Senior Quality Specialist Resume Samples

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L Kshlerin

Lyda

Kshlerin

4623 Dejuan Hollow

Boston

+1 (555) 693 1110

4623 Dejuan Hollow

Boston

Phone

p +1 (555) 693 1110

Experience Experience

San Francisco, CA

Senior Quality Specialist

San Francisco, CA

Terry, Dooley and Little

San Francisco, CA

Senior Quality Specialist

Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks
Work intensively with Project Managers and Product Managers to understand the business
Provides quality systems direction, oversight, and guidance to drive global initiatives and develop/improve procedures
Work with management to improve quality system policies and procedures
Provide metric data for Management Meetings and measurement of site quality goals
Coordinates the facility’s food safety self-inspection program in support of the facility’s internal audit program. Provides on-going coaching and training for facility’s internal auditors. Responsible for reviewing all deficiencies, assisting in the development of corrective actions, trending of deficiencies, and tracking and reporting the completion status and verification of corrective actions
Independent development of GxP Policies, SOPs, and Supporting Documents throughout all of the Roche development related organizational enterprises (gRED, pRED, PD, GPS and affiliates) to ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety/pharmacovigilance which meet internal and external standards of regulatory compliance, as well as industry best practices and interpretations

Phoenix, AZ

A-senior Quality Specialist

Phoenix, AZ

Jacobs, Littel and Hammes

Phoenix, AZ

A-senior Quality Specialist

Develop and ensure maintenance of a consistent HACCP and SSOP format
Develop and ensure maintenance of a consistent pre-requisite program strategy and format
Allergen, Pathogen, and Foreign Material Control programs
Weight and Measures programs
Develop and approve training programs aimed at compliance to the following programs: HACCP, SSOP, NTIS, Water reuse programs, Weights and Measures, NR Investigation and answering
Schedule and lead training activities
Support each facility to maintain food safety systems and regulatory systems consistent with company continuous improvement processes

present

New York, NY

Customer Care Senior Quality Specialist

New York, NY

Christiansen Group

present

New York, NY

Customer Care Senior Quality Specialist

present

Provide continual communication associated with quality performance at the SCS level to respective Team Managers delivering coaching and development
Assists in planning and implementing department goals and makes recommendations to management to improve efficiency and effectiveness
Provides assistance, training and troubleshooting support to lower level staff
Observe participant contacts and evaluate Service Center Specialists (SCS) using established contacts standards and client specific expectations (two to four monitors and associated evaluations each month depending on contractual obligations)
Provide monthly reporting on team and individual observations to varying levels of call center and SBU management
Provides functional guidance, training and assistance to lower level staff
Raise awareness when performance standards fall below target levels, provide detailed analyses of the root causes and suggest options for corrective actions

Education Education

Bachelor’s Degree in Computer Science

Florida International University

Bachelor’s Degree in Computer Science

Skills Skills

Excellent team player with a strong ability to network and with drive for tangible results
Knowledge of quality systems, including statistical process control. ISO 9000 systems knowledge
Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
Capable of creating and delivering quality systems and training programs, serve as a site technical resource for quality program training and coaching
Good working knowledge of the SAP programming language ABAP
Strong background of SAP Quality processes, Testing, Automation (at-least one automation tool)
High commitment to quality, reliability and a self-motivating style of work
Basic knowledge in handling Unix/Linux environment
Able to prioritize, follow up and use data to manage quality systems and drive decisions
Willingness and ability to learn new subjects quickly

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Content Delivery Senior Quality Specialist With European Languages Resume Examples & Samples

Works proactively with the supervisor to propose improvements and innovations to content production processes, workflow and knowledge infrastructure to increase efficiencies in the delivery of content
Responsible for optimizing content structure and managing the posting / editing of content to knowledgebase and website updates in a complex, Microsoft SharePoint or Web-based content management system
Identifies problems and issues, troubleshoots and develops solutions, and manages customer interactions and expectations. Understands when exceptional circumstances require escalation of issues
Preferably skilled in using web-publishing and formatting tools and providing training / guidance to others in the use of these tools
Responsible for identifying leading practices in content presentation, developing guidelines and consistently applying these in practice to improve the consistency and usability of our knowledge infrastructure
Strong attention to detail a must
Ability to facilitate an effective group discussion / conduct technical training for junior team members
Good project coordination and time management skills, and ability to meet deadlines
Ability to work independently, adapt to changing priorities and work in a team environment
Experience of working with Microsoft Excel and Microsoft PowerPoint
Good understanding of content management principles
Ability to read and write English and Spanish/German/French/Russian is required
Bachelor’s degree or equivalent job experience is required

Customer Care Senior Quality Specialist Resume Examples & Samples

High School Diploma/GED required
Must be able to type at least 25 words per minute
The ability to work autonomously, with little direct managerial supervision
Organizational and time management skills with the ability to handle multiple tasks simultaneously
Proficient with Microsoft Office including Excel, Outlook, Access and Windows and Internet Explorer
Able to multi-task in a computerized system, responding to customer inquiries in a call center environment
Responds to telephone inquiries and complaints using standard scripts and procedures
Gathers information, researches/resolves inquiries and logs customer calls
Informs customers about services available and assesses customer needs
Provides functional guidance, training and assistance to lower level staff
Provides assistance, training and troubleshooting support to lower level staff
Schedules work to ensures accurate phone coverage monitors priority of calls and shifts escalated calls to assure resolution to problems
Assists in planning and implementing department goals and makes recommendations to management to improve efficiency and effectiveness
Observe participant contacts and evaluate Service Center Specialists (SCS) using established contacts standards and client specific expectations (two to four monitors and associated evaluations each month depending on contractual obligations)
Provide continual communication associated with quality performance at the SCS level to respective Team Managers delivering coaching and development
Notify respective Management and Trainers of any persistent problems associated with individual performance or procedures that require enhancement
Work with training department to communicate trend observations and develop correction strategies
Provide monthly reporting on team and individual observations to varying levels of call center and SBU management
Advanced knowledge of customer service principles
Exemplary levels of quality performance, defined through achievement and consistency
Prior benefits administration experience, (multiple disciplines, DC, DB, H&W,)
Must have at least a High School Diploma or GED, but 4-year college degree or equivalent work experience PREFERRED!
Prior Defined Benefits, Health & Welfare and/or other benefits administration experience preferred
Experience with quality monitoring programs and systems
English/Spanish 100% bi-lingual a plus

