Quality Specialist Senior Resume Samples

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BB
B Balistreri
Bethany
Balistreri
53524 Marks Wells
Los Angeles
CA
+1 (555) 189 9587
53524 Marks Wells
Los Angeles
CA
Phone
p +1 (555) 189 9587
Experience Experience
New York, NY
Quality Assurance Senior Specialist
New York, NY
Simonis Inc
New York, NY
Quality Assurance Senior Specialist
  • 11) Providing Quality Leadership and oversight for risk management across the Site
  • Performs internal audits and keep management informed of identified findings
  • 6) Providing Quality oversight for Deviation Management Program
  • 5) Performing review and approval of automation changes
  • Provide quality assurance of our system
  • Process Change Management
  • 12) Performing internal audits
Philadelphia, PA
Quality Assurance Specialist Senior
Philadelphia, PA
Kautzer, Streich and Jacobs
Philadelphia, PA
Quality Assurance Specialist Senior
  • Assist Application Developers and technical support staff in identifying and resolving problems
  • Define and establish overall User Acceptance Testing (UAT) quality approach
  • Assist in designing and ensuring overall integrity of the automated testing strategy
  • Develop automated testing processes and approaches according to JPMC Chase, and Six Sigma/CMM standards
  • Execute and maintain UAT test cases and test scripts
  • Perform the tests in both the QA and contingency/backup environments
  • Assess readiness and deviation of product/project performance based upon test results and product specifications
present
Phoenix, AZ
Senior Audit & Quality Specialist
Phoenix, AZ
Leannon, Robel and Rogahn
present
Phoenix, AZ
Senior Audit & Quality Specialist
present
  • Key Measures of
  • Completing all aspects (i.e. planning, execution and reporting) of assigned integrated audits, in accordance with Business Improvement and Regulation audit processes
  • Promoting continual improvement throughout the business
  • Preparation of information and data for management review process
  • Regulatory background as it applies to general and vocational qualifications
  • Good attention to detail and accuracy when reporting of activities and analyses
  • To recommend and promote practical and cost effective actions for improving the effectiveness of business processes and to monitor and support to ensure the successful completion of action plans
Education Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
Washington State University
Bachelor’s Degree in Chemistry
Skills Skills
  • Typically 5+ years of experience and demonstrated success at the highest level of the functional area as well as demonstrated success in a quality role
  • Ability to improve processes
  • Knowledge of MS Office (Excel & Access)
  • Excellent written and verbal skills
  • Ability to complete audit work and analyze results
  • Problem solving & critical thinking skills
  • High level of technical skill in functional area
  • Organizational and follow up skills
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15 Quality Specialist Senior resume templates

1

Senior Lead Quality Specialist Resume Examples & Samples

  • In-depth knowledge of systems development processes and methodologies (e.g. SDLC, RAD, RUP) covering the entire system development lifecycle
  • In-depth knowledge and experience in implementation of software quality assurance and software process improvement
  • Knowledge of industry used Project Management tools such as Clarity or MS Project
  • Knowledge in the SEI CMMI process improvement framework and experience in conducting CMMI appraisals
  • Good command of spoken and written English
  • A self-starter with ability to work independently with a strong sense of ownership
  • Strong leadership ability, motivating IT employees
  • Experience in conducting project health checks and project quality reviews
  • Experience in mentoring or providing consultancy support to project management community
  • Proven experience in an IT leadership role
  • Proven experience of project management, project management tools and practices
  • Typical qualifications would include an undergraduate degree
2

Senior Audit & Quality Specialist Resume Examples & Samples

  • Key Measures of
  • Promoting continual improvement throughout the business
  • Training and supervision of other members of staff as required in relation to the audit functions
  • Review and maintenance of department procedures and documentation relating to audit, as required
  • Provision of appropriate management information to the Audit and Quality Manager as required
  • Preparation of information and data for management review process
  • Participate in, and lead when appropriate, cross-departmental monitoring, audit and other project activity
  • The Senior Auditor and Quality Specialist will also support the broader work of Business Improvement and Regulation by working across the various functions of the division, including investigations into cases of appeal, malpractice, maladministration and breaches of security, regulatory monitoring, business continuity and data protection, when required to do so Experience, Skills and Qualifications Previous Work Experience
  • Assisting the Audit and Quality Manager on the planning and scheduling of audit activity as part of an integrated audit programme covering Pearson UK sites and Pearson suppliers as required by senior management
  • The Senior Auditor and Quality Specialist will also support the broader work of Business Improvement and Regulation by working across the various functions of the division, including investigations into cases of appeal, malpractice, maladministration and breaches of security, regulatory monitoring, business continuity and data protection, when required to do so
3

