advance the AHA mission through involvement in cultivation, securing, and stewarding relationships towards extraordinary results, including acquiring large health systems to be engaged in AHA programs focused on improving the cardiovascular health in communities
Provides leadership over a diverse and dynamic affiliate team to ensure the AHA carries out its mission while driving positive employee engagement. Includes setting integrated goals, developing staff performance standards, and holding staff accountable for meeting individual goals, which contribute to the overall team goals, department goals and AHA goals. Coaches and counsels staff on business methodologies/practices and organizational protocols ensuring the highest level of ethics are adhered. Interviews, selects and trains new direct reports. Evaluates performance of direct reports based on performance standards and team goals and priorities while providing direction and gaining commitment
Annually reviews and adjust affiliate Quality and Systems Improvement strategic plan while developing stakeholder and volunteer relationships to assist with the accomplishment of those plans
Regularly communicates on opportunities, issues, competitive initiatives, market trends and concerns. Provides consistent, timely and effective information, direction, standards, planning, and problem resolution
Management of affiliate Quality and Systems Improvement budgeted projects, corporate and grant-funded programs, and implementation of programs as needed to support Quality and Systems Improvement
Broad knowledge of hospital processes, care pathways, and hospital political culture
Cardiac and/or stroke care knowledge/experience
Demonstrated successful staff management, including the ability to train, guide and motivate staff to achieve objectives
Ability to effectively plan and manage workflow, work on multiple projects simultaneously, and manage project details with limited supervision
Demonstrated strategic thinking skills in assessing the local market environment and available resources to successfully implement new and existing programs
Ability to communicate, build relationships, gain trust, and effectively work with, train and inspire change across diverse audience of volunteers. Also, ability to effectively utilize, measure, and increase volunteer engagement at all levels
Strong written and verbal communication, including negotiation skills. Ability to effectively communicate AHA policies, guidelines, and strategic direction to volunteers and staff
Demonstrated knowledge of fundraising, grants, and maintaining relationships at corporate, government, and community levels. Consultative sales experience a plus
Ability to conceptualize, reason through problems, make effective decisions, and develop alternative solution and provide excellent customer service while ensuring compliance with the American Heart Association’s policies and procedures
High competency in computer technology
Ability to travel up to 50% of time throughout the affiliate including overnight travel, occasional trips to AHA National Center in Dallas, TX and attendance at occasional meetings and events taking place on evenings/weekends
Minimum of three years of management experience

108

Senior Specialist, Global Quality Systems Resume Examples & Samples

Lead cross-functional process teams in a matrixed environment to develop and implement Quality processes by inventorying existing systems, assessing gaps and opportunities for improvement, collecting stakeholder and customer feedback and implementing robust business process management (BPM) including documentation and change control
Drive business improvement and adherence to quality standards (ISO, TS & AS) by functioning as the point for resolution of issues and continuous improvement
Work with both internal and third-party suppliers of software solutions to ensure standardization across FABs while meeting the diverse needs of a global organization
Support Site Quality Teams in Quality Management System implementation and execution
Work, as required, with other Corporate Quality Organizations to ensure standardization and incorporation of processes into Quality Management System
Lead and project manage key transformation activities and assist in organizational alignment
Set goals, track & drive key performance indicators for entire upstream QA group
Associates Degree in Engineering or Science or a relevant technical discipline and 7 years related experience OR
Bachelor’s Degree in Engineering or Science or a relevant technical discipline and 5 years related experience
Experience in manufacturing environment
Strong influence management skills
Solid knowledge of ISO-9001, ISO/TS16949 &AS-9100 quality systems, SPC & TQM concepts
Quality audit experience or certification
Strong background in Quality Management Systems implementation
Demonstrated ability to communicate well with all levels of the organization particularly in a global environment and experience in working with external constituencies
Strong organizational skills; demonstrated ability to manage multiple tasks simultaneously and able to react to shifting priorities to meet business needs
Demonstrated ability to meet deadlines and commitments

109

Lead Business Analyst, Quality Systems Resume Examples & Samples

Provides technical assistance in identifying, evaluating, and developing systems and procedures that are cost effective and meet business requirements
Assist with / participate on teams that support recurring events: close, annual year end, etc
Strong experience with the following systems: TrackWise, OpenText Livelink / Content Server, and / or other Enterprise Quality Management and Document Management systems
Strong experience in project management
Working understanding of GxP guidelines including 21 CFR Part 11
Experience in coordination of contract staff
Must have a desire to learn new technologies both by instruction and self-teaching
Super-user understanding of MS Office applications (Word, Excel, Visio, Access, Project, Power Point)

110

Quality Systems Resume Examples & Samples

Assist in maintenance of QSRC input on continuous improvement of customer facing systems
Support the requirement of QSRC processes surrounding timely analysis and completion of field reports, service requests and customer complaints
Support the monitoring and reporting of metrics related to analysis and completion of field reports, service requests and customer complaints
Work with Field Action Board coordinator and QSRC to ensure field activities, including Field Corrections, Field Actions and Field Notifications are handled in a compliant, complete and timely manner
Support QSRC with timely and complaint review of document and labeling changes
Support Quality Systems in implementing continuous improvement throughout the business systems
Continuously review requirements and practices in customer-facing responsibilities to ensure compliance to business, customer and regulatory needs
BS in a Life Science Major or a related discipline
A minimum of 4-6 years direct related experience working within medical device/medical diagnostic industries
Understanding of quality compliance requirements in relationship to product performance and customer expectations
Effective technical, analytical and organizational skills
Effective written communication, interpersonal, negotiations and problem solving skills
Effective communicator of technical and non-technical information
Strong PowerPoint, Excel and Word knowledge
Ability to work in an office environment

111

Metrology Gage Calibration Technician Quality Systems Technician Resume Examples & Samples

Perform, assist, evaluate and report measurement calibrations & Process Capability Studies
Calibrate, maintain and approve measuring devices
Perform point to point measurements on Optical Comparator and Video Measuring machine
Write user instructions and assist other employees on the use of gages
Maintain and update records
Assist with gage R & R (Repeatability and Reproducibility)
Assist with follow-up on equipment orders or services
Associate will be trained in and perform multiple work assignments
Assist in training other SPC and Gage Control Specialists
Must be proficient in the use of micrometers, calipers, read blue prints and drawings and use of gages and Optical Comparator
Must be able to interpret basic product and tool drawings
Subject to skill testing on the above
Subject to pre-employment physical and drug screen and background screening

112

Analyst, Quality Systems Resume Examples & Samples

Provide support for quality system simplification and standardization activities, including project management tasks such as facilitating meetings, contributing to process mapping and related improvement exercises, creating and revising quality system documents, following up on assigned actions, creating and sharing communication updates, and others as applicable
Support the corporate quality system Training program by helping various stakeholders establish and maintain training curricula, helping drive improvements to the learning management system and associated procedures, and identifying and executing upon opportunities to improve delivery methods and effectiveness of training courses and modules
Execute activities in support of the corporate CAPA program. This includes but is not limited to facilitating activities associated with CAPA Board meetings, and compiling, analyzing and distributing reports regarding CAPA process performance
Other incidental duties including collecting and compiling quality system metrics, supporting external audits, management review meetings, change management and post market surveillance activities
Bachelor's Degree with at least 3 years of related experience in a quality and/or manufacturing environment in the medical device or pharmaceutical industry
Proficient in MS Office Suite
Experience managing project activities, including use of software and communication tools
Strong written communication skills including owning and contributing to various documents including investigations, procedures, project status reports and technical analyses
Strong verbal communication skills including interacting professionally with all organizational levels, developing and maintaining effective relationships
Solid problem-solving and critical thinking skills
Strict attention to detail with demonstrated understanding of broader context, priority and significance
Demonstrated understanding and application of medical devices regulations and standards (e.g., FDA (21 CFR Part 820), ISO13485, and ISO 14971)
Understanding of Edwards policies, procedures, and guidelines relevant to quality systems
Demonstrates good judgment by proactively escalating issues as appropriate
Ability to manage competing and changing priorities in a fast-paced environment

113

Senior Engineer, Quality Systems Resume Examples & Samples

Knowledge of disposable nonwovens converting processes preferred
Previous working experience in a GMP/Regulated environment preferred
Demonstrated knowledge of statistics
Previous Six Sigma and Lean Manufacturing experience preferred
Working knowledge of 21 CFR820 and / or ISO 13485
Black Belt Certification

114

Quality Systems Lead Resume Examples & Samples

Pharm. D or M.Sc. in Chemistry or Microbiology
7-10 years’ experience in manufacturing/ manufacturing science and technology/technical development/Quality
3-5 year of Managerial experience
Thorough understanding of manufacturing processes and related process equipment
Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
5 years’ experience in executing process validation, having led and managed validation projects
Expert in reviewing and writing technical reports
Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)
Fundamental understanding of standard pharmaceutical analytical testing
One to three year experience of Quality Control
Five year experience in QA operation
Two year experience in QA documentation, compliance and validation

115

Project Quality Systems Lead Resume Examples & Samples

Supporting Project Manager to achieve business objectives & performance in line with Project goals and KPI’s
Liaising with site Quality leads on gathering data relating to the management of the quality processes, including Non-Conformance, CAPA, Complaints, Document Management, Training Management, Audit Management and Supplier Quality Management
Raising any concerns and / or project risks to the Project Manager
Providing updates to the site Quality Leads on project progress
Issuing data requests to the site Quality Leads & collating the data returned from the process experts
Coordinating training activities across all sites and delivering training as required
Preparing and updating Quality System procedures and associated documentation while maintaining compliance with quality standards and individual site requirements
Performing an active role in project planning and risk management from a quality perspective
Having a good working knowledge of ISO/FDA/MDD and other Medical Device Manufacturing related regulatory requirements
Maintaining relevant documentation to comply with quality standards and project requirements
Development and executing Validation documentation
Developing strong links with site Quality Leads and other project stakeholders

116

Specialist, Quality Systems, NA Resume Examples & Samples

Coordinate customer specification review process
Screen incoming specification requests to ensure they are applicable to West products and suitable for review
Work globally with Sales, Account Services, Technical Support, manufacturing facilities and customers as required to review and administer customer specifications for Domestic and International customers
Maintain the SAP system, Excel spreadsheet and Controlled Drawing Database
Manage and control hard copy files of master specifications and customer specific specifications
Work within the group and other departments to meet target customer satisfaction goals of reduced specification turnaround time
Perform and coordinate the certification process
Create/Maintain certification profiles as needed
Assign new/revised item numbers to appropriate certification profile
Support and trouble shoot certification issues for plants and customers
Perform and coordinate the internal specification process
Create internal product specifications for launch of new product lines
Maintain existing internal product specifications
Perform and coordinate the customer drawing control
Administrate controlled drawing database
Coordinate customer communication/notifications on change to drawings when necessary
Perform other responsibilities as assigned to support Quality Assurance initiatives
Assure compliance to procedures, ISO 9000 standard and adherence to Current Good Manufacturing Practices

117

Specialist, Quality Systems Resume Examples & Samples

Interface with internal and external customers to support projects and programs
Coordinate and lead change activities associated with the evaluation/change of materials or suppliers
Help establish systems for tracking progress and providing updates for key processes and projects (Supplier Scorecards, supplier performance, material change activities, etc.)
Manage documentation within Quality Systems, West Analytical Services, and other functional areas to ensure compliance with internal procedures and regulatory requirements
Serve as a system back-up for the document management system (MasterControl) supporting West’s global network, including document management, user account management and troubleshooting
Provide support for the development of procedures and work instructions across the global network, including technical editing and writing
Support business unit and corporate harmonization initiatives as they pertain to the quality management system
Use independent judgment, as necessary, in developing systems/processes for use within Quality Systems
As appropriate, use knowledge and experience to solve straightforward problems
Work with a moderate level of guidance/supervision
Education or Equivalent Experience: Bachelor's in scientific discipline preferred. Applicable work background and experience may be considered as a substitute
Experience: 3-5 years of experience
Experience in a regulated industry such as medical device or pharmaceuticals
Knowledge of cGMP, cGDP
Experience working directly with customers and suppliers
Familiarity with document management databases, particularly MasterControl
Experience with ERP systems, particularly SAP
Experience with statistical software, particularly Excel and Minitab

118

Quality Systems Supervisor Resume Examples & Samples

Provides daily supervision of QS staff and activities
Provides support in the development, implementation and maintenance of quality systems
May be responsible for one or more of the following

119

Quality Systems Co-op Resume Examples & Samples

Monitor quality specifications for finished product production at Neenah Converting
Monitor hold process and COPES process to assure investigations are completed by production in a timely manner
Work with operation employees to solve problems which occur and effect product quality
Attend meetings as required
Perform product and physical property testing as necessary to supply data to Production, Quality Specialists and Corporate Quality
Assist with quality complaints and follow-up when directed by Quality Specialist
Issue reports detailing quality issues, and physical product testing
Assist with conducting Quality Audits when necessary
Become familiar with sanitation standards. Assist with implementation of the standards
Assist with or direct special projects under the direction of the Quality Specialists
Assist Continuous Improvement Engineers with product or process improvement projects in support of Lean Manufacturing, Six Sigma, and Manufacturing Excellence processes
Enrolled in a Four (4) year college degree program in Quality Systems, Manufacturing Engineering, or related field
Mathematical aptitude and computer skills required
Ability to communicate well both orally and in writing
Proficiency in Microsoft Excel, and Outlook
Ability to travel up to 5% of time to domestic or international locations

120

Quality Systems Professional Resume Examples & Samples

Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management
Risk Managment - Applies basic Risk Management principles to work. Participates in the development or modification of Risk anagement files
Non-conformance Evaluation & CAPA Investigation - Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility
Technical/Business Knowledge - Job Skills: Working knowledge and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
Cognitive Skills - Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment

121

Specialist Quality Systems PLC Resume Examples & Samples

1 Supervises, prioritizes and directs the daily activities of the PLC Quality Associate (QSA). Ensures that required activities related to handling of unsuitable units are completed in the absence of the QCS
2 Primary responsibility for the QA release of plasma from the PLC. Verifies that all shipment contents meet SOP, regulator and customer specification requirements prior to release. Maintains a thorough working knowledge of customer requirements to identify and prevent potential shipment errors. Utilizes the LOGIC (CSL integrated inventory management and delivery system), SPI and ancillary systems as applicable per shipment and customer type
3 Ensures by oversight and periodic audit that the process of managing lookbacks and other unacceptable units is properly performed by the QSA according to current SOPs for each of the systems in use at the PLC
4 Primary responsibility for the verification of incoming shipments of source or recovered plasma to the PLC. Performs quality acceptance functions in the LOGIC or SPI systems as appropriate after ensuring that shipment meets all temperature, labeling and documentation requirements. Manages all information regarding any nonconformity noted within the appropriate system and maintain hard-copy documentation to provide customer-specified information to final consignee at time of shipment
5 Primary responsibility for the quality review of both incoming and outgoing shipments of intermediates (cryoprecipitate, paste). Ensures that customer supplied material is accurately picked and packed for shipment to the final consignee, and that appropriate documentation regarding any nonconformities is maintained and provided to the customer per specification
6 Maintains the PLC feedback system utilized to notify CSL and recovered plasma centers in the event of nonconformities noted during the plasma acceptance process. These nonconformities may include, but are not limited to, documentation errors, damage due to inappropriate packaging and paperwork discrepancies. Ensures affected plasma is quarantined, and works with the responsible parties to correct issues so that plasma can be accepted into inventory or marked for destruction as appropriate. Tracks and trends incoming exceptions and provides data to Manager for analysis and further action
7 Primary responsibility for the investigation and documentation of deviations noted because of routine compliance reviews, internal/external audits and/or customer complaints. Gather appropriate data to determine root cause. Collaborates with Operations and QA management in the development of appropriate corrective action and follows up to ensure timely closely of deviation reports. Coordinates exchange of information and follows-up activities with Corporate Customer Complaint Management per current SOPs
8 Responsible for oversight of temperature-monitoring systems & devices at the facility. Monitors the computer-control (facility temperature control system) on a daily basis to ensure system is functioning properly and those acceptable temperatures are being maintained throughout the system. Reviews temperature charts and logs on a weekly basis (at time of change) to ensure documentation is complete, accurate and within acceptable limits
9 Primary responsibility for the management of temperature deviations when noted at the PLC facility, during inbound shipment of plasma to the PLC, or outbound shipments when reported by CSL representatives in the EU. Collects all appropriate data regarding storage and transportation temperatures throughout the life of the product form the time of collection. Analyzes data to ensure all records are complete, and submits package for final disposition review by Regulatory Affairs
10 Oversees the Product Disposition process and documentation maintenance. Receives requests from CSL centers and other facilities for final product disposition verification for released to FDA and other auditors. Maintains appropriate documentation for all electronic and manual systems used at the PLC to ensure timely access to Product disposition information
11 Primary responsibility for conducting monthly process audits at the PLC. Monitors the performance of warehouse and QA staff against SOP and regulatory requirements following established checklists. Documents any nonconformity noted and works with Operations and QA management to develop appropriate corrective action plans to ensure continued compliance
12 Primary responsibility for PLC calibration requirements. Maintains a calibration calendar and schedules appropriate re-calibrations when due. Performs semi-annual calibration of temperature probes associated with the computer-control system
13 Assists in the development of SOPs and training materials for cGMP, Quality Systems, Safety & Operational procedures as required. Delivers quality systems training to warehouse associates. Maintains training records for facility employees, ensuring that all documentation is complete and accurate prior to employee being released to perform their duties without direct supervision. Oversees on-site record retention process
14 Collects data related to established PLC QA key performance indicators. Notifies manager if significant system failures or trends are noted
5-7 years’ experience in an FDA-regulated industry
Quality Assurance auditing and compliance experience and plasma industry experience preferred