Senior Quality Specialist Resume Examples & Samples

Bachelor/master degree in e.g. business administration
Knowledge of and experience with the ISO 9001 and or ISO 14001 standard
Experience with the continuous improvement cycle
Knowledge of carlease
Manage multiple stakeholders within different disciplines
Manage change processes resulting in significant (customer) improvements

Senior Quality Specialist Resume Examples & Samples

Provide oversight for CMOs and product lines, including but not limited to: Change management
Investigations (process, complaint, and laboratory). Product release, Annual Product Review, Master documents (batch records, methods, labels, etc…)Validation protocols and reports, Stability data review / stability coordination Audit results and assisting audit teams as assigned, CAPA
Participate actively on cross-functional support and process improvement teams
Serve as leading technical expert in one or more key quality or compliance areas
Assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve process deviations and product failures
Create, approve, and implement quality system procedures associated with the product realization process as well as procedures associated with CMO management and oversight
Plan, execute and follow up on CMO site visits due to identified issues, validation/transfer activity or as routine periodic visits
Assemble information, develop the decision and rationale for material review board (MRB) and field alert report (FAR) decisions, including follow up investigation and summary documents for both FAR and MRB
Support CMOs with FDA and other regulatory body investigations and inquiries as needed
Support scorecard development, maintenance, reporting and action / project development from scorecards
Minimum 5 year's experience in a QA or equivalent role
Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
Sterile manufacturing and/or biotech experience an advantage
Preferred experience including, but not limited to the following: Application of cGMP to manufacturing and testing, Product release and investigations, Change Management and CAPA, Regulatory inspections / Regulatory Affairs, Validation, Statistical techniques

A-senior Quality Specialist Resume Examples & Samples

Develop and ensure maintenance of a consistent HACCP and SSOP format
Develop and ensure maintenance of a consistent pre-requisite program strategy and format
Allergen, Pathogen, and Foreign Material Control programs
Weight and Measures programs
Develop and approve training programs aimed at compliance to the following programs: HACCP, SSOP, NTIS, Water reuse programs, Weights and Measures, NR Investigation and answering
Schedule and lead training activities
Support each facility to maintain food safety systems and regulatory systems consistent with company continuous improvement processes
Utilize process metrics to anticipate potential problems and recognize existing problems that could affect product safety and quality. Identify root causes and resolve problems before they add risk and costs
Serve as liaison between plants and corporate staff on food safety and regulatory issues management
Advise Operations (corporate and plant), R&D, and Marketing on the development and maintenance of HACCP and SSOP plans to assure compliance to regulations and the production of safe products
Support plant management through regulatory audits, plant inspector challenges, and other food safety/economic regulatory issues
Review current control programs
Develop and ensure measures of compliance, with plant management staffs, to food safety and regulatory programs. Maintain open communication with OG and plant quality staffs regarding metrics of compliance to regulatory and food safety programs and activities
Support plants in answering and tracking NRs
Support plants with appeal determinations. Review NRs with plant management as necessary prior to registering appeals
Facilitate implementation of corrective action responses to address food safety & regulatory trends
Ensure and facilitate that annual HACCP & SSOP reassessments are conducted
Lead and/or support projects directed at, or associated with, initiatives dealing with food safety and regulatory issues
Lead maintenance activities to ensure Grants of Inspection at all USDA facilities are up-to-date and accurate
Minimum B.S. in Food Science or related field or equivalent years of experience and training
Minimum 5 years of food industrial experience in Quality Assurance
Excellent experience with government regulatory requirements in the processing of food
Excellent knowledge of food manufacturing processes and food safety
Excellent knowledge in using a full range of statistical and analytical tools and fundamentals
Excellent relationship and team building skills

Senior Quality Specialist Resume Examples & Samples

A Bachelor’s degree (or foreign equivalent degree) in a relevant discipline (Engineering , Quality Engineering, Life Sciences or a related field)
Obtained a relevant quality certification for the various and appropriate K-C product types (i.e. FDA regulated, Medical Devices, Cosmetics, PPE, Consumer Products, etc.)
Minimum 5-8 years of experience in a regulated business or facility where the candidate was in a leadership or senior technical role
Working knowledge and experience with relevant European Union Directives (e.g. Medical Device, Personal Protective Equipment, and Cosmetics etc.), Canadian requirements/standards, and other prominent (inter)national Quality requirements/standards
Significant experience with ISO 9001, 13485, 17025, 22716 and requirements and certifications and CE marking requirements

Senior Quality Specialist Product Resume Examples & Samples

Support Development and Renovation of new Product - Capsule - F&S Line for the businesses Nescafé Dolce Gusto, Special T and BabyNes
Support related factories as quality expert by developing standards, guidelines or Manufacturing instructions
Develop and maintain competences and quality awareness, and commitment to zero defect in the market or business vision
Assist other departments or external partners and provides them with services necessary to ensure quality by design in their field
University graduate or equivalent (preferred microbiology, chemistry or food sciences-related studies)
Demonstrated solid experience (8 years) in R&D and/or in Operations as QA manager in a factory, Production or Application Group Manager in factory or QA specialist
Knowledge in packaging material, statistics, HACCP, GMP, GHP, QMS, net weigh and powder, mixes, R&G, tea, soluble , Nestlé instructions
Experiences in different factories and/or market positions, environments (GMB, Centre, Region, Market, Expatriation, Mission, Special Projects)
Proven track record in delivering results by working with cross-functional teams
English mandatory and preferably French