Senior Plan Document Quality Specialist Resume Examples & Samples

  • Advanced knowledge of plan documents and investment products
  • Advanced knowledge of Transamerica products and administrative capabilities, and plan-related information
  • Superior problem solving skills to analyze case situation and formulate appropriate action plans
  • Strong verbal and written communication skills to respond to inquiries by clients and internal Transamerica representatives
  • 8+ years of pension or plan experience
  • Ability to independently handle more complex plan issue
4

Senior Audit & Quality Specialist Resume Examples & Samples

  • To deliver, either solo or in a team, high quality, commercially focussed audits and advisory reviews that fulfil business needs/requirements
  • To recommend and promote practical and cost effective actions for improving the effectiveness of business processes and to monitor and support to ensure the successful completion of action plans
  • Identify best practice and work alongside management to deliver and implement pragmatic, commercial action plans
  • Undertake the lead or support of specific projects as required by line management
  • Collate management information for Management Review as required by the Head of Audit and Quality, Audit and Quality Manager and/or other senior management within Business Improvement and Regulation
  • To perform supervisory responsibilities in accordance with good practice and the Pearson people manager policies
5

Senior External Manufacturing Quality Specialist Resume Examples & Samples

  • Bachelor's Degree in engineering or a related field
  • 6 years within a supplier quality organization
  • 4 years in the Medical Device or Pharmaceutical industry
  • Master's Degree in engineering
  • Demonstrated working experience and expertise in CAPA and non-conformance systems
  • Extensive experience regarding root cause analysis and statistical techniques
  • Familiar with 21 CFR Part 210, 211, 820, ISO 13485, and ISO 14971
6

Senior Audit & Quality Specialist Resume Examples & Samples

  • Ensure Pearson's compliance with internalprocedures, regulatory requirements and external business standards such asISO9001 (Quality Management), ISO27001 (Information Security) and ISO22301(Business Continuity)
  • To deliver, eithersolo or in a team, high quality, commercially focussed audits and advisoryreviews that fulfil business needs/requirements
  • To recommend andpromote practical and cost effective actions for improving the effectiveness ofbusiness processes and to monitor and support to ensure the successfulcompletion of action plans
  • To assist in thedevelopment and implementation of processes, policies and procedures as aresult of reviews of current business practices
  • Identify bestpractice and work alongside management to deliver and implement pragmatic,commercial action plans
  • To communicateeffectively, both verbally and in writing with internal and externalcolleagues, customers and senior managers
  • Undertake the leador support of specific projects as required by line management
  • Collate management informationfor Management Review as required by the Head of Audit and Quality and theAudit and Quality Manager or other senior management within BusinessImprovement and Regulation
  • To performsupervisory responsibilities in accordance with good practice and the Pearsonpeople manager policies
  • To liaise withexternal agencies, including Ofqual, SQA, EAB and JCQ, as required inconnection with the role
7

Quality Assurance, Senior Specialist Resume Examples & Samples

  • Maintain state of the art audit program
  • Bachelor’s degree in a scientific discipline or equivalent with 8+ years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA
  • Experience with electronic quality management systems is preferred
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement
  • Knowledge and hands-on experience in regulatory inspections, vendor audits, and vendor qualification is required
  • Occasional travel up to 10-20% of time
8

Senior Specialist of Quality Assurance Resume Examples & Samples

  • Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products
  • Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills
  • Laboratory Experience or assay development experience preferred Knowledge of Compendia preferred
  • Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry
  • Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer
9

Senior Lead Quality Specialist Resume Examples & Samples

  • Day to Day management of contractor labs for Potency Testing Schedule for Acthar Program
  • Acting as Program Manager for Potency testing activities – new methods, method improvements, Stability testing
  • Liaison between Science and Technology, GES and Corporate teams for matters concerning Acthar Potency testing
  • Subject Matter Expert on all Achtar Potency Testing
  • Building technical knowledge base for potency testing – understanding factors which influence test and building a problem solving program to assist in testing troubleshooting
  • Lead Analytical Method Transfer activities when required to other third party and internal lab testing
  • Lead testing life-cycle initiatives to bring method improvements forward
  • Making fact-based, scientifically sound, quality decisions regarding testing within the requirements of cGMPs and applicable regulatory/industry guidance documents
  • Ensuring that the Performance of the testing is concurrent with Standards and Regulations that are applicable to the specific testing types
  • Translate complex engineering, manufacturing, and quality technical data into understanding format for executive presentations, managerial feedback and lab feedback
  • Reviews and analyzes corrective action reports and purchase orders in an effort to reduce and eliminate defects
  • Monitors quality control activities and systems at supplier and subcontractor facilities
  • Audit third party manufacturers, due diligence and vendor selection process
  • May perform deviation investigations into quality issues
  • Will perform elements of Program Management and Troubleshooting as needed
  • 10-15 years related Pharmaceutical experience (both API & Drug Product)
  • 5+ years’ experience in a managerial role
10