122

CPO Compliance Quality Systems Resume Examples & Samples

The individual will comply with Good Manufacturing Practices, Health, Safety and Environmental policies and other federal regulations and company policies and procedures
Proficiency in computerized systems and general office work
MS Office 2010 and 2013 (intermediate skill)
Typing 25 - 20 wpm with accuracy
Understanding of Biopharma Terminology
Able to lift up to 25lbs
Experience with Healthcare and Pharmacology terminology

123

Associate, Quality Systems Resume Examples & Samples

Assures all changes associated with Wilson TechOps procedures are assessed and tracked
Assures adequate processes are in place to manage required changes
Supports the administration of the eSDMS/database specific to the Wilson TechOps procedures, monitoring the progress of the records
Assures all responsible individuals involved in the eSDMS process are trained on the process
Supports preparation of assigned metrics to assist the organization in addressing any significant trends
Provides assistance to Sandoz US personnel in relation to document management and archiving issues
Responsible for working with system user in a variety of departments to gain a comprehensive understanding of their business processes and system needs. Uses that knowledge to assist in the translation of the business needs to the applications/systems to create and implement projects which will meet those business needs. Interface with all user departments within the company as required
Provides on-going evaluation of various system functions to identify area for improvement. Communicates actively with users and management regarding changes, problems, enhancements and potential impact of changes
May deliver and develop training programs in support of six sigma activities, SOP changes/updates and new software
Supports system issue resolution and submits change requests to Global for resolution/evaluation
Provides support as needed to all Wilson TechOps Quality Systems which may include but are not limited to Change Control, Document Management, Training, Quality Events (including Protocols), Deviations, Actions, Supplier and Contractor Quality Management, APRs, Internal Audits
Maintain required GMP validation and change control documentation
Work is assigned and general instructions given for routine work; more detailed instruction is provided for new projects
Applies knowledge of company policies and standard practices to resolve problems. Analyzes issues and uses judgment to make decisions. Escalate nonstandard problem or issues
Accountable for track and trend Quality Systems statuses and report monthly metrics
May be required to assist teammates in performing tasks including but not limited to: Change Control Coordination; SOP Coordination; Site Metrics Reporting; QA approval of QC Documents; DEA Compliance and Authoring Annual Product Reviews
Exemplifies Sandoz Priority Values and Behaviors: Customer/Quality Focus, Fast/Action-Oriented/Initiative/Simplicity, Mutual respect/Candor/Trust/Integrity/Loyalty
Must be proficient with MS Office, MS Powerpoint, Excel and have the ability to easily adapt to new systems as required. Very good written and oral communication skills. Very good teamwork, people skills and ability to work in a collaborative manner with cross functional teams
Adherence to all health, safety & environmental requirements in support of departmental and site HSE goals. Work in a safe and efficient manner
Fluent in written and spoken
4 - 8 years of related experience or 10 plus years of Pharmaceutical experience strongly preferred (must include Quality/Compliance/Regulatory experience)
Experience in GMP Environment
Requires experience in Pharmaceutical manufacturing operations and quality systems operations with a broad understanding of requirements for systems
Preferred experience in both sterile and non-sterile products

124

Quality Systems Coordinator Resume Examples & Samples

Ensures that daily, weekly, monthly records and reports are accurately maintained
Assists with disposition of raw materials and finished product utilizing hold and release process in SAP
Maintains proficiency in SAP process flow and application. Must be able to quickly retrieve and understand data to support FDA, USDA, external, and internal audit requests
Perform tasks required during a real or simulated (mock recall) product recall. This includes but not limited to SAP functions, paperwork retrieval, communication with corporate, and the distribution centers
Ensures that the food processing equipment, floors, and facilities have been properly cleaned and sanitized in accordance with all applicable laws and regulations by outside agencies such as the FDA, USDA, and AIB pertaining a food manufacturing facility
Establishes a cross-functional partnership with other departments and functional areas to provide immediate solutions to safety, food safety, quality, cost, and environmental concerns
Provides Operations Manager, Team Leader, QA Team Leader(s), and Plant Manager with updates pertaining to any food safety or environmental concern that arises through the formal corrective action process
Understands and is accountable for full compliance with safety and other EOHS requirements
Understand and comply with Hill’s policies, safety standards, Good Manufacturing Practices (GMPs) and Food Safety. Identify and report Food Safety issues to management
Bachelor’s degree or higher in a science-related field
Ability to work in all types of weather
Ability to climb, crawl and kneel as needed to perform the functions of the job
Ability to work off shifts and weekends as needed
Two years of Quality Department work experience in a manufacturing environment
Ability to review and understand microbiological data
Computer skills including data base management, email, Microsoft word, MS Excel, & MS Power point
Lead by example the cGMP’s

125

Senior Specialist, Quality Systems Resume Examples & Samples

Responsible for implementating and maintaining the effectiveness of the quality system by delivering the "perfect label" to our customers through an effective and efficient lable management process
Monitor changes to legislation, regulations and statutes that may impact retention and/or require changes to the AbbVie Record Retention Schedule
Ensure completeness, accuracy and control of changes in labeling including proofreading of resulting label copy at various stages and for the development and maintenance of labeling related specification and documents associated with these specifications
Complete and route change requests for process document creation, maintenance, and implementation
Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits
Interact with internal and external partners for development of best practices in our quality systems and procedures. Meet with key stakeholders on a regular basis to review metrics and consult in the deveopment of action plans
Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system
Complete work according to established priorities to assure deliverables meet requirements. communicate and negotiate execptions to planned delivery dates
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred. Equivalent successful industry experience (min. 4 years) can be considered
Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Sciences, Manufacturing Operations, Supply Chain
Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products
Experience working in both team setting and independently. Works well with manager guidance while able to manage own time. Ability to make decisions and solve problems on key issues independently
Excellent interpersonal skills a plus

126

Quality Systems & Compliance Manager Resume Examples & Samples

Follow all Environmental, Health and Safety Rules and Regulations in the plant
Report any current or potential hazards to your manager immediately
The employee must wear the correct Personal Protective Equipment (P.P.E.) at all times for the work they are carrying out. Consult the appropriate SOP when required
This function has the responsibility for reviewing all SOP’s for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP
He/she should lead by example and follow all policies and procedures within the organization
The Quality Systems Manager must manage the internal plant-auditing schedule. This function is responsible for the preparation of external audits within the plant including leading plant teams
She/he must develop and carry out internal and external audits and monitor compliance levels throughout the plant
She/he will train all relevant employees in Quality Systems and Compliance matters including “QDMS” training
The Quality Systems Manager must review all plant procedures to ensure they are in line with policy requirements and plant expectations. This function must drive a simplistic approach to SOPs and ensure all procedures are understandable and clear
Provide Gap Analysis Documents for all changes to policies and procedures and where new policies become effective within the organization
This position may include management of other Q.A related projects as requested
This Job function will change where update procedures to cGMP, EHS, Technical / New Equipment, Quality Procedures & SOP’s are made
This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible where this need arises
To ensure Abbott Cootehill, Quality Assurance Policies and Procedures are in compliance with AQR, Divisional and market requirements. Ensure systems are in place and effective to monitor plant quality system and performance
Complaints and Investigations Co-ordinator
Quality Systems Specialist
Additionally the position will require a managerial role in the following areas
Leadership skills are a prerequisite for this position
Very good knowledge of the plant and all swabbing locations
Very good interpersonal skills
This position is responsible for ensuring that adequate procedures and controls are in place and communicated to all the employees so quality products are produced at all times. Failure to achieve this could result in product recall

127

Quality Systems Coordinator Resume Examples & Samples

Maintain system and integrity to meet quality expectations of the organization and to satisfy the requirements of the QMS and its customers
Identify, coordinate and monitor the implementation of all QMS related documentation needs including support of all team and project inputs linked to a documented business process
Coordinate consistent process documentation, monitor the approvals of QMS documents and maintain posting current documents to the various access tools such as Generac’s intranet, Powernet
Monitor and track QMS related compliance quality data and metrics
Support documentation needs development and act on direction to optimize the overall Generac Quality Management Documentation System
Maintain documentation consistency across the affected ISO certified and non-certified sites
Routinely monitor the documentation of the QMS Quality Metrics to assure communication is consistent and complete
Assign and maintain document identification numbers and archive developmental, current and obsolete QMS documents
Follow-up on internal and external quality audit corrective action items and status reporting as required
Associates Degree in Business, Technical Writing or related field OR 4 years related experience in the Operations function within a similar working environment
2 years related experience in a manufacturing environment
Ability to support and implement activities to meet internal customer expectations
Demonstrated ability to influence other individuals, teams and management
Quality Management System documentation background in ISO manufacturing environment
Sharepoint experience with document control

128

Quality Systems Specialists Resume Examples & Samples

ISO 9001/TS-16949 standards
Quality System Management
AIAG Core Tools: Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode Effects Analysis (FMEA), Measurement System Analysis (MSA) and Statistical Process Control (SPC)
Six Sigma DMAIC and Fault Tree Analysis
Suppliers, Inputs, Process, Outputs, Customers (SIPOC) Control Plans
Corrective Action Requests (CAR), Supplier Corrective Action Requests (SCAR), and Non-Conforming Material Reports (NCMR)
Positions require a Master’s degree in Mechanical, Industrial, Manufacturing, or Automobile Engineering or related field and 2 years of experience as a Supplier Quality Engineer, Quality Engineer, or related position
Alternatively, the employer will accept a Bachelor’s degree in Mechanical, Industrial, Manufacturing, or Automobile Engineering or related field and 5 years of experience as a Supplier Quality Engineer, Quality Engineer, or related position

129

Quality Systems Assistant Resume Examples & Samples

Insure incoming and production materials and components meet engineering and configuration requirements by analyzing supplier documentation for compliance to engineering and configuration requirements
Review and complete identified inspections according to manufacturing and inspection records ensuring compliance
Assist in First Article Inspections (FAI)
Prepare and present hardware/material packages to external customers for acceptance and sell-off
Provide analysis and data to support program investigations, fact finding SRB, SMRB
Solumina (Quality), Cost Point (Inventory) and Kronos (Timesheet) data base entries
Ability to read and understand drawing requirements
Assist in internal / external audits of procedures, inspections, and records
Tag material to the corresponding status

130

Global Quality Systems Intern Resume Examples & Samples

Extracts, analyzes and reports data and makes recommendations based on gaps, best practices, improvements or enhancements needed to ensure business processes maintain performance levels and evolve with the changes in regulatory and business changes
Working directly with peers/cross-functional teams; quality, regulatory affairs, manufacturing
Completes assigned project tasks and timelines and held accountable to them
Utilize programming and other data analysis or software skills to build on existing tools and/or make recommendations for other tools and software
Clarify quality, business data and analytical issues and helps to develop appropriate solutions
Gather and understand quality data metric requirements for reporting needs; support business functions and statistical processing
Experience using Microsoft Office and Excel, and/or Minitab computer software is an asset
Excellent verbal and written communication skills; good organization, project management, anaylytical and documentation skills
Goal oriented, interpersonal, self-motivated and team player able to operate well under direction

131

Lead Quality Systems Auditor Resume Examples & Samples

Follow up planning of each audit, including: notification of auditees, analysis, recommendation and submittal for approval of the Audit Plan, ensure that Audit Plan has been distributed to auditees, providing assistance to auditors during the steps of preparation
Interfacing between auditors and auditees. Acts as the facilitator of the audit
Ensure the completion of the audit. Ensure audit reports are completed and approved within the required time frame
Ensure that conclusions of the audit are understood by the auditees
Ensure that non-conformities and opportunities for improvement are correctly entered into TrackWise, and ensure that all appropriate persons are notified of the non-conformance(s)
Review responses and root cause analysis provided for the non-conformities and opportunities for improvement
Ensure Corrective/Preventive Actions (CAPA) are established and entered into TrackWise as applicable
Bachelors Degree with 3+ years industry experience or equivalent experience in related industry
Two years of auditing experience required
Auditing Certification is desired (ISO, CQA, etc)
Ability to effective communicate written and orally
Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, etc.)
Experience in the use of computers and applicable software (MS Windows, MS Office)
TrackWise Enterprise Quality Management Software experience a plus
Ability to multitask and manage multiple priorities

132

Associate, RA Quality Systems Resume Examples & Samples

Assists with and occasionally leads one or more projects in the following Quality Systems disciplines: Document Control, Corrective and Preventative Actions (CAPA), Training, Internal/External Audit
Document Control: Manages updates to division quality documents and leads SOP development and updates. Assists with Archive services and regulatory documentation
Corrective and Preventative Actions (CAPA): Creates process deviation and Nonconformance Reports. Drives for completion of corrective and preventative actions
Training: Manages the compliance training elements through the Learning Management Systems for Domestic and Overseas client base. Tracks metrics of on time completion. Provides Archiving
Training: Manages the compliance training elements through the Learning Management Systems for Domestic and Overseas client base. Tracks metrics of on time completion
Internal/External Audit: Manages the division level Internal Audit Program and works with audited areas to ensure timely completion of Corrective Actions. Serves as division liaison and inspection administrator for inspections by regulatory agencies
Executes accurate data entry into database and completes record keeping in a timely basis
Creates and distributes all necessary metrics reporting
Works with SMEs to implement quality business processes
Tracks metrics associated with data capture/entry effort
High school diploma or equivalent required; Bachelor’s degree preferred
3 years pharmaceutical industry or related experience required
Strong command of the English language, both oral and written required
1 year in quality related role (SOP Development, CAPA, Training, Quality Audits) required
Advanced word processing knowledge and experience with Microsoft Office Products required
Knowledge and hands on experience with Document Management Systems and data base systems required
Experience with creating databases a plus
Excellent organizational planning skills preferred

133

Quality Systems Tecnician Resume Examples & Samples

Audits processes, tests and inspects products and/or develops, compiles and evaluates statistical data to determine and maintain quality and reliability of products
Evaluates data and writes reports to validate or indicate deviations from existing standards
Recommends modifications of existing quality or production standards, programs or reports to achieve optimum quality within limits of equipment capability
Download quality information from quality system to be used for QA reports
Highly skilled with ability to move between shifts/ product lines
Demonstrates advanced technical skills which may be used to conduct on-the-job training and/or lead/guide other employees
Demonstrates knowledge of advanced technologies as well as functional techniques and improves processes
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals
Ability to speak effectively before groups of customers or employees of organization