Senior Quality Specialist / Expert Resume Examples & Samples

Develop, update and assess relevant analytical methods and instructions and for timely delivery of reliable data to Product Development Specialists, Manufacturing Specialists and PTC Konolfingen supported factories
Apply, build and maintain knowledge and expertise in food microbiology for shelf stable dairy products, including aseptics, heat treatment and sterility testing methods
Assure representation of PTC Konolfingen/Nestlé in fields of expertise
Develop the Science & Technology Strategy of the Food Safety Microbiology Group (5G Roadmap “Release of liquid product”), include partnerships with universities and key suppliers
Initiate, manage and drive knowledge building projects (in field of expertise) or business related activities
Organize and deliver technical support activities and provide training in field of competence (knowledge transfer)
Involve in networks and organizations outside Nestlé (e.g. IDF, IAFP)
Attend / lead scientific and industry committees in field of expertise
Ph.D. degree in a microbiological related area
More than 5-7 years of international experience in R&D / Operations with exposure to head office, different R&D centers/missions/major projects/markets
Experience in analytical microbiology and food safety microbiology
Experience in managing of research programs and projects
Good knowledge of Aseptic-UHT process and predictive microbiology is a plus
Fluent in English and basic knowledge of German

Senior Quality Specialist Resume Examples & Samples

Minimum of 6-8 years experience as a Quality Assurance Manager with a pharmaceutical company. Experience with clinical trial materials is preferred
Minimum of a BA degree in a pharmaceutical science, Biology, Chemistry or other college degree
Must have excellent analytical, problem solving, math, root cause analysis, computer and communication skills
Must have good organizational skills and the ability to conduct and/or, write and present investigations, SOPs, reports, quality metrics and business correspondence
Familiarity with Trackwise and document control is a plus
Must be able to address conflict professionally
Must be able to work well independently and in a group
Must be able to travel up to 50% domestically and internationally

Senior Quality Specialist Resume Examples & Samples

Initiate investigations for issues generated by nonconformities, customer complaints, SCARs, and Audit findings
Perform the risk assessments and evaluate product impact
Analyze and organize data from multiple sources by utilizing statistical and data analysis tools to identify trends and recommend updates or changes when necessary
Conduct Nonconformance and CAPA investigations to understand issues and identify root causes using quality knowledge and data analysis tools
Review and approve investigating plan and corrective and preventative action plans
Assist root cause investigation with appropriate tools
Write CAPA documents and reports
Write and revise SOPs as needed
Conduct training for CAPA process
Lead CAPA investigation activities and coordinate CAPA board review meetings
Minimum BS, 7+ years experience or MS, 5+ years experience in Chemistry, Biochemistry, and Biology related field, preferably with quality/technical operation experience in IVD industry
Understand Regulation Requirement for IVD products
Understand Clinical Chemistry products, production process and documentation requirements
Experience investigating nonconforming events using basic statistical and data analysis skills
Experience participating on and leading cross-functional teams
Thorough understanding of 21CFR 820 and ISO 13485 regulations for medical devices
Excellent writing and verbal communication skills
Experience in risk assessment/management

Senior Quality Specialist Resume Examples & Samples

Manage the Corrective and Preventive Action (CAPA) system
Manage the Nonconformance system
Manage the Customer Complaint system
Drive CAPA, Nonconformance, and Complaint investigations, including root cause analysis, corrective/preventive action implementation, and effectiveness checks
Drive and/or verify robust root cause analysis execution
Perform trending analysis (Quality Metrics) on a routine basis, including using statistical process control methods
Work with management to improve quality system policies and procedures
Act as the back-up for the QA Manager
Partner with QA Manager to perform training on internal and external Quality related topics
Support internal audits
Attend and participate in team meetings, and interact in a positive, professional manner
The position involves close interaction with cross-functional teams on technical issues and with the operations of the Quality Management System
Able to coordinate communication methods (meetings, emails, presentations, documentation) in order to drive the timely closure of issues
Develop and/or maintain quality metrics

Senior Quality Specialist Resume Examples & Samples

Executes internal quality system audits, and may include travel to other sites as needed
Clearly communicates audit findings and risks; and ensures corrections and CAPAs are appropriate to risk level
Assists in detecting trending, and analyzing global audit data; and reports on analysis, makes recommendations, and drives programs to improve products and processes
Carries out quality system due diligence and integration activities as required by the business
Provides quality systems direction, oversight, and guidance to drive global initiatives and develop/improve procedures
Advises and consults on project/quality plans, risk assessments and remediation plans
Identifies, designs, and delivers training programs to drive a quality culture
Supports internal and third-party [FDA, Notified Body, Customer] quality system audit activities (schedule, plan, perform, CAPA follow up)

Senior Quality Specialist Resume Examples & Samples

Take responsibility for professional quality and process management, minimize quality risks
Responsibility for internal / external audits
Make suggestions for continuous improvement, manage quality monitoring
Perform and support processes, supplier audits
Manage/coordinate task forces to analyze quality problems with products purchased by customers
Partial responsibility for OHS

Senior Quality Specialist Resume Examples & Samples

Demonstrates high level of proficiency in applying established tools and methods (for example, Six Sigma,Lean) to identify and realize new product or process introductions, as well as process and business improvements
Strong communication (written and verbal), facilitation, decision making, collaboration and conflict management skills required
Ability to collaborate effectively with all levels of management and influence decision-making across a matrix organization is required
The ability to think analytically and strategically to understand complex or ambiguous problems or issues is required. Strong statistical, analytical and financial acumen
Excellent listening, analytical, facilitation skills are required

Senior Quality Specialist Resume Examples & Samples

Work on Ariba >>> ERP Integration by applying functional expertise
Guide & mentor the junior members in the team on features / functionalities
Be part of continuous improvement in test methodology & strategy
Constantly challenge self to find unique and “hard to find” bugs to improve product quality
Document, research, and communicate defects discovered during test execution
Work closely with development team members to analyze and resolve defects identified by the test team
8-10 years strong functional experience in SAP MM & FI Modules
Strong knowledge of SAP modules SPRO configurations / settings
Good working knowledge of the SAP programming language ABAP
Good knowledge of integration techniques provided by the SAP like the RFC SDK, ALE/IDOC, BDC and BAPI Business Objects library is essential
Strong understanding of QA Processes; Practices & Methodologies is the basic requirement
Good working knowledge of middleware like SAP PI or Oracle Fusion is definite plus
Familiar with any Database concepts
Must be a quick learner with strong analytical & problem solving skills
Strong team player & ability to work under pressure