Senior Technical Quality Specialist Resume Examples & Samples

  • Experience with SQL and relational database concepts
  • Experience with test automation tools and/or software
  • Experience in development concepts and architectures
  • Excellent written & verbal communication skills. Must possess excellent interpersonal and communication skills to interact with all levels of management, business partners and application developers
  • Business acumen
  • Strong interpersonal and client consultation skills
  • Self-motivated and results-oriented
  • Problem solving & troubleshooting capabilities
  • Project management knowledge
  • In-depth analytical skills
  • Superior organization abilities
  • Process & procedure oriented
  • Experience with creating project test strategies and test plans
  • Experience with Continuous Integration a plus
  • Must possess excellent interpersonal and communication skills to interact with all levels of management, business partners and application developers
  • Must possess strong time-management, analytical, problem-solving and presentation skills
  • Thorough understanding of Quality Assurance as it relates to system development
  • Ability to interact effectively with IT and business individuals/teams at all organizational levels
  • Ability to effectively communicate to management risks, issues, alternatives, and recommendations
11

Bioresearch Quality Assurance Senior Specialist Resume Examples & Samples

  • Training & Development
  • Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology
  • Knowledge of procedural and records management requirements in a regulated industry preferred
12

Senior Surface Quality Specialist Resume Examples & Samples

  • Master's Degree in Engineering Discipline from an accredited school
  • Experience and knowledge of aluminum rolling and finishing operations
  • 6 years of hands on experience maintaining and using SQM systems
  • Proven track record of utilizing SQM systems to reduce customer claims and internal scrap
  • Demonstrated effectiveness working on teams with evidence of leadership potential
  • Demonstrated ability to operate in an advisory and collaborative role with internal and external customers
13

Quality Assurance Specialist Senior Resume Examples & Samples

  • Define and establish overall User Acceptance Testing (UAT) quality approach
  • Identify and coordinate UAT activities with user acceptance testers
  • Translate business requirements into UAT test plans, test cases, and test scripts
  • Execute and maintain UAT test cases and test scripts
  • Track UAT test cases, test scripts, and results
  • Coordinate production release business validation
14

Senior R&D Quality Assurance Specialist Resume Examples & Samples

  • The QAE will implement and maintain the quality system
  • Generate quality processes such as procedures, protocols, and reports
  • Report on the performance of the quality system and provide improvements if needed
  • Determine and enforce through functional groups the quality and regulatory requirements in accordance with company needs, based on current regulations and industry accepted best practices
  • Manage and coordinate calibration systems
  • Develop and implement corrective/preventative action plans
  • Manage the supplier quality system
  • Manage and coordinate Instrument Qualification, Operational Qualification, Performance Qualification activities
  • Management representative for the company
  • Primary point of contact with all external parties on matters relating to the quality system and regulatory affairs
  • Develop and organize companywide quality improvement efforts
  • Promote awareness throughout the organization of current good manufacturing practices including how the quality of our products may impact patient health and safety
  • Directly and through staff will identify and implement improved techniques for the control of quality, reliability, and safety
  • Participate in product development (research and development activities) as part of a Project Team
  • Demonstrated mastery of the principles in 21 CFR Part 820, ISO 13485 and ISO 14971
  • Experience with FDA regulatory submissions and in-depth knowledge of quality management system requirements
  • Ability to successfully host audits from customers and regulatory agencies
  • Keep up to date with best practice in Quality
  • Ability to work autonomously with minimum supervision
  • Demonstrated problem-solving and decision-making skills
  • Ability to deliver and meet deadlines
  • Good communication skills, capable of communicating ideas to colleagues and customers
  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.)
15

Senior tea Quality Specialist Resume Examples & Samples

  • Manages tea and botanical quality by tasting and evaluating flavor profile of teas and botanicals at different stages of testing
  • Manages tea and botanical blend formulation activities to ensure consistent high quality blends while balancing cost considerations and meeting demand plan
  • Determines quality and appropriate usage
  • Develops and implements initiatives to allow for cost improvements, quality enhancements, and supply chain integrity
  • Communicates results and quality issues throughout approval process
  • Supports consistency in manufacturing by evaluating tea and botanical inventories at warehouses, blending facilities, and distribution centers
  • Coordinates test requests of new recipes, including creation and delivery of test request, disposition of test batches, development of flavor profile description, and updates of manufacturing specifications
  • Monitors tea blend flavor profiles throughout crop year cycles
  • Consults with manufacturing to determine dispositions for tea and botanical matters such as blending decisions
  • Manages tactical tea and botanical position for blending facilities and warehouses
  • Makes recommendations to quality manager and tea leadership for strategic recipe planning based on current/future qualities and inventories
  • Executes recipe changes for all tea blends
  • Executes new recipe and item setup for all new tea recipes and usages
  • Trains and develops tasting room personnel
  • Approves tea related content by reviewing written tea related materials. Coaches business units to support initiatives involving tea communication and education
  • Conducts tastings and trainings for senior management, the trade, consumers, and print and broadcast media
  • Implements procedures to support quality specifications. Analyzes supplier performance against metrics developed by Global Tea Quality
  • Assists in the development of appropriate tea training materials
  • Supports tastings and SSC activities as needed
  • Experience with tea and/or botanical tasting or using other sensory stimuli -5 years
  • Experience with inventory management and quantitative calculations - 3 years
  • Experience and knowledge of tea and botanical blending - 5 years
  • Education (ideal education level or degree): Bachelor’s Degree Preferred
  • Leadership and management skills
  • Budgeting and cost analysis skills
16