134

Associate Specialist, Quality Systems Resume Examples & Samples

Functions as the MIDAS site steward
Assigns SOP effective dates in MIDAS to support business requirements
Leads and maintains standardized document control processes and procedures within the sites Standard Operating Procedures that are aligned with divisional and corporate standards, including Records Retention
Is responsible for the performance of the overall business process
Gathers, analyzes, and reports process performance metrics for the purpose of continuous improvement
Liaises with stakeholders within Quality and Operations; and assist with troubleshooting and problem resolution
Provides active support during audits and inspections (regulatory, internal, safety)
Performs other activities and special projects as directed
Generates domestic and international submission protocols for shipment and submission
Additional Functions
Attend team, department and corporate meetings as required
Attend seminars and/or classes as necessary to support business demands
Uses existing procedures to solve routine or standard problems
Applies limited judgment and discretion
Previous Experience in Document Management

135

Global Quality Systems Enterprise Lab Systems Resume Examples & Samples

Detail oriented with very good knowledge and understanding of Microsoft Office suite (Word, Excel, PowerPoint and Project)
Ability to work independently and drive assignments to completion
Very good interpersonal, verbal and written communication skills
Highly organized and very results oriented
General knowledge of laboratory operations, systems and equipment

136

Quality Systems Coordinator Resume Examples & Samples

Oversees and manages the day to day operations of the CGMBS training program including the class recordings, lecture/practical scheduling, exams, etc
Manages the document control system, including establishing permissions and ensuring completion of biennial reviews by all appropriate parties
Facilitates the training and competency assessment program for all applicable staff. Ensures that all training and competencies are completed as assigned
Review and trend deviation reports submitted by the clinical lab
Interfaces with regulatory agencies during inspections and audits
Minimum of 3 years experience in a clinical lab environment or equivalent
Ability to work independently and multi-task, with strong decision making skills
Detail oriented with effective verbal and written communication skills

137

Quality Systems Supervisor Resume Examples & Samples

Supervise Quality Engineering personnel to support appropriate tasks
Supervise Metrology Lab/CMM personnel to support appropriate tasks
Oversee AS9100 audits. To include scheduling/hosting 3rd party assessments & internal audits. Facilitating related problem solving, corrective actions, and process improvement activities
Oversee PRI Nadcap audits. To include scheduling/hosting 3rd party assessments & internal audits. Facilitating related problem solving, corrective actions, and process improvement activities
Oversee customer audits. To include scheduling/hosting 3rd party assessments & internal audits. Facilitating related problem solving, corrective actions, and process improvement activities
Oversee FAA oversight audits at 13 distributor hose shops. To include scheduling, performing onsite assessments, and corrective action follow-up
Create/Update/Deploy quality system processes and procedures to ensure compliance with Regulatory/Statutory, AS9100, Nadcap, EQS, and customer requirements
Develop and lead an internal audit program to ensure ongoing improvement and oversight of processes
Develop, set, and achieve goals associated with quality system improvements which align to Jackson Plant/Quality Department goals and objectives
Identify quality training needs of the plant and ensure those needs are addressed
Oversee internal and distributor periodic and sample testing per Eaton, PRI, Military, and other customer requirements
Oversee the pre-production approval process for all distributor hose shops including test sample tracking, approval of paperwork, and Cert of Authority Letter updates
Oversee the FAA DMIR approval process for all distributor hose shops
Support distributor hose shop Nadcap certification processes or other related qualification activities
Bachelor's Degree from an accredited university
3 years of experience in a manufacturing environment
This position requires use of information or access to hardware which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.”
Six Sigma or Blackbelt certification
Read and understand Blue Prints, Specifications, and Requirements
Quality System Expert (e.g. AS9100, ISO 9001, TS16949
Lead QMS Auditor experience and certification
Experience with NADCAP

138

Quality Systems Auditor Resume Examples & Samples

Manages the company-wide audits and assessments. This includes audit planning, scheduling, conducting audits and post audit activities including findings closure
With the knowledge in various quality systems standards like ISO 9001, TS 16949, Business Excellence Maturity models like EFQM, MBNQA etc. Will be required to integrate various audit methodologies, best practices to drive and conduct audits across design groups, manufacturing sites, field service locations and various support functions
Drives Assessor/Auditor training and qualification programs with focus on consistency and capability development for all assigned Auditors
Collates and reports companywide audit results, performance metrics and tracks on-time execution of finding closure
Interfaces with various groups within the organization to measure the effectiveness of the audit program, feedbacks on improving audit methodology and continuously tries to improve the process, methods and results of the audit program
Attempts to continuously benchmark the internal audit program with the best in class practices in the industry and tries to collaborate with industry peers
In depth and hands on knowledge of various quality systems certification standards like ISO 9001, ISO/TS 16949, VDA 6.1/6.3, AS 9100
Working knowledge of deploying all aspects of Quality Management Systems like process documentation, integration & optimization of business processes, training, audits and coordinating customer and external audits
Experience in implementing Business Excellence Maturity Models like EFQM, MBNQA etc. with qualification/experience of doing maturity assessments will be an added advantage
Planning, executing, measuring and reporting of audit management program across large and multi-site locations spread across various geographies will be required qualification
Working with various groups within the organization and at various hierarchy to drive improvements identified through audit programs required
Experience in liaising with vendors/consultants and certification agencies to partner on managing organization wide quality systems deployment and certification
Strong analytical, influencing and negotiation skills
Ability to provide internal relationship management in a global, matrix organization
Excellent managerial, communication, interpersonal and technical skills
Working in global culture and context a must for this role

139

Analyst, Quality Systems Resume Examples & Samples

Provide support for quality system activities, including project management tasks such as facilitating meetings, creating and revising quality system documents, following up on assigned actions, creating and sharing communication updates, and others as applicable
Help create and maintain training plans
Support the TMTT & AT quality system training program by helping establish and maintain training curricula, coordinate various training courses
Execute activities in support of the quality system implementation, including but not limited to compiling, analyzing and distributing reports of NCR, CAPA, Customer Complaints
Other incidental duties including collecting and compiling quality system metrics, supporting internal and external audits, management review meetings
May conduct internal audit if experienced and capable
Proficient in MS Office Suite, especially Word & Excel
Strong written communication skills for owning and contributing to various documents including investigations, procedures, project status reports and technical analyses
Strong verbal communication skills for interacting professionally with all organizational levels, developing and maintaining effective relationships
Strong analytical skills using Excel for data collection, analysis, trending and charting
Understanding of Edwards policies, procedures, and guidelines relevant to quality systems, and having auditor training and certification will be a big plus

140

Senior Principal Auditor Global Quality Systems Resume Examples & Samples

Our ideal candidate will need to have their Lead Auditor Certification
As our Auditor you will lead the expansion, inclusion and coordination of the Stryker Corporate Quality Audit program to ensure compliance to quality system requirements
We will need you to be our Subject matter authority and consulting in audit preparation and execution
You will maintain the master audit schedule and audit files. As well as assist in the summary reports and corrective action status
You will serve as lead auditor or audit participant for initial and follow-up audits
We will ask you to lead audits independently from planning through to execution, closure, reporting and post-audit follow-up
Coordinate audit teams as required
Ideally you will train and mentor fellow auditors both within the team but also across Stryker
Providing mentorship and course correction to fellow auditors when necessary
Plan and tailor the audit agenda and scope based on processes performed by the Division/Site and the site’s local priorities
Assisting in coordination of applicable compliance training
Interpreting applicable laws such as FDA, ISO, MDD and Stryker policies
Performing trend analysis of audit findings to identify areas for improvement
Presenting audit results and correlating data to key partners within Stryker
Participating with the Post Market Surveillance and Quality System Corporate audit teams, you will help provide beneficial information in support of the systems
Working with Division RAQA Heads, GQO Quality Management and International RAQA Management to assure alignment to the Global Quality System
We will want you to maintain fiscal responsibility and budget compliance, may be required to develop the team budget for monthly reporting
You will work independently under general supervision with considerable latitude for initiative and independent discernment
You will monitor external audits of Stryker sites. Provide corporate support to the site, communicate areas of interest to appropriate CPOs, and prepare daily summary reports

141

Quality Systems Program Leader Resume Examples & Samples

Leads the standardization, automation, and optimization of quality management systems
Leads development/ implementation of Business Intelligence solutions to expand reporting capabilities and bring visibility to issues, trends, improve processes, reduce costs and mitigate risks
Leads system upgrades, patch installations and associated Computer Systems Validation (CSV)
This position requires a four-year degree in the physical sciences or engineering. An advanced degree would be helpful
Incumbent should be an EtQ Reliance expert. In addition, the incumbent should have completed 2 sessions of EtQ Expert Training and at least 2 years of configuration experience in EtQ Reliance
Knowledge of system architecture, relational databases, SQL, Python, Javascipt, HTML, working with Application Servers
Experience with troubleshooting and performing technical investigations

142

Ww Quality Systems Leader Resume Examples & Samples

Bachelors or required
A minimum of 8 years of relevant experience is required
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE)
A minimum of 2 years supervisory experience is preferred
An understanding and application of GCP regulations and standards applied in clinical areas and medical devices/combination products is required
Clinical/medical background is preferred
A minimum of 2 years of Clinical Quality Control/Assurance experience
Medical Device and Pharma and/or CRO monitoring experience is preferred
Travel requirement is 20%, both domestic and internationally.3623170303

143

Quality Systems Summer Intern Resume Examples & Samples

Assist senior staff in performing statistical analytics and trend analysis of manufacturing data to demonstrate process consistency and capability
Use statistical tools to quantitatively detect problems within the drug manufacturing process and identify and document root causes
Identify opportunities to optimize processes that may pre-emptively increase quality reliability
Currently enrolled in a 4 year bachelor undergraduate program with a preferred focus in functional area of Biological Sciences, Chemical Engineering, Biochemistry or Bioengineering with completion of at least the Sophmore year
Graduate student preferred
At least a 3.0 GPA
Must have an advanced understanding of Biological Processes
Ability to work independently and multi-task
Strong computer skills with Microsoft Office with Advanced proficiency in Excel

144

Quality Systems Coordinator Resume Examples & Samples

Follows established company policies and procedures and applies acquired job skills to perform various quality systems tasks
Performs evaluation of internal controls, communications, risk assessments, and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards
Facilitates internal training on quality assurance requirements, processes, and procedures, as needed
Performs functions that require full knowledge of general aspects of the job
Works on assignments that are semi-routine in nature, but recognizes the need for occasional deviation from accepted practice
Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation
Escalates issues to supervisor for resolution, as deemed necessary
Minimum 1 – 2 years of related quality systems experience, preferably within a regulated industry
Efficient data entry using computer keyboard
Knowledge and experience in SAP preferred
Ability to work with limited supervision, multi-task, and possesses attention to detail
Experience in FDA regulated environment, pertinent to GMPs and ISO 13485 preferred
Basic knowledge of 21 CFR Part 11 compliance is a plus
Knowledge of MS tools including MS Office Suite, Adobe, and PTC Windchill preferred

145

Quality Systems Lead Resume Examples & Samples

Effective management of the QA resources through Eaton Leadership Model
Train and develop team members as well as providing oversight and coaching to other team members as part of the Development of Resources
Actively engage and recognize employees for their results and provide coaching for areas of opportunity
Empower employees – drive decision making down through organization
Work as a team with the support departments in order to define necessary actions to meet customer requirements
Support Eaton Initiatives and practices for the Development of People by using tools as the Succession Plans, OCA, ELM, CIF, FLL and EBS tools
Ensures that process needed for the Quality Management System are established, implemented, and maintained, based in requirements of AS9100, AS9102, EQS, and any other customer or regulatory requirements
Establishes objectives, policies, and procedures for Tijuana quality control activities
Ensure the promotion, awareness and deployment of internal, customer, and regulatory requirements throughout the Tijuana organization, including deployment of Eaton Business tools to improve business effectiveness (EQS, ELSS, WISPER, MESH, PROLaunch, etc)
Monitors overall Tijuana Quality Performance through managing the BSC and its various data sources and analysis, updates information in EPM, and makes or facilitates efforts to drive continual improvement
Ensure the implementation and sustain of the Quality Lead Indicators, including the Quality Best Practices
Works closely with local and plant ME and QE functions to ensure smooth transition of new product designs into the manufacturing gates (NPD and STP) including engagement in data analysis, Process Capability, FMEA, Control Plans and review/approval of QTP/QTR
Assists QM in obtaining, maintaining, and improving appropriate customer and regulatory approvals (i.e. QMS certification, NADCAP process certification, FAA, etc) including ensuring organizational readiness for customer, third party, and regulatory assessments
Coordinate and implement the PPAP Methodology based in the requirements of the Quality Organization
Coordinate the Document Control department and the implementation of the MCO process through all the organization
Ensure the Documentation Retention Program and the Scanning process is being followed by all departments in the organization
Oversight for all calibration system of the plant and make sure compliance with Customer’s requirements
Eaton Greenbelt Certification preferred
Knowledge of Aerospace Regulatory Environment, NADCAP processes and AS9100
Advanced Knowledge of the Eaton PROLaunch NPD and STP Process as well as DFSS
ASQ Certified Quality Engineer (or European Equiv.) preferably
Lead QMS Auditor
Working knowledge of Quality Management Systems standards and Aerospace Regulatory Requirements
Incumbent must be effective leader with exceptional personnel skills
Continual improvement mindset
Freedom to act in circumstances requiring QMS improvement
Minimum five (5) to ten (10) years in Quality Engineering environment
Strong capability to work within a multi-site, multi-discipline environment

146

Quality Systems Supervisor Resume Examples & Samples

Experience with Global Food Standard Initiative (such as BRC, ISO, SQF)
Practical knowledge and application of food safety principles such as HACCP, GMPs, etc
Implementing quality systems and effective auditing procedures

147

Quality Systems Auditor Resume Examples & Samples

Issuing related corrective actions and following up on effectiveness
Providing audit reports and trending of related information
This role requires travel up to 25% of the time
Knowledge of statistical processes and trending preferred
Certified Auditor preferred
Working knowledge of international standard ISO 13485:2016 for medical devices preferred
Working knowledge of 21 CFR Part 820, F.D.A. Quality System Regulation
Familiarity with medical device regulations MDR/MDD for European Union, Japanese MHLW, and Canadian CMDR preferred
Familiarity with 21 CFR Part 11, FDA Electronic Records / Electronic Signatures preferred

148

Associate, Quality Systems Resume Examples & Samples

Initiate workflows upon receipt of revision requests for all controlled document types (SOPs, forms, Quality Standards). Issuance of revised documents including archival of superseded documents. Initiate Biennial review workflows for controlled document types (SOPs, forms, quality standards). Write, review and update SOPS for forms related to document control procedures
Update training database and upload quizzes into the LOS training system for new/updated procedures
Assist as necessary to maintain filing system for but not limited to daily systems release reports, temperature charts, cleaning logs, equipment log books. Assist with annual archiving
Customer service functions assist with IDEA for CON issues, address issues with quizzes in the training system as needed
Assist with preparing aseptic fill records and associated sampling documents/labels, packaging records, solution records, and other production records per the production schedule(s). Provide second check of records prior to issuance to production as required

149

Lead Business Analyst, IT Quality Systems Resume Examples & Samples

Critically evaluates information gathered from multiple sources and reconciles conflicts
Dissects high-level information into details and is able to communicate details in a manner understood by relevant audiences
Collaborate within IT to understand enterprise platform roadmaps and maximize usage of our existing technologies
Acts as a liaison between client area and technical organization by planning, conducting, and directing the analysis of highly complex business problems to be solved with automated systems
Provide application technical support. Investigate and resolve issues. Liaise with software vendors as required
Experience within the pharmaceutical/biotech sector
Supporting business process mapping and system implementations for Technical Operations and Development Sciences functions
Some form of Programming highly desirable, but not required
Experience in other enterprise systems such as CMMS and HP Quality Center are desirable
Excellent verbal and written communication including strong presentation and group speaking skills
Must have good interpersonal skills