Senior Quality Specialist Resume Examples & Samples

Develops, modifies, executes and reviews software test plans and test cases. Analyzes and writes test standards and procedures
4+ years of experience in software testing, development, engineering, or related field
Experience in designing and running functionality, security, scalability and performance tests on web applications and backend systems
Experience with QA processes and tools, test management systems, QA automation, analyzing bug trends, java, SQL and related topics Preference for experience in ASP environments and agile development methodologies
Knowledge of java, HTTP, SSL, HTML, XML, CSS, or Javascript a plus
Familiarity with Opensource tools - TestNG, Jmeter, JIRA, and ANT is a plus

Senior Quality Specialist Resume Examples & Samples

Good Understanding of EWM Process Flow
Ability to configure EWM scenarios and Base Customizing
Functional Expertise in EWM scenarios mainly in Pre-Configured Warehouse, Inbound/Outbound scenarios, Transit Warehouse
Goal-oriented team worker with good communication skills
Ability to work independently, and eagerness to learn and explore new topics
Responsible for planning and executing SAP Implementation/Support activities regard to SAP EWM, EWM with transportation planning and ability to handle materials management
Validation of SAP EWM Module to ensure the quality
Add customer perspective before shipment by incorporating customer use cases
Providing validation deliverables on time and with quality
Ability to develop and maintain positive working relationship with stakeholders
Support Development and QM teams with appropriate feedback about the solution
3 to 5 years of work experience in SAP EWM
Good to have knowledge on Initial set up of EWM system and integration with ECC
Knowledge in Integration of SAP EWM with Transportation Management is an added advantage

Senior Quality Specialist Resume Examples & Samples

Understand the business needs & strategize the kind of testing required for the product
Understanding of the product
Lead team of Functional QA Engineers to develop use cases & run regressions
Test execution on multiple environments
Develops, modifies, executes and reviews software strategy, plans and test cases
Review the functional test cases written by the test engineers to make sure there is adequate test coverage. Mentor and guide them to consistently achieve the test coverage
Work intensively with Project Managers and Product Managers to understand the business
Work with Software Engineers, coordinating testing efforts within a highly iterative Agile-type development environment
Continuous engagement with customers, CustomerSupport/ProductSupport, Triage team to understand the challenges & provide solutions
Should be able to highlight risks & connect with stake holders to resolve
Responsible for reporting the testing status and managing expectations to the project stakeholders
Able to multitask and work on multiple projects simultaneously
Maintain professional relationships with various groups outside of QA including development, product management, customer support, and professional services
Should be flexible to work over holidays/weekends during critical situations
Work closely with Development Team to align the testing effort effectively
Represent QA effectively in Scrum meetings
Work closely with the Lab management teams for rapid turnaround of product deployment challenges
7+ years of QA experience testing applications based on Java, J2EE and web technologies
Bachelor’s degree in Computer Science Engineering or Equivalent
Experience working within an Agile/Scrum or similar development environment
Good knowledge on how API works and how they can be leveraging in testing
Experience with QA processes and tools, test management systems, QA automation, analyzing bug trends, SQL and related topics
Should have been in the role of a lead and leading the QA efforts for the team/product for a minimum of 3+ years
A clear understanding of the product development cycle, technical requirements and project management
Should have Automation experience with Open source tools such as Selenium, TestNG and JUNIT
Good in an object oriented programming language (preferably Java)
Proficient in commercial and open source testing tools (preferably Selenium RC or Webdriver)
Experience in designing and running stress, load, scalability and performance tests on web applications and backend systems a plus
Knowledge of HTTP, SSL, HTML, XML, CSS, or JavaScript a plus
Bachelor's degree and/or Master’s Degree in Computer Science or related field
Graduating with good academic record from top universities
Ability to understand and master new technologies quickly
Proven ability to quickly understand and solve unique and undocumented programming problems
Excellent written and oral communications
Energetic and self-starting

Senior Quality Specialist Resume Examples & Samples

Define and deliver the quality goals, quality strategy and standards
Align with related programs like e.g. S/4HANA or with DLM
Coach and support the teams of the respective delivery program to produce usable software each takt and reach defined cloud or on-premise qualities
Provide a transparent status to the stakeholders and proactively take appropriate actions
Act as ONE team to deliver the respective solution in a customer-centric approach
Have a good network into related organizational units such as Production / Solution Validation and other organizations
Excellent understanding of I2M, SAP’s quality standards and processes and its execution including design-led development process
Several years of experience in quality roles at SAP
Goal- and solution-driven with very good problem solving skills
Good team-player, drives for one SAP
Excellent German and English skills, both verbal and written
Knowledge and experience in test automation tools
Experience in cloud environment and/or application area is a plus
Knowledge regarding software logistics is a plus

Senior Quality Specialist Resume Examples & Samples

Independently reviews and approves product quality documentation such as master batch records and test methods related to external and/or internal manufacturing and testing of commercial product
Provides input for change control assessments and/or completes change control activities
Independently reviews executed batch documentation from external manufacturing and testing
M.S (or equivalent degree) and 0-3 years of relevant work experience, or
B.S in scientific or allied health field (or equivalent degree) and 5-8 years of relevant work Experience with API and drug product (oral solid dosage forms) development with knowledge of the following in a pharmaceutical setting
Experience developing/revising SOP’s and leading CAPA’s
Ability to thrive in a high throughput environment
Knowledge in the following areas