Senior NC / Capa Quality Specialist Resume Examples & Samples

  • Facilitate implementation of CAPA and NC systems
  • Mentor, coach,and guide users of the CAPA and NC systems,Including;problem definition,root causeInvestigation,CAPA action determination,CAPA effectiveness
  • Monitor quality of CAPA and NC records and work with owners to address issues
  • Contribute to the continuous improvement of the CAPA and NC systems based on use patterns and user feedback
  • Develop, Implement and manage CAPA review board
  • Develop and report quality metrics on CAPA and NC performance
  • Assist functional areas with systematic problem-solving methodologies when resolving quality issues
  • Bachelor of Science degree in an engineering discipline (Mechanical,Biomedlcs, materials,lndustrlal,etc) or related technical field (microbiology,chemistry, etc) is required
  • ASQ Certification preferred but not required (such as CQA, CQE,CMQ/QE)
  • Demonstrated working experience and expertise In CAPA and non-conformance systems
  • Excellent communication skills (verbal and written).ExperienceIn problem solving and root cause illnalysis
  • Ability to successfully Influence others within project teams regarding quality or compliance concerns
  • Minimum 10 years with CAPA and NC in the Medical Device or Pharmaceutical
  • Industryls required), including;root cause analysis and statistical techniques such as Cause and Effect Analysis,s Whys,Six Sigma processes
  • Ability to motivate and mentor users to increase proficiency with CAPA and NC management
17

Senior Proposal Quality Specialist Resume Examples & Samples

  • Masters’ Degree in international relations, development, journalism, business, or a related field and minimum of nine (9+) years’ experience working on USG-funded proposals/programs
  • Minimum six (6+) years of business development/proposal development targeting USAID and other donors
  • Excellent writing, editing and verbal communication skills
  • Demonstrated track record in writing winning donor-funded technical proposals, including USAID
  • Ability to interact effectively with senior staff, external clients and stakeholders, including a proven ability to build consensus and relationships and influence and motivate teams to achieve goals
  • Highly-detailed, strategic thinker with substantial capacity to thrive in deadline-driven, dynamic environments
  • Software Proficiency: Microsoft Office Applications (required); SharePoint and/or Salesforce (preferred)
  • Native fluency in English is required; fluency in Spanish or French is strongly preferred
  • Domestic and international travel is required
  • Must be eligible to work in the U.S. without sponsorship
18

Quality Assurance Specialist Senior Resume Examples & Samples

  • Associate's Degree and 3 years related experience
  • In-depth knowledge of automated testing tools (e.g., WinRunner), quality control, and quality assurance approaches
  • Software Test Engineer (CSTE) or Quality Analyst (CQA) certification
19

Quality Specialist Senior Resume Examples & Samples

  • Typically 5+ years of experience and demonstrated success at the highest level of the functional area as well as demonstrated success in a quality role for a minimum of 1 year
  • Ability to improve processes
  • Ability to complete audit work and analyze results
20

Quality Assurance Specialist Senior Resume Examples & Samples

  • Leads the effort to work with software developers to resolves issues of incompliance through system modification, reconfiguration or workarounds. Establishes objectives for testing cycles. Develops test scenarios for unit, process, function, integration and acceptance testing
  • Leads the team in planning and estimating quality assurance support requirements for new products, new functions and new components. Leads audits and reviews
  • Oversees and leads the efforts to monitor adherence to quality standards in the development, implementation and upkeep of software products. Monitors effectiveness of the assurance process and tools
  • Oversees the tracking of quality assurance metrics such as defect density and open defect counts. Oversees team members responsible for testing and inspection of products to determine compliance with specifications
21