150

Associate Director of Quality Systems Resume Examples & Samples

Facilitate regular management review of quality performance metrics, designed to drive management behavior towards stable and compliant operations
Collaborate with colleagues to foster appropriate use of the systems to ensure global quality policies alignment and lead the evolution of QS to cost effectively meet user and business needs and comply with regulatory expectations
Develop and lead internal self-inspection audit and supplier management programs ensuring that all processes, materials and equipment are optimally serving business needs
Minimum 5 years management experience required, Quality Management concentration preferred
3-5 years successful experience in systems or process development required
Excellent troubleshooting skills combined with calm demeanor that is successful in working with external organizations in resolving significant Quality issues required
Demonstrated ability to successfully negotiate resolution of complex supplier performance issues
Demonstrated ability to develop direct reports to high levels of achievement and drive to contribute to business success
Proven ability to engage others, concisely communicate complex situations and plans under stressful circumstances in a manner that facilitates successful and timely resolution
Understand regulatory standards, various local, state and federal laws that apply to the business and where to find information on standards and interpretations
Excellent critical reasoning, decision-making, and problem solving skills to analyze situations, determine risks, find solutions to prevent future issues and resolve recurring defects
Strong organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
Strong leadership, written and verbal communication, interpersonal and presentation skills to drive results. May be required to lead teams without the benefit of a direct reporting relationship
Establish solid working relationships to interface with and support senior management, third parties and other positions and circumstances within the organization
Excellent customer service orientation with flexibility and adaptability to respond quickly to changes as required by the business operations
Maintain a professional demeanor and handle confidential information with discretion
Computer literate with proficiency in office applications and use of electronic quality and operational systems

151

Head, Quality Systems & Training Resume Examples & Samples

Lead & direct group of diverse resources (multiple areas of expertise), including people management of Sanofi employees. These teams include NA CSU System Experts, SOP & Training Ambassadors, Training Specialist/Coordinator, Investigational Product Manger & Specialists, and Record Managers
Direct creation & implementation of process improvement, compliance, standard operating procedures, best practices, and lessons learned for the NA CSU organization responsibilities, including applicable KPIs
Direct the development and implementation of NA CSU training modules (professional, GCP and skill type) in conjunction with the regional and in-house study management & monitoring teams, both in GCPs and scientific aspects; responsible to develop, then update regularly, robust training plan and strategy, including endorsement from NA CSU LT. Implement improvements and track progress to enhance the NA CSU training program
Responsible for oversight of the IP management team for US CSU studies
Bachelors’ degree
Minimum of 10 years of experience in the pharmaceutical industry
Minimum of 3 years managerial experience in medium to large pharmaceutical environment
Demonstration of strong leadership skills, communication, influencing, team management, negotiation and coaching skills required to interact with impacting departments representing the NA CSU
Proven ability to mobilize a diverse team, including highly skilled at managing people
Strong experience with metrics reporting, including leadership of initiatives with tangible deliverables and measurements of success
Excellent organizational and time management skills, including ability to prioritize between competing activities
Prior management of department or operations group is highly desirable

152

Quality & Systems Support Resume Examples & Samples

Provides administrative support, primarily to the Director of Quality & Systems
Supports and administrates the documentation of the integrated management system and the product compliance. Issues process descriptions, supports and coordinates the planning and completion of internal and external audits incl. maintaining the master action plan. Participates in or performs internal audits
Participates in or leads projects in the field of Quality & Systems. Produces reports as necessary
Arranges meeting agendas, takes notes as necessary and generates meeting reports and distributes to participants
Collates monthly reports for Quality & Systems. Works with the Quality & Systems team to maintain the relevant metrics
Coordinates travel, accommodations and schedules for business trips, also for visitors as necessary
Education in office management or equivalent experience
Excellent PC skills – fully proficient in Microsoft Office Package
Proficiency in local language (German) as well as English in spoken and written form
Basic training in Integrated Managements Systems and Internal Auditor preferred
Three+ years of experience in office and/or systems/project management
Excellent communications skills (English and German)
Ability to communicate at all levels of the organization, customers and authorities both nationally and internationally
Team orientation
Knowledge in various standards for management systems (e.g. ISO 9001, ISO 14011, OHSAS 18001, ISO 50001), product safety and conformity standards and regulations (e.g. IEC, EN, UL/CSA and EC directives) and understanding of national laws would be helpful

153

Senior Diector, Global Quality Systems Resume Examples & Samples

Provides strategic vision and expertise for establishing and managing Patheon’s global Quality System. Manages the development and implementation of Quality System standards, polices, guidance and SOPs
Works collaboratively to ensure that the Quality system is effectively and globally implemented
Stays current on industry trends and new regulatory requirements, updates the Quality System to meet the ever changing regulatory landscape
Establishes global metrics to monitoring the implementation and effectiveness of the Quality Systems
Monitor major client audits on a global basis for compliance trends
Leads or participates in quality projects, initiatives and due diligence activities
Establishes department goals and objectives in line with Corporate and organization goals
Direct and manages all aspects of the people processes including hiring and performance management
Assesses technical responses to questions and issues raised by regulatory agencies and customers
Represents the company as SME during regulatory and customer audits for global Quality System issues
Establishes inspection readiness program to ensure a constant state of inspection readiness globally
Provides reports, analysis, and recommendations regarding Quality Systems, regulatory trends, internal and customer audits to Senior Management
Minimum of 15 years professional working experience in pharmaceutical Global Quality Systems, QC, QA or related compliance experience with a minimum of 10 years aggregate experience leading Quality System programs. Minimum of 5 years of experience in a senior leadership role with proven ability to lead and manage a team across multiple manufacturing locations internationally. Master’s level degree in directly relevant discipline
Outstanding business leader with the skills, experience and passion to motivate and lead the Quality organization and inspire their team, keeping pace with the rapid growth of Patheon. This individual will bring a demonstrated record of defining successful Quality strategies and implementing them in complex, distributed businesses, including experience integrating acquisitions
In-depth understanding and application of cGMP principles, standards, and best practices in the US and ROW
Sound decision making capabilities. Well organized and detail oriented. Excellent interpersonal skills
Uses established scientific/technical acumen, strong interpersonal skills and thorough knowledge of Quality capabilities to favorably influence discussions
Ability to travel frequently, including internationally (25-40%) dependent on business needs

154

Quality Systems Associate Resume Examples & Samples

Maintain the document management system as required including management of templates, allocation of document numbers and review of draft documents
Authoring, review and approval of Quality Systems related procedures
Supports the ExM team for preparing for area and regional Quality Council meetings in addition to provision of relevant information/metrics for presentation
Supports the Deviation Management process as per the ExM procedures, facilitating the Investigation Review Board
Support Quality Systems Specialists in management of BMS quality systems as required
Act as the primary point of contact for the storage of Quality Documents within the ExM Document Archive
Compiling and performing GMP training to all ExM personnel, when appropriate
Support the management of quality documents (SOPs, Quality agreements, templates, forms) and records and maintain associated trackers as required
Support the on boarding of new personnel
Quality systems Framework Champion, facilitate the timely review of Corporate Quality System Framework directives/SOPs and policies and co-ordinate responses back to HQ
Author, track and make obsolete QSF document exception requests as required
Facilitate the timely ExM review of regulatory inspection observations from other BMS sites for site compliance
Collate metrics on a monthly basis
Prepare trend and status reports as required
Prepare and update training documents, courses and assessments. Deliver training to all relevant site personnel
Preferably a degree in Chemistry or Engineering or Science related Degree
A working knowledge of Quality Systems, preferably FDA or EU GMP
A minimum of 2 years’ experience in an API or Drug product environment, 1 of which must be in a quality systems or related role

155

Senior Business Analyst, IT Quality Systems Resume Examples & Samples

Collaborate cross-functionally to drive process improvement and document business processes
Participate on change control boards and design review committees
Perform fit / gap assessments and providing solution options with impact assessments
Work with external application developers or system integrators to implement functional and reporting applications
5+ Years supporting business process mapping and system implementations for Technical Operations and Development Sciences functions
Experience with Crystal Report development is desirable but not required
Proven track record of being able to apply technologies to business functions to maximize process performance
Must be able to work as part of a team as well as individually
Must be able to work with limited direction and be a self-starter

156

Quality Systems Technician Resume Examples & Samples

Under close supervision, acquires job skills and learns company policies and procedures to complete routine tasks. Fulfill duties in accordance with requirements of the QSR regulations, the ISO-9001 standard, Corporate and on-site policies and procedures
Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations
Develop plans by conducting analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories
Works on assignments that are routine in nature; determines whether or not communications regarding company equipment are complaints and whether or not complaints might be reportable to the FDA
Analyzes equipment complaints to determine the probability that the reported problem is resolved and, if not, whether additional action to resolve the problem needs to be taken
Assures laboratory equipment and instrumentation is calibrated and properly maintained
Performs operation, including routine maintenance/cleaning for analytical instruments to ensure proper operation
Documents investigation steps and results
Communicates with company personnel to investigate complaints
Follows all policies, guidelines, and Standard Operating Procedures (SOPs) as required
May refer to senior staff for assistance with day-to-day problems that may arise

157

Quality Systems Auditor Lead Resume Examples & Samples

Prepare and perform system audits utilizing established procedures and policies both individually and in cooperation with other audit team members
Partner with organizational functions to identify, define and implement global system and process improvements to enhance business effectiveness
Active Member of the Document Change Review Board (DCRB) ensuring the effectiveness of Garmin’s quality management and compliance systems
Prepare and publish quality system procedures
Create and distribute operational performance reports as directed by management
Provide direct support to the representative for Management Review activities
Address any conditions believed to be undesirable including conditions effecting; personnel and property safety, employee discrimination, or any other disregard of company policies by other persons
Address any departmental interface or requests that cannot be performed as requested without significantly impacting the other assigned essential functions and other responsibilities
Must possess a minimum of 8 years work experience in quality system auditing performing a role substantially similar to the essential functions of this job description
Must possess a minimum of 8 years’ experience in developing, implementing and following formal procedures and work instructions, relevant to Garmin’s business needs
Must possess a minimum of 8 years work experience working with ISO9001 or similar standards
Demonstrates advanced proficiency and knowledge of current Microsoft Office software
Demonstrates advanced knowledge and use of audit tools and standards/procedures
Must possess strong and proficient computer skills including MS Office applications

158

Head of Quality Systems & Validation Rio de Janeiro Manufacturing Site Resume Examples & Samples

Lead Quality System & Quality Validation activities to drive Maintenance and Continuous Improvement of an efficient Quality System to ensure Quality and Regulatory Compliance across the site site
Establish strategic goals and objectives and maintain full strategic responsibility for the “Quality Systems & Quality Validation” organization
Implement, realize and monitor Quality System elements, including PQS, APQR, Quality Systems Management Review, Quality metrics, SMF, TCM, Quality Risk Management and Document Management System and Change Records
Oversight of implementation and realization of Quality Validation activities including Process Validation, Cleaning Validation, CSV, QC Equipment Qualification, and Tech Transfer

159

Quality Systems Consultant Resume Examples & Samples

Implement and design portions of quality performance indicators, tools and processes for data
Bachelor’s degree in insurance, healthcare, or related field; may hold two-year post-high school
Three to five years of experience in a training development role
Two to four years of experience managing moderate to large projects
Strong facilitation, content design, and consulting skills
Strong leadership, communication, change management, and relationship
Ability to quickly understand new, complex tools, technologies, and systems
Good working knowledge of project management, research, and problem-

160

Quality & Systems Improvement Director Resume Examples & Samples

Identifying, cultivating and maintaining key market stakeholder and volunteer relationships impacting program goals such as: hospital systems, EMS providers, hospital association, IDPH, health plans, etc
Likely serve as Account Manager for state of stakeholder relationships impacting program goals such as Departments of Health or Quality Improvement Organizations as assigned by Vice-President, QSI
Overall customer relationship management including use of Microsoft Dynamics (association customer database)
Coordinate and conduct GWTG account management activities for assigned hospitals in market including implementation and quality improvement consulting
Market and implement the program including the Patient Management Tool and/or other related QSI program registries and data solutions
Provide hospital training sessions for PMT data entry and PMT data reporting as needed
Consult with appropriate hospital teams with respect to compliance issues and strategies to facilitate progress – in concert with recommendations from the VP of QSI
Responsible for the accredited and non-accredited workshops/webinars in primary market
Execution of all necessary pre-work activities required to launch all future GWTG modules and/or relevant AHA programs in the IL market
Trouble-shooting and follow-up on specific customer issues and PMT clinical questions
Facilitating all elements of the Get With The Guidelines program, under the supervision of the Vice-President
Other duties as assigned by the Vice-President
Must have at least 2 years of experience in the healthcare industry. Experience may include working in clinical, non-clinical, quality improvement, pharmaceuticals. Experience must include one of the following: 1) acute care hospital experience working directly on clinical quality or process improvement projects, 2) working with national cardiac clinical quality improvement program that incorporates data capture within a process improvement framework

161

Quality Systems Coordinator Resume Examples & Samples

Health Care industry understanding, working in a regulated environment
1-2
Advanced level Word, Excel, and PowerPoint
Ability to work autonomously & manage priorities
Data Entry

162

Quality & Systems Improvement Data Entry Resume Examples & Samples

One year hospital, clinical, quality improvement or EMS experience
Ability to use Microsoft products, computer software, run reports and maintain accurate data
Experience with electronic medical records (EMR) and data abstraction a plus
Experience with data analysis a plus
Cardiac care knowledge/experience a plus
Satisfactory background and reference checks upon offer of employment

163

Mgr., Quality Systems Cert & Change Control Resume Examples & Samples

Bachelors in Pharmaceutical, Food Science, Chemical Engineering or Science related field required or other closely related discipline with extensive significant experience can be considered in lieu of a Bachelor’s degree
5-7 years of in the food, pharmaceutical and or nutraceutical industry
Ability to write clear and effective policy and procedures; excellent oral and written interpersonal communication skills; proven business and technical writing skills
Demonstrated knowledge of manufacturing systems and processes; experience in implementing and/or improving quality systems; ability to data mine Oracle PQM and other databases; Fluent in applications such as MS Excel, Word
Management experience, including strategic planning and project planning, project management, and problem-solving skills
Teamwork; proven ability to be able to professionally advise subject matter, while working collaboratively in a friendly manner
Ability to facilitate and train associates in Root Cause Analysis and CAPA investigations as well as other cGMP topics
Experienced lead auditor in HACCP and cGMP`s as per 21CFR part 110 and 111 or 210 and 211
Knowledge of regulatory requirements for supplements, including knowledge of CFR part 11, data integrity assurance and auditing of electronic data and systems
Familiar with requirements of ISO e.g. 22000 and 17025, HACCP etc
Ability to analyze and determine trends in complex data sets and determine an effective course of action to reach an agreed solution as well as objectively evaluate program requirements and prioritize actions to achieve them
Good planning skills, organizational skills, decision making skills and effectively prioritize; effective at analytical thinking/ problem solving
Innovation, continuous learning, continuous improvement; thorough knowledge of change management and project management

164

Quality Systems Auditor Resume Examples & Samples

A Bachelor's degree in the Sciences, Engineering or equivalent
A minimum 10+ years' experience in Quality Assurance, Food Safety Assurance, Quality/Food Safety Control, Quality Engineering, New Product Development, Manufacturing, R&D/Technical and/or related and equivalent experience. 5+ years' experience as an Auditor
ASQ Certified Quality Auditor (CQA) - preferred
80% travel required - Work Remotely (near major airport). Would prefer this person be based in the Northeast

165

Senior Specialist, Quality Systems Resume Examples & Samples

Manage, process and approve Investigations, CAPA extension requests and change management records
Support Audits (Health Authority, Internal, Divisional)
Share in the support of the PSQTS system responsibilities owned by the Quality System Team
Proactively identify, develop and implement areas for work process improvement and efficiency
Minimum 8 years experience in Pharmaceutical or related industry
Experience in one or more fucntional areas such as quality control, quality assurance, laboratory, manufacturing, production, regulatory, research, development, supply chain, design, engineering
Good Manufacturing Practice (GMP) or related drug regulation knowledge and expertise, including EU requirements
Computer skills; knowledge and competency in PowerPoint, Excel, and Word
Ability to independently manage multiple priorities and projects
Familiarity with R&D or clinical supply areas and processes
Knowledge and competency in Trackwise
Regulatory or QP inspections
Superior skills in collaboration, teamwork, conflict management