Senior Quality Specialist Resume Examples & Samples

Partners with clinical quality service lines to identify issues within operations for focus improvement efforts. Supports workgroups or committees (e.g. peer review)
Prepares meeting materials including agendas and minutes; coordinates conference room logistics; monitors and follows up with action plans)
In collaboration with the clinical lead, coordinates on-going, multiple projects (e.g. supporting the clinical service line model). Develops timelines and agenda items
Helps identify best methods and processes for performance improvement including developing project plans, facilitating group process, and training related to data collection/reporting
Supports groups through the full rapid improvement cycle. Helps identify and recommend actions to correct activities and processes
Analyzes, interprets information, and makes recommendations on data collection. Presents data in a graphical format to support leadership groups and committees' strategic planning and decision-making. Analyzes and compiles data into spreadsheets and databases. Helps identify and communicate alternative solutions to projects as needed
Abstracts data using Health Connect; runs reports and communicates results of analysis effectively to key stakeholders
Maintains and coordinates audits. Assists with developing audit methods to assess performance improvement and to ensure regulatory compliance. Based on audit results, creates and presents reports using various systems and databases (e.g. MIDAS focus studies)
Minimum three (3) years of experience in managing databases

Senior Quality Specialist Resume Examples & Samples

Supports establishment of GxP Standards; Policies & SOP throughout all of the Roche development related organizational enterprises (gRED, pRED, PD, GPS and affiliates) to ensure a consistent documents landscape for standards and processes related to clinical development and safety/pharmacovigilance which meet internal and external standards versus regulatory and compliance related regulations and interpretations
Builds and maintains strong relationships with key business stakeholders and ensures that PDQ is providing an efficient, effective and compliant process landscape to the functions
In close collaboration with supported functional areas and key business stakeholders, identifies needs for process standardization, regulatory compliance direction and areas for improvement
Ensures that business partner expectations for SOP strategy, materials and deployment are met
Collaborates with a network of subject matter experts (SMEs) within the functional areas supporting policy and SOP development
Contributes to the PDQ Standards & Processes Team to set strategies and achieve the long-term goals & objectives for PDQ QS and PDQ as a whole
Is knowledgeable of all services and activities provided by PDQ QS, Standards & Processes in order to provide business stakeholders with a comprehensive overview and effectively communicates how their training needs can be met

Senior.quality Specialist Resume Examples & Samples

Lead and coordinates key site initiatives (e.g. Make to Win, JJPS)
Initiative Deployment, Supports the Site Q&C in all tactical & strategic matters (governance), coordinate in Instantis
Supports deployment of change management programs for the site
Process capability analysis & Improvement support, by develops production & process control systems using appropriate techniques and tools (for example, advanced process monitoring and control tools, methods of statistical process control, process performance metrics)
Tracking for Quality project (Innovation Lab, Reliability Room)
Responsible for and manages the regional Cost Improvement Program and portfolio
Support the roll out and implementation of the JJPS (Johnson & Johnson Production System)
Supports deployment of change management programs
Leads the development of new detection systems, by developing optimal strategies and plans for conducting equipment, process, and product qualifications/validations
Develops process Quality control plans that are in accordance with product utilization and risk level
· Identify, recommend and implement continuous improvement opportunities as it relates to project execution for the region

Senior Quality Specialist Investigations Resume Examples & Samples

Oversee and maintain the site’s internal audit program by maintaining the internal audit schedule and performing internal audits
Evaluate the need for Corrective and Preventive Action(s) (CAPAs) and supervise and maintain the site’s CAPA program
Lead and/or performs manufacturing and complaint investigation activities to ensure compliance with procedural and regulatory requirements by facilitating investigation activities, providing analysis of data related to manufacturing and complaint investigations, and organizing and leading cross functional investigations as required
Identify and implement system improvements (CAPAs) and evaluate effectiveness of CAPAs
Oversee and maintain the performance of Annual Product Reviews (APRs) associated with manufacturing, packaging and release by performing APRs and completing data analysis and evaluation
Provide investigation, CAPA, complaint and audit information required for APRs, Management Review, Site Metrics and other business needs and assist with KPI metrics reporting and evaluation
Assist in preparation of documentation prior to and during Health Authority and Vendor Audits
Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience of direct cGMP compliance experience is required. A Master of Science Degree and 3-5 years of direct cGMP compliance experience is highly preferred. However, a combination of experience and/or education will be taken into consideration
Must possess knowledge of 21 CFR 210 and 21 CFR 211 as they relate to pharmaceutical manufacturing Quality Assurance and Regulatory. Must possess an in depth understanding of data and statistical analysis. Must possess an in depth understanding of grammar and punctuation. Must be familiar with TrackWise as it relates to investigations and CAPAs
Must possess skills in organization and prioritization; must be detail oriented and have the ability to perform multiple projects/tasks simultaneously; must be a self-motivator and independently find way to increase departmental efficiency. Must possess strong verbal, leadership and communication skills, and well–developed ability to constructively work across functional areas to achieve results. Ability to multi-task a large number of projects and evaluate priorities with minimal supervision. Must possess strong technical writing ability. Must be able to review, interpret, and discuss complex governing regulations, precedent interpretations, and current application. Must be adept at independent decision-making. Must possess a professional and cooperative attitude as a team player with all departments. Must project a professional company image while interacting with management of various subsidiaries and outside vendors. Must possess excellent proofreading skills; must be proficient in MS Office – Word, PowerPoint, and Excel
Must be proficient in spoken and written English. Ability to read and interpret complex business and/or technical documents. Ability to work with groups of people such as other departments, managers, and directors and communicate ambiguous concepts. Ability to present to a group of departments

Senior Quality Specialist, Document Control Resume Examples & Samples

Leads initiatives for Document Control process improvements and cross-functional implementation
Provides advanced guidance and mentorship for junior level staff
Identifies opportunities for development and implementation of Document Control processes
Performs analysis of issues/ data and provides feedback
Supports coordination of Document Control activities for audits and/or regulatmy inspections
Serves as the document control lead on internal cross functional project driven sub-teams
M.S. (or equivalent degree) and 0-3 years of relevant work experience, or
B.S. in a scientific or allied health field (or equivalent degree) and 5-8 years of relevant work experience, or relevant comparable background