Quality Assurance Specialist Senior Resume Examples & Samples

  • Monitor core, management, and support processes within their assigned areas to assure implementation and effectiveness
  • Conduct Program Management Inspection (PMI) to assure compliance with the Statement of Work (SOW) and Company procedures
  • Conduct Equipment Condition Inspection (ECI) of aircraft and ground support equipment to assess the effectiveness of inspection and maintenance processes
  • Assess and report conformance and nonconformance
  • Conduct Personnel Evaluation (PE) to evaluate the knowledge, skill, and ability of personnel and assess the effectiveness of our technical training and certification program
  • Conduct Technical Inspection (TI) of work in progress and completed maintenance actions to assure compliance with Technical Data and evaluate the effectiveness of DI processes
  • Conduct Environmental Health & Safety (EHS) Inspection of work areas and activities to assure compliance with NASA and DI safety policies and procedures to include proper use of Personal Protective Equipment (PPE)
  • Provide oversight of support programs listed in the NASA AMOS Work Breakdown Structure (WBS)
  • Monitor documentation and records generated by all departments for compliance with NASA, FAA, and DI requirements
  • Ensure the proper and timely execution of FAA Form 337 for major repairs and alterations of FAA Type Certificated (TC) aircraft, engines, propellers, and appliances
  • Participate in Quality Management System (QMS) audits to assess conformance to standards and effectiveness of core, management, and support processes
  • Participate in vendor audits to assess their capability to deliver products and services to specifications and effectiveness of their QMS to assure quality and on-time delivery
  • Document and report daily monitoring and assessment activity including findings of conformance or nonconformance in QT9
  • Conduct validation audit to confirm implementation and continued effectiveness of corrective actions
  • Conduct training and examination of Designated Systems Inspectors (DSI) and DSI candidates
  • Provide technical supervision and oversight of DSIs performing production inspection activities
  • Conduct monitoring, surveillance, and recurring assessment of DSIs
  • Perform production inspection activities when qualified DSIs are unavailable or QA oversight is required
  • Conduct supply receiving – conformity/airworthiness inspection of repaired or manufactured items
  • Conduct investigation of nonconformance, malfunctions, defects, incidents, anomalies, etc
  • Establish and maintain QMS documentation and records
  • Create, review or approve (as authorized by Quality Manager) documentation such as EWO’s, TO TDR, OTR, and OTI
  • Assist all departments with data collection, troubleshooting and analysis
  • Participate in performance/process improvement activities
  • Provide training of other employees as well as assisting them in the performance of their job assignments through coaching, counseling, and guidance
  • Assist in development and validation of technical training
  • Perform other qualified duties as assigned
  • Knowledge of inspection and testing software systems
  • Ability to understand how test equipment can influence production
  • Ability to plan for and carry out long-term projects and develop forecast
  • Demonstrated attention to detail and quality throughout all production lines
  • Able to obtain and maintain a Secret security clearance
  • Five (5) or more years of hands-on experience in an aircraft maintenance quality assurance position
  • FAA-certificated Mechanic with Airframe and Power Plant ratings and current Inspection Authorization preferred
22

Senior External Manufacturing Quality Specialist Resume Examples & Samples

  • 6+ years of experience within a Supplier Quality organization; 4+ years of experience in the Medical Device or Pharmaceutical industry
  • Bachelor's and/or Master's Degree in an Engineering discipline (Mechanical, Biomedics, Industrial, etc) or related Technical field (Microbiology, Chemistry, etc.)
  • Experience in Electronic Quality System modules, such as ComplianceWire, CATSWeb, Documentum, QlickView, etc
  • ASQ certification (such as CQA, CQE, CMQ/QE)
23

Senior Mortgage Quality Assurance Specialist Resume Examples & Samples

  • Perform risk analysis, data integrity and make decisions regarding deficiencies identified during the review process. Review and analyze mortgage applications, credit reports, appraisal, income and asset documents to determine accuracy and completeness per guideline requirements
  • Provide training as needed to educate group/team the details of the Pre-Funding/Funding Audits provided by the Quality Assurance specialist. Communicate with appropriate individuals to ensure that deficiencies are cleared within required timeframes
  • Ensure that deficiencies captured during the review process are corrected and clearly documented providing a thorough audit trail
  • Participate in departmental projects as required
  • College education or comparable supplementary education with related work experience
  • At least five years of single-family mortgage related experience with a Bank or Mortgage Lending operation
  • Minimum four to five years quality control or single-family loan underwriting experience, both conventional and government loans
  • Loan compliance/audit experience preferable
  • Documents work performed; records deficiencies discovered throughout the course of the review and evaluates the quality of the files audited
  • Records evaluation in database for future compilation into a management report
  • Reviews responses setting forth any corrective action taken as a result of reported findings
  • Analytical thinking, problem solving, research and stress management skills
  • Exhibit a pleasant demeanor with clients and internal personnel via phone and email
  • Able to communicate with all levels of management, other departments and customers
  • Excellent math aptitude
  • Strong ability, desire and enjoyment in working with others, both employees and customers, in a firm, cooperative, courteous, professional and friendly spirit
  • Knowledge of computer applications, including Microsoft Windows, Word, Excel and Outlook. Ability to learn new software applications as required
  • A self-starter, dependable, accurate in completing responsibilities with strong attention to detail and organizational skills
  • Able to work within deadlines and under extreme pressure
  • Able to learn quickly, ask questions, take instruction constructively and be flexible in doing assorted tasks
  • Regular and punctual attendance required
24