166

Quality Systems Project Manager Resume Examples & Samples

Providing project management leadership for global, cross-functional quality systems project deployment
Ensuring clear, timely and action oriented communications with key stakeholders
Driving a customer first mindset though active engagement and relationship building
Driving successful integration of the Aerospace and Automotive quality systems
Leading upgrades in our Training and Life Cycle Management Systems
Supervising our Quality Systems Personnel
Collaborating on systems within the broader 3M (other divisions and globally)
Minimum of three (3) years combined project management leadership and quality systems experience
Master’s degree or higher in science, engineering or business from an accredited institution
Proven project management skills
Demonstrated ability to effectively lead global, complex, multi-disciplinary teams
Effective organizational and creative problem solving skills
Excellent verbal, written and interpersonal communication skills
Familiarity with applicable electronic systems
Familiarity with AS9100, ISO and TS16949 or IATF
Demonstrated ability to execute on deployment of quality systems with high complexity
Experience working with the laboratory, manufacturing, and business functions

167

Director Global Quality Systems Resume Examples & Samples

A minimum of a Bachelor’s degree is required. Degree in technical or life science related discipline is preferred
A minimum 10 years of experience in the field of Quality Systems and Compliance within a highly regulated medical industry is required
Comprehensive knowledge of applicable US and international regulatory requirements for design, development, manufacture, and post market surveillance and field actions is required
Regulatory inspection experience is required
Proven track record of development and implementation of efficient and effective quality system processes is required
At least five (5) years previous management experience including experience managing virtual teams required
Change management and Project management experience including issue resolution and root-cause analysis, required
A minimum of 15% travel is required with higher peaks possible and depending on business needs

168

Assoc Quality Systems Spec Resume Examples & Samples

Bachelor’s degree in relevant field required (i.e. engineering, life sciences)
Experience in medical or pharmaceutical industry. Individual with a suitable college degree or other relevant experience may qualify
Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis and office equipment (copier, fax machine)
Strong typing skills and ability to write business documents with minimal supervision
Strong verbal and written communication skills and ability to work in a team oriented environment
Ability to understand the functionality / intended use of complex medical devices
Excellent knowledge of spoken and written English
Understanding Quality Management Systems and process approach to QMS
Ability to work with remote teams and communicate with a wide range of cultures
Experience in developing processes and documentation, including process diagramming
Knowledge of SAP or other ERP system is desirable
Familiarity with process improvement and change management frameworks
Familiarity with document control process will be an asset
Analytical skills & pragmatic approach

169

Prin Quality Systems Spec Resume Examples & Samples

7+ Years of Quality System experience
Knowledge in medical device, pharmaceutical and/or a comparable regulated environment
Product Lifecycle Management (PLM) subject matter expertise
Experience working with non-conformances, corrective and preventative action and training reports
Extensive experience reviewing technical documentation

170

Quality Systems Director Resume Examples & Samples

Develops and deploy Quality and Compliance strategies that are aligned with Medtronic business strategy across areas of responsibility, including; ensuring standardization of best practices development of Lean Quality system, early sharing of quality issues/trends, and identification of opportunities for improvement
Reviews, directs and manages manufacturing and pharma QA strategies, organization, and execution for results. Ensures that approaches are innovative, industry leading, and meeting the needs of customers and CRHF business strategies
Collaborate with Rice Creek, Monmouth Junction, and MMI operations teams as well as other internal and external partners to ensure the strategy is executed to achieve significant and measurable results
Develops and maintains appropriate communications within and between CRHF and other businesses to deliver on Medtronic’s overall quality and operations needs worldwide, collaborating as appropriate to ensure synergies with and between organizations to leverage a harmonized approach whenever possible
Proactively manages quality assurance and compliance activities in order to produce the highest quality products and prevent defects
Creates a culture of continuous learning across areas of responsibilities where root causes on quality issues are identified and organizational learning is institutionalized
Ensures effective processes are established within the organization to monitor quality and compliance execution. Implement proactive and preventive strategies for the resolution of quality and compliance opportunities
Assures the processes used in the manufacturing of products are properly developed, characterized, qualified, and validated to assure the highest possible quality and to ensure an uninterrupted supply of quality product to meet the needs of our customers
Assures that manufacturing quality and performance data are comprehensively measured, trended, reported, and acted on in a timely manner to ensure compliance and support continuous improvement. Ensures constant vigilance in line rejects, manufacturing related field returns of those products and changes to manufacturing process to assure the highest possible quality
Creates a world class Quality organization ensuring top talent is hired, developed, and retained
Lead the strategic planning efforts for area of responsibilities Annual Operation Plan (AOP)
Experience in medical or high reliability product industry highly preferred
Experience in multiple Quality related functions is preferred
Highly results oriented and focused on business priorities
Strong leadership and influencing skills to drive results in a highly matrixed organization
Business and Quality perspective
Strong change management and transformation skills
Excellent Communication/Presentation Skills
Excellent Interpersonal and Talent Management skills

171

Senior Quality Systems Compliance Engineer Resume Examples & Samples

Manage CAPA Workstream, CAPA investigations, CAPA & compliance audit trending of quality data streams
Develop & establish continuously improving plans for site CAPA system, quality assurance programs & quality policies
Plan, schedule & execute internal quality audits program for ventilation design sites
Lead a team of auditor(s) to perform audits / assessments by collecting and analyzing objective evidence regarding issues and risks. Report findings (verbally and written) to management
Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management, as appropriate
Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance
Develop and maintain compliance policies supporting the Respiratory and Monitoring quality system
Lead process improvement projects and conduct training with Quality to improve the GBUs overall quality system compliance
Assist with site regulatory compliance specific needs such as external audit preparation, assessment of quality plans, responses to internal and external audit observations
Maintain working knowledge of existing and proposed domestic and international medical device regulations and guidance documents and their impact on Medtronics operations
Prepare management reports depicting trends and useful data for management review purposes
Support management during external inspections and participate in the management of external inspections as required
5+ years of experience in Quality Assurance, including Quality systems, standards, metrics, and tools
2+ years of experience with Risk Management, ISO 14971, FTA, Design FMEA
Ability to effectively influence and negotiate with all levels of an organization and leading effective/successful change initiatives

172

Senior Quality Systems Supv Resume Examples & Samples

Bachelor’s degree in Pharmacy mandatory
Very well English – Spanish
5+ years of QA related experience including broad multi-functional business experience along with 2+ years of project and/or people management experience
Working knowledge of the following key competencies

173

Senior Quality Systems Leader Resume Examples & Samples

Main quality systems such as CAPA, internal audits, training and more
Quality KPI
Lead the Quality systems team

174

Quality Systems Technician Resume Examples & Samples

Same responsibilities as defined within the Qumas Administrator Position Description
Responsible for managing workflow submissions on document changes to the Qumas Electronic Document Management System for the Ireland facility
Responsible for managing the Periodic Review Process in line with governing procedures
Responsible for training new personnel on Qumas and workflow request process
Ensuring the Document Control process is in compliance with Regulatory and Quality Systems requirements
Records management program activities
Supports external inspections as required
Coordination of Quality System’s Document Control and Records Management activities and ensuring compliance with Regulatory and Quality System requirements
Supports Quality System’s processes and projects including but not limited to Change Control, CAPA, Management Review and Nonconformance
Prepares custom reports on results on Quality System processes and related activities
Recommends and implements revisions, corrections and changes to procedures and methods
Compiles data to identify trends and proposes corrective action
Provides support to other departments on Quality/GMP requirements as required

175

Quality Systems & Document Specialist Resume Examples & Samples

Maintains and manage MasterControl document system and other QS databases
Maintains required formatting of SOPs
Maintain and control inventory of archived documents and process requests for documents within software system
Create and analyze quality metric reporting for trending
Coordination of offsite document storage
Maintain applicable databases, spreadsheets, and electronic records as needed
Maintains security of Archive room entry and temperature monitoring
Assists in completes documentation associated with vendor surveys requests.Normally receives minimal instructions on routine work and detailed instructions on new assignments
Perform job specific tasks in compliance with applicable Regulations, International. Standards, and WuXi AppTec Policies and Standard Operating Procedures
Understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practice (GMP) and working within a regulated industry
May interact with clients and vendors
May be required to work overtime
Associate’s Degree or equivalent applicable work experience
GLP/GMP experience preferred

176

Co-op-quality Systems Engineering Resume Examples & Samples

Ability to work independently and learn in a fast paced environment
Teamwork and collaboration
Courses in program management are a plus

177

Quality Systems Technician Resume Examples & Samples

Minimum 0 – 1 years of related experience
Understands basic concepts and principles of dialysis
Mathematical aptitude required with a good background in algebraic skills and measurement skills
Basic computer skills with database, spreadsheet, and word-processing programs
Understands fundamental concepts of working in analytical chemistry or microbiology lab as an analyst
General knowledge of GMP regulations, Good Laboratory Practices, or comparable Quality or laboratory standards
Knowledge of commonly used analytical chemistry and/or microbiological laboratory methods

178

Quality Systems Compliance Specialist Resume Examples & Samples

Manage the AFSR Rochester site’s Quality Systems and procedures to ensure they comply to all required customer and industry requirements. These include, but are not limited to (AS9100, ISO9001, NADCAP, RR:SABRe, S1000, ASQR01)
Coordinate and oversee all customer and industry required audits, certifications, and surveys related to Quality Systems
Working with QMS database/QPulse, change & maintain all controlled documents in the system
Train Internal Auditors and prepare, perform, support, and manage audits to ensure the integrity and compliance of all systems and procedures
Manage the Internal Audit Schedule for each year, assuring compliance with latest standards
Perform external audits of suppliers to guarantee the supplier’s conformity to all AFSR quality requirements
Manage the Corrective Action Request (CAR) system and hold regular meetings to discuss them as well as oversee the timely completion of all Root Cause and Corrective Actions, interfacing with customers whenever needed
Communicate and interface with customers relating to: 3rd party audits, responses to corrective actions, web site access to customer portals, and concession submittals
Initiate investigations for the Root Cause and develop containment activity as the 1st step into the RCCA (Root Cause & Corrective Action)
Coordinate with the facility's lean manufacturing initiatives in efforts to ensure that any and all process related changes are incorporated efficiently and effectively into the Quality System for the site
Assist the Operations and Human Resources Departments with the development of programs for operator certifications
Auditor skills
Strong interpersonal skills; able to interact with all levels of the plant
Very strong MS Excel, Access database and presentation experience
Able to effectively interface with all levels of Arconic Staff
Ability to give presentations to groups
Able to lead by influence
Bachelor’s Degree from an accredited Institution
Minimum 4 years of Quality experience in the Aerospace industry
Employees must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available for this position
This position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee
Experience with Aerospace High-temperature materials
Familiarity with Six Sigma, AS and ISO standards, and Lean or Theory of Constraints experience preferred
Familiar with different computer applications used on PC computers such as statistical tools used for investigation, scheduling and/or ERP systems (i.e. Visual Manufacturing,), other MS-Office applications (Word, PowerPoint, Outlook, etc)
Knowledge of root cause and corrective action tools

179

Senior Mgr Quality Systems Resume Examples & Samples

Lead team to facilitate, and support Management Review, Internal Audits, Complaint Management, CAPA Management, Quality Metrics, Document Control, Training, Nonconformance Management, Field Actions, Software Validation, Post Market Surveillance, Maintaining Certifications and Registrations. Maintain current knowledge of applicable cGMP/QSR, ISO, and other related regulations
Manage and develop department budget in accordance with Annual Operating Plan
Lead and manage all regulatory inspections
Responsible for the development and administration of the Employee Training Program, including all GMP-related training. Responsible for the development and/or administer GMP training regularly to the facility, including orientation of all new regular and temporary personnel
Responsible for leading all process and procedural improvements for the Quality System
Team Leadership
Building Collaboration
Creating Alignment
3+ years’ experience supervising people or complex project management experience required
10+ years relevant industry experience required

180

Quality Systems Lead Resume Examples & Samples

Administration of SOP’s, WI’s and controlled documentation
Assist in QMS harmonisation activities within the European Quality structure
Maintenance of GMP systems in line with industry guidelines
Completion of internal and supplier audits in line with the site schedule
Handling internal complaints
Administration of the change control systems. This includes tracking, monitoring and
Reporting on change progress
Prepare validation documentation in line with customer and industry expectations
Previous experience within a similar Quality position
Previous experience of carrying out internal audits
Experience of using root cause analysis tools and techniques
Ability to multi-task and prioritise workloads
Experience of working to quality standards
Previous experience of ISO9001 and ISO14001
Ability to maintain a QMS

181

Business Unit Quality Systems & Continuous Improvement Specialist Resume Examples & Samples

Lead IATF16949 QMS transition for the site
Develop the Management Systems strategy and the business unit coordination with key milestones and deliverables to ensure flawless introduction of IATF16949 and maintenance of QM System certification
Manage all external registration requirements to ensure they are met. Single point of contact with external parties on all matters relating to registration and quality management system of the site
Lead and coordinate business unit continuous improvement program with all applicable sites
Create new idea to improve operation, recommend and implement continuous improvement activities and process to optimize business results
Lead introduction of new tools, systems and technologies to improve business process efficiency
Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and external certifying bodies
Lead site’s audit team, implement audit plan, coordinate internal auditors
Onsite training of staff in all aspects of the quality system and applicable procedures
Manufacturing or Engineering degree or equivalent experience; 5 plus years of experience in automotive
Six Sigma Black Belt Certification
Strong knowledge of the latest Automotive tools and techniques
Automotive Quality Management System Auditing experience
Detailed understanding of TS16949, ISO14001 / ISO 9001 / IATF16949
Membership of an industry related professional body would be preferred
Excellent attention to detail and process/system orientation

182

Director Global Quality Systems Resume Examples & Samples

Business ownership of Otsuka’s Global Quality Systems (e.g., learning, controlled documents, audits, and CAPA / deviation management) that serve as the solutions to meet Global Quality objectives
Manages stakeholder and GQ team engagement to ensure planning, implementation, and appropriate utilization of systems
Develops, communicates, and builds consensus for goals and programs that support team and company objectives
Leads the quality business teams for responsibilities related to required processes, use, analytics, and improvement initiatives
Manages, directs, and oversees the Quality business strategy, resources, and practices
Drives corporate project and initiative workgroups related to solution evaluations, projects, schedules, enhancements, and fixes
Executes corporate objectives to educate stakeholders on Quality business processes, builds consensus for goals and programs, and shares opportunities for improvements
Benchmarks and evaluates the effectiveness of work processes, operational plans and schedules to achieve the agreed program objectives
Makes critical decisions that capitalize on opportunities for optimization and effect positive change
Provides input to mid- to long-range plans to carry out objectives established by group management
Manages adherence to terms and expenditures related to contracts
Educates internal and external colleagues on relevant systems uses
Provides advice and interpretation of relevant quality regulations and guidance to GQ team
Makes key decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management
Contributes to needed Quality G-SOPs, working practices, and instructional guides
Communicates regularly with key firms to keep current on existing and emerging services and capabilities
Liaises with other business functions and among the Global Quality leads to ensure appropriate representation for systems use, harmonization among similar process, and introductions of creative solutions to meet business needs
Minimum of 10 years of pharmaceutical industry experience
Minimum of 8 years of quality experience and in-depth first-hand experience with GxPs
Minimum of 5 years of service providers contract administration
Minimum of 3 years of international or global project/initiative experience
Expert knowledge of quality systems business uses, including TrackWise, EDMS, Learning Platforms, and audit planning and management
Working knowledge of pharmaceutical industry quality-related laws, regulations, and guidance
Solid understanding of the FDA, EMA, and Health Canada organizations, helpful to have knowledge of other health authorities (e.g., PMDA)
Demonstrated knowledge of regulatory requirements as they relate to user requirements, validation, and data Integrity among GxPs (e.g, GCP, GVP, cGMP, GLP)
Ability to manage and supervise other including managed service providers and vendors
Demonstrated skills in quality & compliance – CAPA programs, participating in audits, SOP programs
Proficient use of Microsoft Office products suite
Results oriented / Innovation: Maintains focus that yields and creative and effective outcomes. Demonstrates the ability to meet goals and targets whether they are individual goals, team deliverable, or the timely completion of duties and projects
Communication skills: Effective in written, spoke and listening activities. Thoughts are conveyed in a clear, concise and timely manner. Must be able to effectively convey complex or difficult information. Listens carefully to understand various points of view and is easy to approach
Problem solving skills: Demonstrates the ability to anticipate and identify core problems, apply insightful analysis, and solve problems effectively. Must be willing to confront tough or difficult issues
Detail Oriented: Demonstrates ability to set and communicate audit goals and standards for Otsuka. Administratively sound in the running of the audit office and meeting Otsuka and industry requirements for reporting. Maintains good records, organized, and timely