Senior Quality Specialist Resume Examples & Samples

7+ years of QA experience testing applications based on UI5, PHP, Java, J2EE and web technologies
Experience in cloud development testing and release management
Good experience in Database and SQL
Must have Automation experience with Open source tools such as Selenium, TestNG and JUNIT

Senior Quality Specialist S Korea Resume Examples & Samples

Manage that the Shire Local Operating Company (LOC) and/or its vendor are compliant with local Good Distribution/Supply Practices (GDP/GSP) and other requirements against local regulations on pharmaceutical affairs, within the given scope of projects/products
Have sound relationship/ communication with local authorities on relevant topics and support/coordinate External and Internal inspections in the territory
Manage the day to day operations of Product Quality including but not limited to: Product Release; handling of returns, damages and rejects, temperature excursions and transport and Distribution deviations
Ensure Shire establish and retain all applicable licenses and permits required to import and distribute Shire products in the territory and complete workflow requirements on a timely basis
Ensure the country specific QMS is compliant with the in-country regulations per licenses, and with Shire global QMS
Support the shipment documentation process and relevant internal & external communication with SCM, such as advance customs clearance, import permit, etc
Manage the HCP sample management process with SALES team and other sample storage/release process for QA/RA/CR requirements
Ensure customer complaints are dealt with effectively and timely ensuring appropriate closure, reporting, and documentation
Manage the product/package specific code and relevant legal requirements for distribution in the territory
Approve and support any subcontracted activities which may impact on GDP
Support QA oversight (supervision) of Shire Distributor partner, including managing QA audit, QTAs, product launches, critical change controls(if necessary), and qualification of new Distributor partners

Senior Quality Specialist Resume Examples & Samples

Define automation test objectives, strategies, processes, standards, and metrics
Track and analyze own test results, take corrective action, report automation summaries, and update statuses
Participate in Functional & Technical requirements discussions with Product Managers, Product Owners, Architects and User Experience teams

Senior Quality Specialist Resume Examples & Samples

Responsible for QA oversight, documentation review and product disposition. Ensures non-conforming product is identified and appropriately controlled, and conforming product is appropriately dispositioned for use. Reviews and provides guidance for various non-conforming situations and ensures documentation is complete and accurate
Reviews Quality System documentation, including Production Batch Records, Variances, and Quality Analysis Reports (QARs), and appropriately dispositions affected materials. Performs disposition of manufactured lots, assuring product quality and SAP/LIMS database integrity in compliance with Quality System regulations
Utilizes the SAP/ LIMS and business inventory systems to evaluate and analyze batch record discrepancies and issues
Manages workload to ensure manufacturing and product launch schedules are met. Provides QA input, where necessary, in support of meeting timelines for new products and projects
Represents Quality Assurance in PMO projects, lean events and participates in Internal audits, when necessary
Reviews/approves documentation changes in Work Flows, when assigned
Individual may have to arrange hours to work until 7pm

Senior Quality Specialist Resume Examples & Samples

Closely interacts and builds effective relationships with people across site to promote quality, consistency and compliance. Provides quality support to manufacturing and NPI projects. Demonstrates courage and willingness to determine appropriate action and make risk-based, sound and timely decisions. Ensures and maintains compliance with internal and external (ISO 9001, ISO 13485 etc) standards and regulatory requirements
Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is deternied and the appropriate actions are agreed and implemented. Manages corrective and preventive action processes ensuring the timely and accurate resolution of problems identified
Takes responsibility for the measuring and monitoring of performance against agreed KPI's. Collates and shares information/data and trending as appropriate through reports and follows up on improvement opportunities. Actively participates and/or drives EU/Global QMS improvements as required. Actively contributes to the success of the overall QA team and the site. Identifies, advise and implements training/coaching to meet defined Quality Systems requirements
Performs/takes part in internal audits and external audits as required according to site and global plans.Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate. Takes responsibility for ensuring timely completion and follow up through to closure
Participates in personal development to further enhance skills and knowledge relevant to the position. Supports and maintains Company's Safety, environmental and Waste Management programme
Degree in a scientific discipline or equivalent experience in a relevant discipline
Quality Assurance / Auditing experience in a chemical, pharma or manufacturing industry. Lead auditor status is preferred
Experience in the one or more of the following - training, validation, problem solving tools. Understanding of statistics based management & procedure is preferred
Coaching skills – in order to support and help to improve on site
Ability to perform duties with minimum supervision
Ability to work on a variety of assignments at one time
Ability to recognize deviation from requirements and standard practice and understanding associated risks is essential in role

Senior Quality Specialist Resume Examples & Samples

Review no-nconformance request, customer complaints
Conduct non-conformance investigations to understand issues and identify root causes
Assist root cause investigation
Ensure Quality documentation is in compliance with TFS SOPs and Regulation requirement
Write non-conformance documents and reports
Conduct training for Quality process
Lead non-conformance investigation activities and coordinate material board review meetings
Minimum BS, 7+ years experience or MS 5+ years experience in Chemistry, Biochemistry, and Biology related field, preferably with quality/technical operation experience in IVD industry

Senior Quality Specialist Based Resume Examples & Samples

Perform global assay quality control reviews, monitor regional and/or global trends, implement corrective actions when needed to establish or restore acceptable global performance
Evaluate regional laboratory investigations performed for proficiency testing failures looking at global impact and trends
Supervise the input of data into the Scientific Database and the test code system
Manage inter-lab and vendor orders/shipments to maintain global inventory stock levels for harmonized reagents, calibrators and quality control material
Interact with vendors/assay manufacturers regarding technical assay information required to maintain quality assay performance

Senior Quality Specialist Resume Examples & Samples

Other Job skills and duties: Must have advanced skills in Excel. Use Excel advanced skills to maintain assigned data, create new templates and audit workbooks, summarizing data using formulas, pivot table, graphs, etc
Convert documents to and from acrobat, create Power Point Presentations with embedded content and use MS Word
Maintain department audit calendar, schedule, prepare documents, attend and produce meeting minutes for quality assigned meetings
Act as technical support for meeting setup
Act as technical support for quality staff and others as assigned
Perform data entry tasks associated with quality department and performance improvement project
Generate report using Crystal, Midas, and other assigned databases. Provide clerical support as assigned