Senior Business Quality Specialist Resume Examples & Samples

  • Reviews reports on current quality systems and supports improvements in order to enhance quality
  • Support Escalation process of Quality Compliance matters
  • Monitors trends, identifies issues, recommends and implements appropriate actions
  • Management of product complaints, timely reporting into local system, data trending
  • Handling Customer Complaints
  • 2 years+ experience in Quality Assurance within Pharmaceutical, Medical Devices or FMCG business
  • Knowledge of GMP and GDP preferred
  • It is preferred that the job holder is an experienced internal auditor or certifies lead auditor
  • English on upper-intermediate level as a must
  • Excellent interpersonal, collaboration, networking and communication skills
  • Readiness for business trips000019CQ
25

Senior R&D Quality Specialist Resume Examples & Samples

  • Reviews the operations involved in the compounding and filling of drug product to ensure compliance to established operating and manufacturing procedures
  • Verifies the performance of critical operations and activities
  • Reviews compounding documentation and dispositions bulk products for further processing
  • Investigates and resolves manufacturing and microbiological excursions
  • Reviews investigation records generated by PAM Microbiology Lab and interprets data for accuracy and completeness
  • Reviews and approves documentation and standard operating procedures relating to Microbiology, aseptic practices, and facility certification
26

Senior Customer Service Quality Specialist Resume Examples & Samples

  • Utilizes working knowledge of processing and quality functions, compliance with state and federal regulations, SOX, SEC, IMSA and quality functions in the Customer Contact Center
  • Verify and monitor the accuracy and completeness of information provided by others to ensure quality of service
  • Provides support for entry or intermediate level Customer Service Quality Specialists
  • Report and document deficiencies and/or inconsistencies in procedures, which affect quality or create potential problem situations. Work with management staff on resolutions. Actively recommend quality standards and process improvements as appropriate
  • Regularly audit the work within the teams for accuracy and adherence to procedures, provide one on one coaching or training recommendations to management on areas requiring improvement
  • Provide support to other teams as needed with resolving customer problems, processes, procedures, and customer satisfaction and resolution as primary objective
  • Attend and participate in various meetings with feedback and reports on quality assurance service levels, results, and recommendations for process improvements
  • Remain abreast of current procedures and changes
  • Participate in the development and implementation of a QA Reward and Recognition program
  • Review the work of others to ensure compliance with company policies, department policies SOX, federal and state regulations
  • Know all work types and business units
  • Identify improvement process and assist with training of team members
27

Quality Assurance Senior Specialist Resume Examples & Samples

  • Facilitates adherence to established quality system and compliance with respective regulatory agencies
  • Performs internal audits and keep management informed of identified findings
  • Write and revise SOP’s as needed
  • Performs review and approval of protocols, reports, and SOP’s
  • Maintain oversight of established training program with associated records
  • Identify potential quality system improvements to maximize quality and efficiency
  • Manage all assigned projects through to completion
  • Maintain continuous learning to keep abreast of regulatory or industry standards as relates to Quality Assurance requirements
  • Work independently and efficiently
  • Communicate effectively with client and co-workers
  • Ability to work independently and as part of a team, high integrity, self-motivation, adaptability, and a positive attitude
  • Bachelor's degree in Chemistry, Biology, Regulatory Affairs or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
  • 3 years relevant laboratory/quality assurance experience in a regulated lab environment, with preference for GLP or cGMP
28

Quality Assurance Senior Specialist Automation Resume Examples & Samples

  • Minimum of 3 years experience in cGMP regulated industry supporting computer systems and computer systems validation
  • Experience in one or more functional areas such as quality assurance, quality control, manufacturing or engineering
  • Experience with qualification of automation systems in a Pharmaceutical or Biotechnology environment is highly preferred
  • Computer systems development methodology is preferred
  • Technical writing experience in a cGMP environment
  • Prior supervisory/management experience is a plus
  • Strong leadership skills with the ability to effectively communicate with wide variety of customers
29