183

Manager Global Quality Systems Auditor Resume Examples & Samples

Participate in the creation and maintenance of the risk-based computerized systems validation internal and third party supplier audit plan and contributions to the global audit plan in coordination with the Global Quality Management and Global Product Quality teams, within the audit universe
Manage the computerized systems audits, including planning, supervising, conducting, follow up and support
Manage contract auditors in line with Otsuka’s business model and applicable SOPs
Ensure computerized systems validation audit contributions to other Global Quality team audits as required
Support continuous improvements, such as addressing areas of risk identified from individual audits and lessons learned that can be leveraged globally to assist in corporate risk reduction and inspection readiness
Maintain an understanding of relevant regulatory requirements for computerized systems validation audits and keep informed on relevant changes to ensure information sharing and advice, to enable Otsuka to improve and maintain a computerized system audit program in a manner consistent with these requirements
Support the globalization of computerized system validation audit SOPs (Standard Operating Procedures), where applicable, and in line with company practices and applicable worldwide guidelines and regulations
Assist in Global Quality Systems audit related budget preparation, updates, and management, as well as related contracts
Contribute to local, regional, or global regulatory inspection preparation, participation, and responses, as applicable to computerized system validation
Collaborate with Global Quality to support necessary cross-training for computerized systems validation audit foundational understanding and support on-going efforts as needed
Assist Global Quality Management in establishing corrective action and preventative action (CAPA) management services for Functional teams around computerized system validation audit CAPAs to improve and streamline CAPA closures
Provide data for the Global Quality System computerized system audit metrics and key performance indicators (KPIs), including trends analyses from internal / external audits and lessons learned to advise on risk mitigation plans
Partners with the other Global Quality teams in order to ensure a cohesive and effective functioning model for Global Quality
Supports the onboarding and ongoing training of Global Quality Systems Computerized System Validation Audit personnel (employees and contractors), including access and tool / system uses
Liaises with other external non-Otsuka quality groups as needed
Bachelor’s degree and at least 8 + years professional work experience in audit. A minimum of three years’ experience as a lead auditor
Demonstrated experience in computerized systems audits and audit management
Significant knowledge/understanding of GxP and non-GxP relevant regulations
Preference for experience in performing audits in a global quality environment
Familiarity with FDA, EMA, and PMDA requirements
Strong knowledge of Pharmaceutical industry systems and processes
Excellent knowledge of regulatory requirements as they relate to systems development, validation and data Integrity audits
Demonstrated skills in quality & compliance – CAPA programs, Internal audit programs, SOP programs
Leadership on external audit facilitation and corrective action programs
Results oriented: Maintains focus that yields outcomes. Demonstrates the ability to meet goals and targets whether they are individual goals, team deliverable, or the timely completion of duties and projects
Problem solving skills: Demonstrates the ability to anticipate and identify core problems, apply insightful analysis, and solve problems effectively. Must be willingly confronts tough or difficult issues
Initiative: Must be proactively seeks out and accepts accountability for new and difficult challenges in the field of responsibility
Flexibility: Demonstrates the ability to manage change. Maintains controls for outcomes even when confronted with changes or new direction. Understands that there are often no single right answers
Enthusiasm: Demonstrates a strong desire to accomplish and earn success. Instills a sense of team spirit among peers and team groups. Affects group in a positive manner. Maintains a realistic perspective balanced with strong optimism

184

Senior Analyst, Digital Quality Systems Resume Examples & Samples

Coordinates vendor and cross functional resources to support the delivery of digital systems, including LIMS (LabVantage) to streamline quality operations
Supports the continual improvement of applications and process supporting quality
Participates in validation activities in conjunction with IT, Validation and QA related to implementation and on-going support
Creates/maintains procedures/processes for change requests
Configures/customizes LIMS to support change requests
Conducts user-training sessions for staff members
Performs entry and edit of all relevant static data
Acts as liaison between quality control, internal departments and vendor to address various system issues
Evaluates product enhancements and capabilities, implementing upgrades as required
Triage change requests and assist with daily system administration of QMS, EDMS, and LMS systems
Support initial and routine upgrade system risk assessment and testing activities
Partners with quality unit on system implementation teams and weekly customer calls
Assist in evaluation and revision of departmental policies and procedures as necessary
BS in a relevant IT or scientific discipline with a minimum 5-8 years of experience utilizing LIMS and a minimum of 3-5 years of LIMS administrator experience
Demonstrated working understanding of cGMP and laboratory operations and practices
Demonstrated ability to work independently and collaboratively on cross-functional teams
Strong organizational and/or project management skills
Experience with LabVantage LIMS preferred

185

Supervisor, Quality Systems Resume Examples & Samples

Provides direct supervision of the assigned team through ongoing leadership and guidance
Responsible for keeping inspection procedures and forms current and accurate to current practices using the approved change control system
Performs plant investigation into product complaints and prepares reports for review by the Quality Manager prior to submittal to Corporate Quality Systems. Assists in drafting Material Review Board (MRB) requests to deviate, when appropriate, from current corporate documents
Analyzes processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures. Investigates and makes recommendations to correct and prevent recurrence
Drives process and quality improvements as it relates to the QS department
Determines workload and establishes priorities for the QS department
Conducts on-the-job (OJT) training as required in order to improve the QS department’s efficiency
Serves as the primary contact for personnel issues and staff morale on designated shift(s)
Compiles inspection records, specifications, and other reports and communications as needed
Ensures that certain needs of plant production and distribution are met
Ensures data accuracy and integrity and conducts problem identification, analysis, and corrective action investigations
Evaluates supplier performance through appraisal of the product
Monitors inspection work areas and immediately escalates and/or corrects housekeeping or safety deficiencies
Act as designee for QS Manager in his/her absence or as otherwise necessary
Help to ensure that QS Department is operating within budgetary constraints
Provides technical guidance
Frequently interacts internally with subordinates and other supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules and basic problem resolution
Administers company policies, processes and procedures that directly affect subordinate employees and the workflow unit. Recommends changes to unit or sub-unit policies
Works on issues where analysis of situation or data requires a review of relevant factors. Exercises judgment within defined procedures and policies to determine appropriate action. Role primarily focuses on tactical execution
Provides direction to employees, according to established policies, procedures and management guidance. Supervises day-to-day operations of employees. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations
Completes other duties as assigned
At least 2-4 years of experience in Quality Assurance and/or Quality Control in a manufacturing environment; includes at least 2 years of supervisory experience
Experience in the medical device, pharmaceutical, or related industry is strongly preferred
Excellent intrapersonal skills and ability to develop positive relationships at all levels of the organization
Above average written and verbal communication skills
Ability to work cross-functionally
Strong PC skills with MS Office Products, including but not limited to Word, Excel, Visio, and PowerPoint

186

Project Engineer Quality Systems Resume Examples & Samples

Take ownership of the development, implementation, and maintenance of consistent external standards management policies, procedures and practices
Provide consistent identification, application, and interpretation of standards across the Product Supply organization; ensuring that products/processes conform to market access requirements
Lead the Standards Management team, ensuring that the team provides the following support to the organization
Bachelor’s Degree in a technical discipline with a minimum of 7+ years of experience, preferably in Medical Device Manufacturing and/or Quality
Thorough understanding of the application of standards in a regulated environment
Particularly extensive knowledge of FDA QSR and ISO Quality Standards
Knowledge of Computer Systems Validation regulations and 21 CFR Part 11 requirements
Knowledge of software and paper-based Data Integrity principles in FDA regulated environment
Extensive experience at the development and execution of cross functional projects
Core Competencies: Strong leadership skills; deal effectively with changing situations; Power to motivate self, make timely decisions, improve results, persist despite opposition and obstacles; Express ideas and information, orally and/or in writing, in a clear, concise and understandable manner, use active listening skills; Be able to guide and train teams; Self-motivated/self-directed/self-learner; Ability to handle multiple priority items at the same time
Bayer Competencies: Drives Results, Plans and Aligns, Strategic Mindset, Builds effective teams, Manages Ambiguity

187

Corporate Quality Systems Software & Application Developer Resume Examples & Samples

Manage the development, maintenance, and implementation of InfinityQS world wide
Develop and maintain applications to assist in data collection
Provide Special reports and access to the system data for other applications or business functions as needed
Responsible for providing the quality tools for continuous improvement
Assist in meeting departmental budget

188

Senior Quality Systems Associate Resume Examples & Samples

Review and approve internal investigations (deviations, OOS); lead or manage open investigation and consult for internal GMP functions
Manage change control system Manage GMP training program
Develop and manage continuous improvement program including CAPA, quality plan Collaborate with EU QA and CMC personnel on systems related data
Support data management and reporting for the Avid quarterly management review Plan and lead corporate audit /regulatory Inspection
Bachelor’s Degree in Pharmacy or other discipline relevant to drug discovery, development, or commercial products
5+ years of Quality Systems/Assurance experience in a regulated environment such as GMP or ISO
Knowledge or experience in aseptic processing environments and analytical testing, e.g
HPLC, GC, residual solvents, impurities, sterility and endotoxin testing. Parenteral therapeutic drug development experience is strongly preferred
Strong knowledge of relevant regulations of US and European drug GMPs, ISO a plus Knowledgeable in Quality Management Systems (FDA or ICH approach to risk management and QMS)
Working knowledge of third party manufacturing and contracts preferred Experience in compilation and review of Annual Product Reviews (APRs)
Demonstrated ability to write and provide a thorough QA technical review of root cause investigations, OOS, and complaints
Experience with electronic quality systems such as EDMS or Regulus, TrackWise, SuccessFactor or ComplianceWire
Ability to work independently and escalate issues (notification to management), when necessary
Meeting facilitation and project management skills
Ability to simplify complex processes/problems and propose alternate solutions Ability to identify and manage risks to project timelines

189

Senior Quality Systems Processor Resume Examples & Samples

Quality Engineering & Validation support to analyze and improve the manufacturing of the various products in this facility
Develop, review and/or execute Validation Protocols & Plans for the facility
Maintain & follow up on Quality & Validation Corrective Action Plans. Perform Internal & External Audits of Facility & Supplier Quality Systems. Provide Progress Reports to management to show product quality levels and facility validation progress. Contribute to the continued adherence to the cGMPs & ISO 9000 standards
Assess proposed measurement and test equipment to make certain that it meets the requirements for intended use
Provide Quality Engineering & Validation support to Manufacturing for changes to manufacturing equipment and/or processes
Provide Quality Engineering & Validation support to Manufacturing in the development of new processes and products
Occupational Demand Requirements: Position may require standing, walking, kneeling, twisting, driving, writing, talking, sitting, bending, climbing ladders/steps, handling, turning, stooping, balancing, carrying, grasping, use both feet, use both hands, reaching 12 in., pushing 50 lbs., pulling 50 lbs., lifting 50 lbs., lowering 50 lbs., reading, problem solving, verbal communication, reasoning, negotiating, written communications, customer contact/general public, math calculations, deadlines under pressure, learning/retaining technical information, interface with FDA & Regulatory Auditors, consult as critical process expert, exerting up to 20 lbs. of force occasionally, or 10 lbs. frequently to move objects

190

Quality Systems Resume Examples & Samples

Manage Quality Systems for Global Electronics
Responsible for TS 16949, ISO26262 adherence and compliance
Responsible for successful maintenance of TS Certification
Coordinate ISO/TS activities in manufacturing locations and other related design centers for Global Electronics
Conduct VDA Audits at design centers and manufacturing locations for Global Electronics
Conduct Line Readiness Audits, PMA, and LPA as needed
Understand and ensure compliance of ZF TRW systems to customer requirements and business needs
Alignment of PMA, LPA across Global Electronics
Follow up and closure of any actions, open items involving cross functional teams as needed
Maintain Lessons Learned Read Across Database
Assist in problem solving activities across product lines to maintain customer satisfaction
Certified TS personnel well versed in AIAG, IATF (TS/ISO) requirements
Knowledge in VDA systems/ Requirements. Certified personnel Preferred
Experience in establishing and maintaining Quality Systems in Automotive environment
Knowledge in Shanin or RedX problem Solving techniques. Certified personnel Preferred
Electronics product knowledge or background preferred

191

Quality Systems Supervisor Resume Examples & Samples

2nd Shift
Actively engaged support in planning, defining and directing the site auditing control program to ensure compliance to all procedures, and policies, GMP standards, Kraft Heinz requirements, and regulatory, federal and local laws
Participate in the QRMP audit and assist with the development of procedures and follow up on corrective actions as assigned
Support the QRMP system and operational standards as outlined in the plant accountability list
Trains, mentors and leads site QA and Production team to insure program goals are met. Strong support to site QCMS/ISO Coordinator. Monitors and maintains plant QCMS/QRMP program by complying to current Kraft Heinz and International Audit (FSSC/ISO) standards. Facilitate and co-lead site cross functional QCMS/QRMP Team and participate with Kraft corporate to insure successful certification for site
Annually verifies all HACCP plans or when required due to project changes
Support all internal and external inspections/regulatory visits. Support audit preparation activities, accompany inspector, and complete necessary reports and postings
Perform follow-ups to non-conformances found and provide responses as appropriate. Review and approve minor change requests
Insure proper construction procedures are followed to meet site/client safety requirements. Takes appropriate steps to assure successful project startups
Responsible for Hold/Release documentation and dispositioning of products
Responsible for maintaining/validation/continuous improvement of all laboratory testing and equipment
Facilitate plant sanitation
Bachelor's Degree in Food Science or equivalent degree, preferred
Minimum 2 years of experience in a quality and/or technical leadership role or minimum 2 years of experience in operations/quality/technical (R/D)
Strong leadership, technical, communication and organizational skills required along with attention to detail
Advanced knowledge of quality systems, procedures, & policies helpful. Handle multiple assignments, develop work plans, & prioritize
Knowledge of statistical processes
Detailed-oriented
Effective communication skills (oral written and verbal)
Planning and organizing skills
Successful candidates must possess a positive focus toward solutions with emphasis on preventative pro-active measures and team-building
Must be able to work 2nd shift, weekends, and all required overtime. Prompt and regular attendance

192

Quality Systems Supervisor Resume Examples & Samples

Above all, ensure a safe work environment while complying with environmental and quality rules and policies (ISO14001, IATF 16949, MIOSHA)
Provide supervision to personnel within the Quality Department. Effectively guide the training and development of staff by implementing a team philosophy while improving individual accountabilities through clear goals and objectives
Administer quality alerts for returned material and ensure corrective actions are assigned and tracked
Support comprehensive Quality Management and Quality Operating System Strategy
Support APQP process on all launch activities and successful PPAP to the customer
Ensure quality system adheres to appropriate standards as deemed necessary by management (i.e. IATF 16949, ISO14001). Support and conduct internal and external system, process, and product audits related to IATF 16949 and ISO14001
Lead for Change Management System, layered audit process, and BorgWarner Global Star Safety Framework (GSSF) program evaluation
Act as Environmental Management Representative which includes ensuring the environmental management system conforms to the requirements of the standard, proposing environmental objectives, scheduling audits and reporting results, and completing government reports as required
Lead and support continuous improvement initiatives (quality, cost/scrap, delivery, etc.) and corrective actions. Work with Product Quality to establish and sustain prevention-based controls to assure both internal and external customer satisfaction
Develop a culture of quality improvement through education and communication with all levels of staff within the organization. Train and educate team members on quality controls and systems
Bachelor’s Degree in an Engineering or Quality Discipline
Five (5) years quality assurance and supervisory experience required; Ten (10) years preferred
Five (5) years of experience in manufacturing process, systems and tools, including
Statistical methods
FMEA, APQP, PPAP, Process Flow, etc
Problem Solving Methodologies (5-Why, 8D, etc.)
Three (3) years Quality Assurance experience, encompassing development of QMS documentation, working with PPAP processes, and supporting/leading formal problem solving groups
Experience and working knowledge of ISO Quality Management Systems (ISO 9001 and/or IATF 16949), including leading internal and external audits of each system
Experience working with environmental systems is required
Excellent attention to detail and organizational skills to prioritize and carry out multiple projects
Advanced proficiency in Excel