Senior Quality Specialist Resume Examples & Samples

Participate in production meetings on behalf of QA/QC in order to support delivery commitments
May be required to assist with creating/reviewing documentation packages per Customer Quality Plan
Act as team lead on quality review boards and/or supervisor of quality teams
Works closely with the Quality Assurance (QA) team and internal customers to maintain quality systems and industry standards
Creating and improving QMS documents and records, and developing local quality plans and quality programs based on QMS by analyzing local requirements, practices and customer expectations
Will assure that all products and processes meet the desired quality, safety, efficiency and reliability levels
Execute corrective action and preventive actions (CAPA) processes within the structured continuous process improvement
Supervising the generation and interpretation of advanced analytical data
May act as an internal or external lead auditor
Will supervise the creation and implementation of quality control plans and supplier development projects
Will have a Quality / Technical approval role in the Non Conformance Notification (NCN) process
Providing instruction and knowledge transfer to the quality community and act as a mentor to junior Quality Engineers
May participate in management reviews
Will co-write internal & external technical presentations and publications for specified technology and handle special projects as required
You may also supervise a team in the execution of the above activities
Conducting all your business activities in accordance with Baker Hughes Health, Safety and Environmental policies, Legal Compliance requirements and Company Core Values
High School Diploma or GED with 4+ years of customer quality plans experience
Previous direct customer/client interfacing experience
Facilitation and presentation skills
Ability to work and communicate well with others
In depth knowledge of industry standards
Previous experience in presenting detailed and technical information preferred
Skills in quality control and calibration, business process modelling, SAP and the ability to communicate in local language are preferred
Lean six sigma and root cause analysis knowledge
Quality Engineering background is a plus
Previous internal/external audit experience also a plus
Associates degree or Bachelor’s degree preferred
API Q1 Lead Auditor certification

Senior Quality Specialist Resume Examples & Samples

Lead / supervise all aspects of Quality excellence with emphasis on continuing to improve operating results and strengthening underlying processes
Regular Client interfacing for feedback and Quality updates
Preferably Senior Quality Assurance Specialist specializing in Customer Service and with strong background with a banking and finance account
At least 2 year(s) of working experience in the related field is required for this position

Senior Quality Specialist Resume Examples & Samples

Proficient in Test Automation Tools like QTP/ Selenium/ jUnit/ Meter and code coverage tools
Knowledge in Java/J2ee is preferable
Able to define quality- and test strategies for products respecting defined process- and product standards
Analyzes, defines, implements and executes quality and test related activities according this quality- and test strategy
Subject matter expert for teams in terms of quality assurance and test related processes, methods and tools
Has proficient product domain knowledge incl. relevant business processes & scenarios and a proficient understanding of customer needs
Relevant experience is required

Senior Quality Specialist Resume Examples & Samples

Manage and own the activities required by global quality management systems in Shire as well as country specific systems
Assure the validity and update in Pharmaceutical Licenses and Permits required to import and distribute Shire product in the territory
Fulfill the responsibilities as ‘Import Managers’ or other quality representative role as registered to local authority following requirements in local regulations
Provide Quality support to the given project(s) in LOC, for both the existing business and the new product launches. Act as key Quality interface with local Suppliers and Customers, and work collaboratively with Shire Quality, Supply Chain and other key stakeholders, locally and internationally to ensure a timely delivery of fully compliant products to the country
Report the update and intelligence new in the regulatory environment for overall quality and distribution matters in the territory to Shire organization and external accordingly
Be accountable for the given KPIs from Quality organization in the territory
Pharmacist, as bachelor degree or master degree in the university
At least 5 years in the Pharmaceutical/Biotech/Medical device industry, including at least 2 years in a QA/QC environment
Good knowledge of Pharmaceutical/Medical device quality management systems
Knowledge of GMP/GDP in end to end manufacturing and supply chain
Understands regulations/requirements for biz license, import/export, market transactions, and transportation
Experience in handling inspections from local regulatory authorities
Experience of working with suppliers and customers
Experience in communication with regional/global organization in the company

Senior Quality Specialist Resume Examples & Samples

To help develop and support the maintenance of all aspects of the Quality Management
System
Facilitate the management of internal non conformance driven by product failure,
Compliance gaps, internal audits or complaints
To own and lead the CAPA (Corrective Action Preventive Action) quality policy for the site
Which includes the facilitation of the process of root cause analysis and preventive actions
Investigations including the evaluation of the preventive action effectiveness
Own and lead the HACCP management and compliance for the site, supporting the creation
And maintenance of HACCP documentation
To provide training, coaching and support for problem solving techniques and tools, GMP,
HACCP etc
Support the site to fully embed best sanitation practices and compliance to the Mondelez
Sanitation Quality Policy
Leads the development of new quality documents and maintenance of the documented
Quality systems to assure compliance with corporate requirements and legal standards
Own and lead the Internal Audit Quality Policy ensuring fully compliance to the schedule, the
Provision of trained internal auditors, conduct trend analysis on internal audits and identify
Areas of continuous improvement
Train plant personnel in innovative ways to develop understanding and consistency of
Interpretation of quality policies across site
To lead risk assessments and write rationales where required
Responsible for assessing Mondelez Quality and Food Safety policies implementation and
Supporting 3rd party visits
Track and report KPI’s to management on a regular basis
Conduct trend analysis and identify opportunities for focus and improvement
Actively participate in the Lean 6 Sigma journey
Build strong linkages with members of the Corporate Quality to build effective programs on
Site that add value to processes and improve the brand perception of our products
Support the process to remove risks that may lead to consumer harm or dissatisfaction,
Regulatory adverse comment and/or damage to the Mondelez brand(s)
Ensure the immediate communication of any high quality risks to the site Quality and Food
Safety Manager and agree activities
Support the investigation and remedial actions for any event
Academic background in relevant area of food science or engineering e.g. Chemistry, Microbiology, Food Science, Nutrition, Food Technology or related field
Quality auditing skills, HACCP, Sanitation and hygienic design knowledge
Planning & Analysis - Ability to evaluate the state of Quality and Food Safety Systems and practices in the factory as measured against Legislative Requirements and MDLZ Standards and expectations to achieve objectives
Confident influencer
Ability to communicate requirements and action plans
High level of energy and drive for results
Systematic & structured
Drives high standards and expectations
A completer finisher
Tenacity & resilience
Sound knowledge of Quality and Product Safety methodologies including HACCP and Hygienic Design, across a wide product portfolio
Work experience in food or pharmaceutical industry (food technology, central corporate function, R&D, quality systems implementation, auditing, manufacturing, project management and supply chain
English language