Senior Hardware Quality Specialist Resume Examples & Samples

  • 8+ years of general hardware quality inspection experience
  • Experience working in a manufacturing environment with accept and reject criteria for general quality workmanship
  • Experience working with assembly build processes, interpreting drawings and/or contractual flow down
  • Electro-mechanical manufacturing background
  • Experience presenting deliverable hardware assemblies to DCMA (Defense Contract Management Agency) for final hardware acceptance
  • Good organizational skills and ability to effectively coordinate multiple activities; self-motivated and ability to work with minimal supervision
  • Personal ownership and accountability, the ability to find solutions in difficult situations
  • Proven ability to work proactively with others, driving decisions while also functioning as a team
  • Ability to walk back and communicate concerns to operations and support team
  • ASQ certified Inspector
  • Associate’s Degree or related experience with certification
30

Senior R&D Quality Specialist Resume Examples & Samples

  • Maintains proper control of operations’ documentation by following SOP’s, manufacturing procedures, GMPs, ISO requirements, OSHA guidelines and other pertinent regulatory requirements
  • Format and edit controlled GMP/GLP, R&D and related documents and forms as requested through change control
  • Route documents for review and approval using the electronic docbase. Obsolesce and archive documents as required
  • Maintains both electronic and manual system files for change control documentation and current master records adhering to corporate and regulatory standards and regulations
  • Maintains database indices for the document change control system
  • Tracks the status of changes in the system
  • Maintains program for handling obsolete documentation and history files for archived records
  • Issues Master Records and other required documents for Pharmaceutical Science Operations
  • Conducts electronic database training for all new employees and assist Pharmaceutical Development (GMP) organization with the document processing related issues
  • Responsible for maintain indices & relevant records for documents sent offsite for archival
  • Supports the offsite archival process by coordinating with document owners and off-site vendor
  • Performs other assignments such as assistance with administrative support for assigned quality tasks and supporting Group Trainings, Annual training program, etc. as assigned by Manager
  • Thorough knowledge and experience with documentation systems and control techniques
  • Knowledge of computer databases, technical writing, and word processing principles, techniques and concepts necessary to maintain documentation change control system
  • Thorough knowledge of GMP concepts relating to a Pharmaceutical manufacturing environment and controlled documentation
  • Detail oriented with strong organization and coordination skills
  • Good analytical and communication skills, both written and oral
  • Good interpersonal skills with strong team player orientation
  • Ability to interpret and conceptualize manufacturing and analytical methods, processes and SOPs into a controlled system for traceability, retrieval, audit, review and approval
  • Strong computer skills, especially in a Windows operating environment
  • Training and experience equivalent to Bachelor’s degree in general science with an emphasis in administration, computer with four years of industry experience
  • Experience in the GMP quality, analytical laboratory or manufacturing functions is preferred
31

Senior Logistics Quality Specialist Resume Examples & Samples

  • Planning, coordinating and monitoring of re-/qualification and re-/validation activities of all CSL transportation systems and processes, including worldwide suppliers and customers
  • Creating and maintaining reports on the state of qualification within the Logistics Quality management systems
  • Directing and monitoring of internal and external staff in the preparation and execution of qualification documents, such as Qualification plans, protocols and reports
  • Maintenance/management of a valid qualification and validation status
  • Correct documentation of the qualification results
  • Review validation documents provided by transport system providers for adequacy in use for CSL products
  • Prepare Risk Assessments to support the introduction of new transport systems
  • Prepare Validation Statements to be used in regulatory submissions or on agency requests
  • 7+ years in GMP Quality, GMP Operations, or GMP Operations Support
  • Demonstrate extensive experience in Good Distribution Practices
  • Demonstrate extensive experience in Technical Writing and Good Communication Skills
  • Demonstrate extensive experience in Transport Validation or Equivalent
  • Demonstrate experience in negotiation skills, with clients and suppliers
  • Demonstrate experience in project implementation
  • Demonstrate personal skills required for team leadership
  • Experience in Logistics is an advantage
  • Qualified GMP Auditor is an advantage
32