193

Quality Systems Consultant Resume Examples & Samples

Experience with Relational Database concepts and design
Serves as project team member on EtQ Reliance related projects and performs advanced configurations in EtQ Reliance using EtQ Reliance Designer, Python, EtQ Reliance script, SQL, JSP, and HTML scripting
Configure automated test script using EtQ Reliance eValidator or create manual test scripts, execute tests, and document results as dictated by Computer System Validation (CSV) principles
Successful candidate should be able to troubleshoot and leverage documentation to solve problems
Ability to learn quickly and work with a variety of personnel is essential
Ability to manage day-to-day and project priorities
Ability to document configurations, create work instructions, and Quick Reference Cards (QRCs)
Experience with creating/altering SQL queries
Experience editing HTML files
Working knowledge of 1 or more programming languages
Process oriented, i.e., ability to follow and improve standard work
Ability to work well in a team-based environment
Strong organizational and time management skills Desired Skills
Medical Device Quality Systems experience
Experience with MS Excel and MS Word

194

Quality Systems & Documentation Specialist Resume Examples & Samples

Initiate and administrate workflows in Oracle Agile system upon receipt of revision requests for all controlled document types (SOPs, forms, Quality Standards, Specifications, BOMs)
Issuance of revised documents including archival of superseded documents. Initiate routine document review workflows for controlled document types (SOPs, forms, quality standards)
Maintains training record, administrate training assignment resulted from change control. Create and maintain training matrix. Support other training processes as needed
Review and approve production and quality control Batch Records. Perform batch release including: labeling, ERP transactions, document control, filing and other related tasks
3+ years of related work experience in quality assurance, document control, data entry and office administration
Knowledge of ISO9001 or 13485 document version control processes, policies and procedures
Ability to work independently or as part of a team, self-motivated, adaptable
Experience with Oracle Agile PPM, Spartan TrackWise, SAP ERP/QM/LMS or other major electronic QMS tool highly desired
GMP Quality Assurance experience highly desired
Bachelor’s Degree a plus

195

Divisional Quality Systems Audit Leader Resume Examples & Samples

Be passionate about providing support for state-of-the-art implantable medical devices
Being the Gore point of contact for external auditing bodies and providing primary leadership for all external audits
Defining the support structure to enable consistent and successful inspections depending on the scope of the audit, i.e., engaging local Regulatory, Quality, and other functional subject matter experts to connect site/function centric activities with expectations, goals, and overall audit support strategy
Identifying applicable standards and regulations for inspection and ensuring expectations are understood by supporting teams, as well as performing mock audits and training where needed
Ensuring effective and timely responses to any non-conformances including engaging external consultants when needed
Communicating audit support objectives and results to the Medical Products Division leadership team
Ensuring logistics support inspection needs
Implementing industry aligned best practices and continuous improvement for audit support, including defining and measuring key indicators of success
A bachelor’s degree in Engineering or Science
At least ten years of experience in quality or regulatory systems support in the medical device or pharmaceutical industries with a record of increasing responsibilities
Direct experience hosting, leading and responding to external regulatory audits in the medical device or pharmaceutical industries
Successful track record of leading through influencing
Five years of experience formally leading teams
Experience engaging external consultants to build capabilities while ensuring fit in the current quality system/organization
Professional Quality affiliations and certifications

196

Quality Systems Senior Analyst Resume Examples & Samples

Facilitates and / or provides support for all application users, including training and trouble shooting
Act as technical expert for system requirements and updates
Ensure systems are available, globally 7x24. Includes troubleshooting and problem resolution
Support activities for process and system improvements, focusing on compliant, yet lean initiatives
Manage and confront issues as they arise
Formulate cross-functional teams, gaining consensus of requirements and approach
Prepares and assures completion of required personnel training
Proactively works to ensure automated systems related to quality systems meet or exceed all applicable regulations and standards
Support Teamcenter PDM/PLM application administration including user management, security, workflow and web client maintenance
Ideally possesses a broad business perspective, including understanding the processes used within the respective areas, project management and Zimmer business goals of cost, quality and customer satisfaction
Must work well with others and interact effectively with all levels, outside contacts and support personnel
Must be creative in solving problems with new products to maintain scheduled completion dates
Must possess an understanding of GxP regulations, state of the art validation techniques
Must be able to develop, implement, and execute system protocols
Requires an understanding of process, equipment, software, and infrastructure, with an emphasis on software
Requires knowledge of Systems
Bachelor’s degree in computer science or an appropriate engineering discipline
A minimum of one year of experience supporting applications is required
Familiarity with Good Manufacturing Practices and QSR/ISO standards required
5-7 years plus professional work experience required

197

Specialist, Quality Systems Document Control Resume Examples & Samples

Maintain a document management system compliant with regulatory, quality, and Kite requirements
Responsible for the management of all documentation and records issuance and archival processes to support clinical and commercial manufacturing
Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system
Executes the document change process so that only approved and validated changes are incorporated into effective product and process documentation
Support audits (internal, external) in order to verify that regulatory and quality requirements have been met

198

Quality Systems Supervisor Resume Examples & Samples

Minimum of three (3) years Quality, Regulatory, Laboratory, and/or Manufacturing Engineering experience
Bachelor’s degree or higher in Manufacturing/Industrial Engineering, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Statistics/Mathematics or related discipline from an accredited University
Proficient knowledge of and experience working with quality systems applied to the health care industry (FDA Drug GMP and QSR, Medical Device ISO 13485) with focus in validation, manufacturing, quality control labs, and facility requirements
Excellent verbal and written communication skills. Ability to write clear, concise, and well thought out technical documentation
American Society for Quality, Certified Quality Engineer (CQE) certification or willingness to obtain
Knowledge of systems, such as CFRS, ISM, e1M, eMatrix, QPID, DPQ, etc. (applies to internal applicants only)
Proficient in MS Office (Word, Excel, PowerPoint, Access) and writing/using data queries, extracts and analysis

199

Senior Specialist Quality Systems & Compliance Resume Examples & Samples

Quality review and approval of Deviations and CAPAs associated with Vaccine Manufacturing Facility and presenting investigations during regulatory inspections
Assist management in the tracking and monitoring of the Deviation/CAPA and Complaint/Adverse Event Management Systems. Perform quality checks to ensure accuracy, completeness and proper usage of data. Prepare and/or review activity, progress, and performance metrics reports
Assist in the reporting and assessment of critical data by indexing, archival, and retrieval of Deviation/CAPA and Complaint/Adverse Event System data
Participates in and/or leads Lean Six Sigma process improvement projects
Responsible for development, implementation, and management of CAPA effectiveness program
Responsible for identification of trends, ongoing monitoring of the system, and providing recommendations for continuous improvement
Serves as Subject Matter Expert (SME) for areas of responsibility
Perform SOP development and review / Quality approval
Direct support of regulatory inspections and audits; defends Quality Systems, Deviations, CAPAs, Complaints, and Adverse Events during regulatory inspections
Provide daily maintenance, review and oversight of Deviation Management/CAPA and Complaint/Adverse Event System data throughout the document lifecycle
Perform data analysis and metrics to ensure quality of the Deviation/CAPA & Complaint/Adverse Event Management System programs
Assist in evaluating existing Deviation, CAPA and Complaint/Adverse Event systems on the global and local level and assist in the implementation of consistent management process across the site
Perform Quality System Audits or GMP walk through audits
Change Control approval
Assist in Permanent Inspection Readiness (PIR) projects
Support Annual Product Reviews
Support of Biological Product Deviation Report ( BPDR) submissions to FDA associated with PQC, AE, or site Significant Deviations
Investigation of Product Quality Complaints (PQC) and Adverse Events (AE)
Quality review and approval of Automation Incident investigations
Minimum 5 years of experience within in the Pharmaceutical industry in Quality, Technical, Manufacturing Operations, or related Business Operations working with Deviation Management, CAPAs, Product Quality Complaints, and Adverse Event investigations
Experience performing review and approval of Deviations and CAPAs
Knowledge of cGMPs, data management collection and analysis
Proven expertise of cGMPs, technical writing, data management collection and analysis
Demonstrated Quality, Technical, and / or Manufacturing experience in the areas of Deviation Management, CAPAs, Product Quality Complaints, and Adverse Event investigations
Ability to interpret complex business and/or technical documents, write comprehensive reports and detailed business correspondence, and the ability to present to groups across the organization as needed
Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices, and systems
Demonstrated innovative mindset
Demonstrated cross cultural agility and resourcefulness
Proven expertise with Lean 6 Sigma methodologies
Significant experience in biologics, vaccines, and/or biopharmaceuticals compliance
Experience as Subject Matter Expert (SME) in presenting to regulatory agencies
Knowledge of Automation and ERP / Quality Data Management systems such as SAP, Trackwise, MIDAS, Emerson DeltaV, Allen Bradley PLC (or equivalent), MES (Manufacturing Execution System), and automated inspection systems
Quality Auditing experience

200

QA Specialist, Quality Systems Resume Examples & Samples

Product and supplier development activities
Logging of customer complaints
Respond to customer inquiries, retrieve and generate customer requested documentation
Basic MasterControl functions
Must have good organizational and communication skills
Must be able to effectively communicate in English (oral and written)
Basic knowledge and understanding of cGMP, Quality Standards, Requirements, and Specifications (ISO, ANSI, FDA, etc) a plus
Experience with 21 CFR 210 and 211 a plus
Experience with MasterControl or other quality system software a plus

201

Quality Systems Program Manager, Vista Resume Examples & Samples

Take the lead in the implementation of one of the programs of the Quality System and become the specialist for that system
Assist with creation of shared Quality Systems documents for company to achieve harmonization between the south Los Angeles and Vista sites
Assist with implementation of Master Control software in company's San Diego and south Los Angeles locations
Assist with internal auditing at both sites
Maintain professional relationships with supervisors, direct reports, employees, suppliers and appropriate others
Ethical representation of the company in all activities
Oversight of all compliance matters within the department

202

Senior Quality Systems Auditor Resume Examples & Samples

A seasoned, experienced professional with a full understanding of quality systems auditing, schedules, plans, conducts, and leads audits in accordance with the Corporate QS Audit Program
Acts as a subject matter expert. Ensures audit activities are in compliance with company procedures and regulatory requirements
Disseminates audit findings to senior management as required by the Corporate QS Audit Program
Provides extensive regulatory expertise as needed to support QS improvement initiatives
Develops and creates audit reports, coordinates action plans, and follow up with auditee to assure prompt and adequate completion of agreed upon actions
Establishes and conducts sectional readiness training for FMC RTG sites and QS functions
Serves as GMP subject matter expert (SME) for regulatory inspections, as needed
Creates, revises, develops, and reviews standard operating procedures used for GMP auditing
Performs any other tasks as requested by Management to support quality oversight activities
Helps development and reporting of quality and compliance metrics related to Compliance audit activities
Leads contracted 3rd party audit activities used for supporting the Corporate QS Audit Program
Establishes/maintains effective cross-functional team communications to advance FMC quality activities
Minimum 5 - 8 years of GMP auditing work experience in the medical device, pharmaceutical, or biotech industry. Experience in medical device or pharmaceutical R&D or manufacturing (experience outside of auditing) desired
With a Master’s Degree minimum 3 years of experience required
Extensive knowledge of good manufacturing, strong understanding of FDA/ICH regulations and Quality Systems; Solid background in Quality Assurance/Systems
Outstanding auditing skills and attention to detail with audit program implementation including interpreting regulations, guidelines, and identification of compliance issues
Demonstrated broad expertise related to the principles and application of quality and regulatory compliance
Demonstrated ability to effectively communicate and influence the outcomes of the decision making process
Displays highly developed organizational leadership qualities and effective coaching abilities
Listening, interpreting, and summarizing information skills must be highly developed
Excellent communication and writing skills; Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
Ability to work both independently with direction and within project teams to attain goals
Expertise in reviewing, revising, and writing Standard Operating Procedures (SOPs)
Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)
Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines

203

Quality Systems Coordinator Resume Examples & Samples

Ensure that the processes needed for quality management system are established, implemented and maintained
KPM & Internal action validation on the floor ensuring updated to documentation such as Control Plan, FMEA, ODS and WI
Review WIs, and Procedures periodically to ensure that we are compliant. When applicable assist with the creation of new documents mentioned
Attend regular internal change controls meetings
Leads internal and external VDA & IATF 16949:2016 audits activities as well as ensuring yearly compliance
Has the ability to prepare documentation report (VDA, IATF16949:2016)
Understands and has the ability to promote the awareness of customer requirements throughout the organization
Conduct and management of our internal VDA & TS Audits as required
Upkeep and maintain our SharePoint database and all other relevant databases (System Documentation)
Responsible for Document Control. This includes monitoring documents, assigning document numbers, retention, etc
IATF16949:2016 Element champion as required
IATF16949:2016 Representative
IATF16949:2016 Lead Auditor or Internal Auditor as required
Development of Control Plan (including receiving Control Plan) and making sure there is alignment with the PFMEA
Graduate of accredited university/college in engineering, technical or business (bachelor’s degree), preferred
Experience in audits and documentation

204

Director, Global Quality Systems Resume Examples & Samples

Must be able to recognize and direct resolution of Quality issues and compliance risks
Must complete tasks independently, direct lower level managers and professionals, decisively make tactical and strategic decisions within the department, contribute to strategic decisions within Quality and set priorities for the department
Must be skilled in strategic thinking, managing through systems, navigating politics, innovation management, and negotiation
Must possess a strategic perspective, leading vision and values, global acumen, and a leadership disposition
Must have strong mentorship and coaching skills focusing on the development of future organizational leaders
Function as the accountable business owner for GMP modules in the eQRMS system, mainly, PQC, Change Control, CAPA and Deviation, as well as QUADS
In conjunction with the Executive Director, Global Quality Systems, shape the strategic direction of GMP Systems through ownership and implementation of the technology roadmap for eQRMS GMP modules and QUADS including lifecycle changes and system level enhancement
Serve as liaison for the eQRMS system representing the GQS team in strategic governance activities
Ensure an effective training program including content , tools and methods are appropriately deployment across the respective GMP user communities
Collaborate with cross-functional GMP partners including but not limited to Technical Operations and Pharmaceutical Development, to ensure new and emerging needs are identified up-front and planned for on the system roadmap and in collaborative goals and objectives
Supervise all relevant Quality System owners
Champion the standardization and harmonization of processes, techniques and tools across the GMP space
Collaborate with 3rd party partners in the implementation and life-cycle management of the Quality Systems
Continuously develop and provide mobility for leaders within Celgene while ensuring a robust pipeline and succession plan

205

Senior Quality Systems Auditor Resume Examples & Samples

Lead and/or manage audits and inspections
Help to develop the corporate internal auditing function, processes and procedures
Lead quality system audits to ensure the Global Quality Management System operates in a state of compliance and continuous improvement
Perform audits across the Medical Devices organization, performing mock FDA audits and due diligence work where applicable
Document audit reports within specified time frames and generate audit corrective action requests as applicable
Follow, interpret and create written Policies and Standard Operating Procedures (SOP’s)
Monitor non-conformances, perform trend analyses, and present findings
Contribute to the development and improvement of audit program metrics
Report systemic quality system issues through the analysis of quality data such as CAPAs, complaints, MDR/Vigilance reports, audit reports and other relevant data
Provide or communicate input to Corporate Risk Management and Global Trade Compliance
Involvement in Corporate CAPA (Corrective and Preventative Action) projects
Help to interpret and disseminate information on new or changing regulatory requirements
Manage suppliers and vendors
Minimum 10 years’ experience with quality assurance or quality systems in a regulated (FDA) industry, applying quality system regulations and quality standards, and performing quality system audits
Bachelor’s degree required in Sciences program (Microbiology, Electrical Engineering, etc.)
Certified Quality Auditor (CQA) certification required; Lead Assessor Certification Required
Pharma auditing experienced preferred
5+ years’ experience in auditing for medical devices, drug and biologic engineering, etc
Demonstrated understanding of industry regulations, including detailed knowledge of FDA QSR’s and ISO 13485
Persuasive and able to lead through influence
Ability to operate and use computers
Must possess sound organizational skills, demonstrate attention to detail and an ability to multi-task
Total Quality Management process experience
ASQ Certification or Equivalent
Project Management experience a plus
Must be able to travel approximately 70% of the time
Must be able to challenge the status quo, influence others and encourage collaboration to resolve issues
Must be able to identify customer needs and issues and develop realistic solutions to meet the needs of the business
Must be able to make rational, objective, and appropriate decisions relating to company needs