Quality Assurance Senior Specialist Resume Examples & Samples

  • 1) Coordinating BPDR/FAR activities, including oversight of the BPDR meeting
  • 2) Coordinating Fact Finding, Recall Committee, and Market Action activities
  • 3) Performing and coordinating Product Quality Complaint/Adverse Event activities including PQC intake, handling sample returns, investigations, and compilation and analysis of PQC and AE data
  • 4) Working within the Change Control System to ensure requirements are met. Running IPT Advisory Council meetings
  • 5) Performing review and approval of automation changes
  • 6) Providing Quality oversight for Deviation Management Program
  • 7) Performing review and approval of deviations
  • 8) Authoring Annual Product Reviews (APRs)
  • 9) Authoring and managing Quality Agreements (QAs) concerning both other Merck Sites and external vendors and/or contractors involved in the GMP aspects of the Site
  • 10) Providing Quality oversight of supplier information across all categories of suppliers that service WP
  • 11) Providing Quality Leadership and oversight for risk management across the Site
  • 12) Performing internal audits
  • 13) Participating in regulatory inspections, including facilitating and RMT activities
  • 14) Presenting system overviews to regulators as needed
  • Lead and facilitate compliance projects to support sustaining and/or enhancing compliance
  • Lead and facilitate MPS projects to support enhanced efficiency and effectiveness
  • Support ad-hoc data requests and analysis
  • Author, review, and approve procedures and other control documents
  • Present/discuss GMP deliverables as the SME with Domestic and International Regulatory Agency inspectors and auditors
  • Assist with aspects of Regulatory Inspections and commitments
  • Participate in internal audits and shop floor inspections
  • Execute market actions, Regulatory Agency Communications (FARs, BPDRs)
  • Performing and coordinating Product Quality Complaint/Adverse Event activities
  • Process Change Management
  • CAPA Management
  • Automation Compliance
  • Performing gap analysis and remediation
  • Quality Support/ownership for applicable automation systems
  • Regulatory surveillance
  • Conduct training on compliance topics
  • Execute projects as required by the Associate Director
  • Minimum 5 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility
  • Strong analysis and critical thinking skills are required for this position
  • Ability to function effectively with ambiguity, changing priorities, and aggressive deadlines
  • Ability to make risk-based decisions
  • Excellent technical writing skills are required along with strong editing skills
  • Vendor collaboration/relationship, and influencing skills
  • Ability to drive results and influence others in the areas of data requirements, Regulatory/compliance issues, and timelines
  • Project management and facilitation skills required to drive projects to completion
  • Strong business process analysis skills for areas/processes for streamlining, and process re-engineering to enhance value proposition of function
  • Ability to work as part of a high performing team: good collaboration skills, high level of emotional intelligence, ability to maintain objective viewpoints
33

Brqc Quality Assurance Senior Specialist Resume Examples & Samples

  • Position Title: BioResearch Quality Assurance / Senior Specialist
  • Sector: Janssen
  • Location
  • Teaming & Collaboration
  • Prior pharmaceutical and quality/compliance related experience preferred
  • Sound problem solving and good negotiating skills
  • Quality mindset
34

Senior Crude Oil Quality Specialist Resume Examples & Samples

  • Maintain and continue to develop current Crude Oil Quality Oversight Program and data base. This data base includes the on-line and composite analytical data which needs to be evaluated for compliance with industry standards, regulatory requirements and relevant commercial terms
  • Review and evaluate the results of composite samples and on-line quality data to confirm products meet the specifications
  • Issue violation letters to shippers who deliver products that don’t meet Energy Transfer quality specifications published in most current Tariffs, Rules and Regulations
  • Work closely with shippers and 3rd party facilities to resolve issues with noncompliant shipments
  • Maintain expert level working knowledge and understanding of crude quality processes and industry practices
  • Monitor performance and accuracy of the laboratory and on-line testing equipment within the areas of responsibility, as associated with crude quality assurance sampling and testing
  • As required, be available to witness the equipment calibration and verification activities, such as lab testing equipment and on-line analyzers
  • Stay current with relevant API Standards/Recommended Practices and ASTM Test Methods
  • Under general supervision by the Quality Manager, work with control center, operations, and scheduling groups to resolve specification violations and/or perform Root Cause Analysis Investigations
  • Work with field operations to ensure that proper test methods are being followed
  • When requested by Management, participate in crude oil blending and optimization programs
  • Coordinate activities with other groups within Measurement and Quality Department
  • As required, audit the internal and 3rd party laboratories to ensure that testing equipment and practices continue to meet all commercial and regulatory requirements
  • As necessary, audit compliance of pipeline and terminal operations with the established quality procedures
  • Provide direction to contracted labs to ensure proper testing of oversight and/or assay samples; monitor lab performance and provide appropriate feedback to management
  • Inform and train relevant company personnel on quality testing, potential issues, initial response and determination of appropriate resolutions
  • Prepare quality budget recommendations for improvement of operations at the Pipeline and Terminal facilities
  • Consistently maintain and demonstrate a high regard for personal safety, for the safety of company assets, employees, and the general public
35

Senior Specialist GAH Quality Assurance Resume Examples & Samples

  • Provide end user training for Reliance
  • Grant user access for new users and edit permissions for existing users
  • Provide end user support as needed during Hypercare
  • Minimum of (5) years Business Analyst experience
  • Minimum of (1) year Reliance support experience
  • Experienced computer skills using MS Office (Outlook, Word, Excel, Power Point, etc.) and operation of other peripheral devices
  • Ability to understand end user issues, diagnose the root cause and resolve issues
  • Professional communication skills
  • Ability to manage multiple priorities in a fast paced environment