206

Quality Systems Spec Resume Examples & Samples

2+ years’ experience in documentation management with Bachelor’s degree
0+ years’ experience in documentation management with Master’s degree
Working knowledge of Microsoft Office tools, desktop publishing software experience, familiar with ISO 9001 / ISO 13485 quality systems
Familiarity with modern ERP systems, PLM systems and manufacturing documentation (i.e. BOMs, item masters, etc.)
Degree in science or engineering
Experience working within a technical environment
Strong interpersonal communication skills
Office Skills: telephones, word processing, data entry, spreadsheet (PC), ERP software, and database systems,
High capacity to multi-task; energized and self-actuated
The employee must frequently lift and/or move up to 20 pounds
Occasionally exposed to humid conditions because of air conditioning units used to control the building environment
The noise level in the work environment is quiet to moderate

207

Quality Systems Spec Resume Examples & Samples

Academic level
Confirmed knowledge of document management system “Documentum” “Agile” or equivalent
Bilingual in French
English proficiency for fluent communication with US partners (verbal and written)
At least a 3 years’ experience with a QMS in a medical device or pharmaceutical business at a quality position
Knowledge of standards and regulation (ISO13485, ISO14971, 21CFR820)

208

Quality Systems Coordinator Resume Examples & Samples

Collect, organize, monitor, and communicate information and reports related to the Management System and process improvements
Manage document and data control systems as applicable
Internal audit program management
Coordinate third party audits with certification body and Group Management Systems Coordinator
Lead/participate in internal and 2nd party audits
Provides administrative assistance to Quality department as requested
Data entry, creating, filing, organizing and communicating documents as required
Champion Diversity & Inclusion in line with the Company guidelines
Other duties as directed by the Quality Manager
AS in Technical or Business and 1 year experience as a Lead auditor with process and quality audits and/or administrative skills or 5 – 10 years of equivalent experience
Experience with TS 16949 Standards and Customer Specific Requirements

209

Quality Systems Senior Engineer Resume Examples & Samples

CAPA Administrator and acting as resident Expert for CAPA
Administration / follow-up of CAPA, including but not limited to the monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions and VoE
Carrying out internal trainings for CAPA
Monitor the Effectivity of the CAPA system, trend CAPA
Report CAPA related metrics, present CAPA information during Management Reviews
6 years’ experience in a quality organization of a manufacturing industry (preferably medical devices or pharma)
Knowledge of applicable Regulations and Standards, in particular ISO13485, ISO14971, the Medical Device Directive 93/42/EEC, US Quality System Regulations (QSR) and Canadian Regulation (CMDCAS)
Auditor training with Diploma examination is preferred
Good problem-solving ability and analytical skills, strong sense of initiative, follow-through and attention to detail
Can conform to shifting priorities, demands and timelines
Flexible during times of change
Familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel, SAP and MS Project and able to learn new technologies quickly
Excellent command of English and German both verbal and written

210

Specialist, Quality Systems Resume Examples & Samples

Reviews and assesses product complaints including identifying trends, adverse events and determining the need for investigations
Works cross–functionally to perform and document product complaint investigations in a timely manner
Creates clear and concise investigation reports, which may include graphs and charts
Coordinates cross-functional teams in order to facilitate process improvements to reduce complaints
Facilitates and follows up on Root Cause Analysis and Corrective and Preventive Actions (CAPA)
Processes returned consumer samples as required
Creates response letters pertaining to investigation findings for consumers, customers and for regulatory reporting as required
Provides ongoing support for the Quality Systems team and day to day activities to ensure department goals are achieved
Supports continuous process improvements as guided to support current business and future growth
Knowledge of quality control principles and cGMP regulatory requirements for foods and dietary supplements preferred
Familiarity with manufacturing systems and processes
Associates or Bachelor’s degree preferred. Appropriate experience within a manufacturing environment or other closely related discipline experience can be considered in lieu of a degree
Familiar with FDA regulatory requirements and dietary supplements
The ability to function effectively as a member of a cross- functional team is required
Ability to work in a fast paced environment and deliver results on time
Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)
Good communication and documentation skills
Analytical thinking/ problem solving

211

Manager, Global Quality Systems Resume Examples & Samples

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Extensive experience with design, implementation and continuous improvement of electronic technology solutions
Ability to serve as enterprise wide subject matter expert in the area of quality and compliance requirements for IT systems
In-depth knowledge of international regulatory directives (FDA, EMA, MHRA, PMDA, QSR, ICH, PIC/S) and Risk Management principles with the ability to interpret and apply requirements
Strong customer focus, both internally and externally and must be able to build/maintain relationships with key stakeholders
Proven ability to work effectively with cross-functional stakeholders in a complex, changing global environment
Able to communicate effectively within the job function and with internal and external cross functional teams
Ability to work proactively and independently with the ability to make decisions within the subject matter area
Demonstrated negotiating and interaction skills in internal and external cross-functional teams
Demonstrated critical reasoning, problem-solving and decision-making skills
Demonstrated resource management and planning skills
Demonstrated oral and written communication skills including presentations to senior management and external organizations
Prior experience with relevant systems such as document management, ERP, training management and lab systems
DUTIES AND RESPONSIBILITIES
Relevant college or university degree
5-7 years’ relevant work experience; minimum 5 years of project or people leadership experience; equivalent combination of education and experience acceptable
WORKING CONDITIONS: (US Only)

212

Regional Quality Systems Training Coordinator Resume Examples & Samples

Ensure that Training processes are in alignment with Consumer Sector procedure and Enterprise standards
Working with all functions to ensure on-time training metric is consistently delivered across the EAME region. Duties include monthly collection, review & reporting of training metrics and effectiveness, together with responsibility to ensure routine (weekly) pre-emptive and follow-up of on-time time training with trainees across the region
To be the regional lead and SME for Training process as per global procedure and playbook and provide associated process, training and support across the region
To be the regional lead and SME for the Consumer eLearning Management System, and first regional point of contact with local eLMS admins for all application administrative aspects including process, configuration, functionality, issue resolution and, if necessary escalation and resolution with global eLMS application owners
Propose, identify, communicate and implement as needed new or revised Training processes or applications for the region to ensure continued compliance with global regulatory standards and new/changing regulations pertaining to training requirements
Responsible for Training standardization within Consumer across regions. Collaborate w/ Enterprise on standardization initiatives and deployment of new IT solution/process within Consumer
To be the point of regional point of contact for
Coordinator: At least three (3) years in the field of Quality Systems and Compliance within regulated medical industry
Regulatory inspection experience highly desirable
Track record of successful cross functional partnership and experience of highly matrixed organizations
Track record of resolving compliance issues
Working knowledge of applicable international healthcare, medical device and cosmetic regulatory requirements for Quality Issues Management within regulated healthcare industries
Excellent written, verbal and presentation communication skills
Excellent Training skills
Must be able to develop and maintain relationships/partnerships and to work collaboratively both internally and externally
Experience of eLMS systems
Change management and Project management experience
Excellent MS Office and Office 365 skills
Highly organized and willing to undertake significant responsibility whilst also undertaking a significant amount of routine administrative duties
Self-starter, objective driven and confident to work remotely without daily supervision/oversight

213

Quality Systems Technician Resume Examples & Samples

Undergraduate degree required in Industrial Engineering (Preferred)
2 years’ experience in similar position
Fluent in English (Written/Spoken)
Knowledge in MS Office, mainly Excel & Power point
ISO 9001 experience, knowledge
Internal audit experience

214

Lead Quality Systems Document Control Coordinator Resume Examples & Samples

Upholds departmental standards as required in a GMP environment
Manages workflow of manufacturing batch records for optimum productivity
Maintains schedule of rotating department tasks and assigns daily work assignments to team members
Reviews manufacturing and customer facing documentation for accuracy to support timely release
Processes final release of product according to quality control release standards
Interacts with cross functional internal customers at all levels of the organization for resolution of issues
Generates and presents detailed reports for continuous improvement metrics
Provides feedback and coaching to team members on daily work tasks
Multi-tasks efficiently in a high-paced environment
Focuses on team objectives to meet customer expectations
Supports training and cross-training efforts for team development
Provides training for new hires and designates
3-5 years of work experience in a direct Manufacturing setting or combination of experience and education
High School Diploma required
Possesses effective communication skills both orally and written
Excellent computer skills, display specific expertise in Excel
Bachelors’ degree in Managerial or Business related studies
Behaviors including: problem solving, professional demeanor, multi-task capabilities in high paced environment, motivational and team building skills, presentation and training skills, and delegation skills
Ability to work independently and in a group setting with little direction

215

Quality Systems Team Leader Resume Examples & Samples

5+ years of quality systems experience in a manufacturing environment required, Aerospace industry experience preferred
Working knowledge of the investment casting process a plus
ISO 9001/AS9100 Lead Auditor training highly desirable
Six Sigma Green Belt Certification preferred
Ability to communicate well at multiple levels; Strong verbal and written communication skills
Aerospace industry experience is preferred
Ability to interpret & implement standards and requirements
Must have effective interpersonal, project management, basic computer, communication, problem solving, leadership and analytical skills
Registrar’s Accreditation Board (RAB) certification also a plus
Thorough understanding of ISO 9001/AS9100 quality management system standards (current revisions)
Ability to analyze and interpret data from various processes and/or departments to identify gaps and nonconformities
Ability to tactfully and confidently interface at all organizational levels
Strong understanding and experience in Root Cause Analysis & ability to train in the concepts when required
Basic understanding of Nadcap special processes and their applications within the manufacturing environment
Strong understanding and hands-on knowledge of BU level data collection and analysis systems

216

Quality Systems Team Lead Resume Examples & Samples

Responsible for the consistent and correct execution of QS global procedures within the site to ensure the quality and compliance of processes and records for CAPA, Customer Complaints Investigations, QPR and QSMR and Field Action Investigations
Develops competency of resources within the site that execute CAPA, Customer Complaints, QPR and QSMR, by providing training and guidance on the execution and documentation of these processes,
In partnership with the site Quality leaders, oversees the timely and compliant execution of site CAPAs, Customer Complaints, QPR and QSMR, by championing collaboration across functions and sites and developing action plans, as required, in order to improve or sustain associated metrics at target levels
Leads a governance process to ensure flawless execution of site QPRs and QSMRs according to global procedure requirements
Oversees the timely site collection, escalation and reporting of all Quality System metrics to management
In partnership with the site Quality leaders, oversees the Product Escalation process for non-conformances, complaints or other issues potentially impacting product in the field. Reviews related investigations and corrective action plans to avoid recurrence of the nonconformity. Ensures timely closure of escalations
Identifies needs to meet and improve system performance of CAPA, Customer Complaints, QPR and QSMR at the site level, and escalates to appropriate representative and management in a timely manner
Collaborates with The Regional Quality System Leader in the deployment of QS initiatives impacting the site that promote the continuous improvement of the QS and ensure continuity of the application of globally shared processes and systems at site level,
Supports compliance activities by participating in audit readiness; assisting in Internal and External audits; serving as Subject Matter Expert for CAPA, Customer Complaints, QPR and QSMR during audits; managing the investigation, response, and remediation of site-specific QS audit observations
At a minimum, BS degree in Engineering / Scientific or associated relevant technical / Quality discipline is required
Five (5) years related experience in Medical Device or Pharmaceutical environment or other highly regulated environment is required
Experience with CAPA, Nonconforming Materials, and Complaints is required. Experience with Management Review and Field Action investigations is preferred
Experience with root cause investigation and process management is required
Direct Supervision experience with training or coaching others is preferred
Strong communication, influencing and leadership skills: ability to communicate at all levels of the organization, and to interact with and influence cross-functional and cross-business teams to drive results is required
Strategic and tactical execution abilities, including strong organization skills is required
The ability to take initiative regarding innovative approaches to problem solving in a fast-paced, changing business environment is required
A certification in process excellence preferred
This position will be based in Elmira, NY and requires up to 10% travel

217

Quality Systems Coordinator Resume Examples & Samples

Design, Implement and Maintain Quality (ISO 9001) & Food Safety (FSSC 22000) Systems
Administrate the QMS and Food Safety Systems including Document Management & Control, Corrective Action, Internal Auditing
Lead HACCP Study Teams
Conduct HACCP Reviews
Conduct & track Quality & Food Safety systems gap analysis & communicate to site management team
Ensure all applicable Local Standards, Diageo Global Standards and Legislation requirements are incorporated into the Site Quality & Food Safety Management Systems
Ensure that all changes made to the Local & International standards are communicated to the site management & are implemented
Maintain Open Communication with the Diageo Global Quality/Governance Depts
Develop, advise & conduct training (Quality, Food safety, PRPS, GMP, GHP) with Internal Depts., Suppliers, Service Providers and others
Develop & Maintain site internal Audit Schedule (SHEQ/LTO) & communicate to site management
Conduct Internal /LTO Audits (Level 1) as per schedule
Capture & manage Audit (SHEQ/LTO) (Internal & external)results and Action Plans
Manage Corrective Action ,LTO Action Plans & LTO audit close out meetings
Co-ordinate Annual Management Reviews reflecting on the continuing suitability, adequacy and effectiveness of the ISO 9001:2000, SANS 10330: 2007 and SHE Systems, Policies & Objectives
Support the achievement of the Quality Index Target/OPQR (ensure testing of all raw materials, OTIFNE)
Compile Monthly Quality KPI’s reports (LTO, Supplier Performance, Internal NCA’s, Systems)
Partner with the SHE Team to provide a holistic Risk Support System
Co-ordinate on site Projects/Innovations trials
Provide Technical expertise for projects & trials conducted on site
Manage & Control all Raw Material Requirements/Specifications
Conduct Calibration & Assessment of Quality Controller: Raw Materials
Maintain open communicate with Suppliers & Procurement Managers in respect of Specifications, Raw Material Non-Conformances, changes in requirements etc
Attend Supplier Performance Review Meeting
Compile & maintain Supplier Performance Monitoring System (Supplier Performance Report, NCA report , CAR report)
Maintain the QA system in the laboratory (SOP’s, WI, Sampling Plans, CAR’s, NCA’s)
Support the Root Cause Analysis process
Provide support to internal customers in respect of trouble shooting, system design, attendance at meetings
Support & Implement the Manufacturing Excellence (Lean Manufacturing/Continuous Improvement Programme) requirements
Tertiary Qualification, preferably in a technical field and a Lead Auditor/Assessor Certification
At least 2 years’ experience with FSSC 22000 implementation in a multi-discipline food manufacturing or Quality environment

218

Quality Systems Compliance Manager Resume Examples & Samples

Experience in managing others at various levels and coordinating cross-functional teams
Experience in Quality Assurance, CAPA, Change Control. Document Control. Training Systems, Compliant Handling, and Compliance/Regulatory Affairs in Medical Device or Pharmacueticals, required
Experience in interaction with FDA or other regulatory agencies
Strong knowledge of cGMPs and domestic regulatory requirements
Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, automation, validation, SPC, etc.)
Experience with ISO Standards in Medical Devices and process improvements. Preferred: 7 years of directly related experience in regulated industry for Medical Device, Pharmaceuticals or equivalent, to include 5 years of leading people

219

Director, Global Quality Systems Resume Examples & Samples

Relevant college or university degree required; advanced degree preferred
Bachelor of Science degree in a science or technical field
12 or greater years of experience in the pharmaceutical industry

220

Quality Systems Consultant Resume Examples & Samples

Serves as project team member on EtQ related projects and performs advanced configurations to EtQ using EtQ Designer, Python, EtQ script, SQL, JSP, and HTML scripting
EtQ projects include Training & Qualification, Specification Management, Change Management, Complaint Handling, Document Control, Corrective & Preventive Action (CAPA), and others
Also helps team members troubleshoot complex technical issues and improve existing processes and functionality
Experience and comfort in working in a global project environment with business and IT project team members
3 years of extensive experience in Clarity (Niku) or other Project/Financial Management reporting tools
Experience working in GMP environment

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