Senior Quality Specialist Resume Examples & Samples

Ensure that processes needed for the quality management system are established, implemented and maintained
Report to top management on the performance of the quality management system and any need for improvement and ensuring the promotion of awareness of regulatory and customer requirements throughout the organization
Liaison with external parties on matters relating to the quality management system
Oversee and ensure the quality of all outbound products shipped to customers through inspection, audit, and assessment of the quality system. Communicate specific quality issues found during inspection with the Supervisor and appropriate personnel/department(s) responsible for the defected products and reprocess
Document quality issues and analyze trends; submit data to management on a weekly basis. Use data to create training programs to educate personnel on the quality management system
Train new hires on the quality management system
Create, follow-up, and close preventive and corrective action requirements
Review documentation, records, and all paperwork associated with the production and business operations of the company as directed by upper management
Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures including Worldwide Business Standards
Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments
Being an effective team member by interacting and collaborating with others effectively, including in teams, in the workplace, and in culturally or linguistically diverse contexts
Minimum of 2 years in an implant department with a total of 5 years of fixed crown and bridge or equivalent combination of education and experience
7 to 10 years of dental/production line experience
2 to 5 years supervisory/ management experience preferred
Strong communication skills required
Strong understanding of present and past dental materials
Capable of in-process inspection with magnification to 10x
CDT (Certified Dental Technician) preferred
Ability to effectively present information and respond to questions from managers and clients
Ability to follow directions and work well with others

Senior Quality Specialist Resume Examples & Samples

Work closely with scrum team (development, Product Management and scrum lead) to understanding feature requirement
Build innovative, scalable and maintainable automation systems to facilitate both functional and performance testing
Provide innovative and out-of-the box ideas to solve deep technical automation problems
Build tools to eliminate or reduce day today basis manual tasks/effort
Build/Enhance advanced automated test framework and suites to qualify our world-class applications
Analyze and decompose various integration points (Simulators) within/outside SAP Ariba’s Ecosystem and design a strategy and implement
Research new emerging tools and enhance existing automated test systems
Automate 100% of test cases. Most needs to automate using Junit and few on UI automation
Presenting ideas for system, automation infrastructure and process improvements
BE/MS in Computer Science or equivalent qualification
8+ years of relevant work experience, including development and/or test automation experience
Experience in building automation framework, simulators and automating complex feature’s
Excellent coding & Analytical skill in Java and must have experience in designing and writing JUnit tests
Must have experience testing complex features with customer aspect test scenarios for the feature life cycle
Must able to understand problems in software, isolate as need and file a defect with clear/detailed instruction
Experience in using any Bug Tracking, Test case management and Version Control Systems
Must have experience with at least one web based UI Automation tool (ex. Selenium/Protractor)
Work experience in sprint boot automation framework is added plus
Experience with at least one scripting language ex. Shell, Perl, Java Script etc
Knowledge on Database concepts and should have an exposure for PL/SQL
Basic knowledge in handling Unix/Linux environment
Demonstrated ability to take initiative and run new processes in an existing team
Follows good coding & automation standards
Excellent verbal, written communication skills and good team player
Leadership skills to work cross dependent teams and drive to closure of the item

Senior Quality Specialist for SAP Hana Database Resume Examples & Samples

Able to analyze, define, implement and execute quality and test related activities according to the quality and test strategy
Able to coach teams (Senior) in terms of quality assurance and test related processes, methods and tools
Work with a high degree of freedom and responsibility in respect to the design
University degree in computer science, engineering or related area
Years of experience in Quality Assurance (QA) and Control (QC) in software delivery process
Background in Bug tracking tool (Bugzilla, Jira,..) and system management tool like Jenskin, Messo .etc…
Distribution strategies for data

Senior Quality Specialist Resume Examples & Samples

Very good Bachelor’s or Master’s degree in (business) informatics, natural sciences, or economics or in a comparable field
Very good analytical and problem solving skills
Fluent in German and in English
Experience in the following areas is a plus
Cloud environment and/or application area
Continuous Delivery
Minimum 3 years of work experience in a quality role or similar experience

Senior Quality Specialist Resume Examples & Samples

Strong Programming skills is a must
Expertise in JAVA / J2EE stack
Strong test development and automation skills. Expertize in one or more of the following tools/frameworks are must
Junit/TestNG,
Selenium,
Experience of one or more of scripting and build automation tools(Ant, Perl, Shell, Python, Maven) is a plus
Demonstrated ability to analyze and solve problems as well as effectively communicate software defects
Experience working in cloud technologies is a big plus
7+ years of software engineering or related experience

Senior Quality Specialist Resume Examples & Samples

Challenging and supporting project manager in qualification and approval tests (APQP)
Coordinating approval of new suppliers and new parts in collaboration with procurement
Coordinating quality actions agreed with suppliers in projects
Facilitating and driving D-FMEA’s
Investigating and integrating previous lessons learned from customer claims

KYC Senior Quality Specialist Resume Examples & Samples

Conducting CDD / EDD on assigned new clients in all risk classes (Low -High Risk)
OFAC/World-Check screening
Ensuring information and documentation provided by Business Lines is correct and in good form
Maintain a working knowledge of AML and OFAC regulations and be able to relate them to SG policies and procedures
Apply the SGUS Know Your Customer Procedures to assigned accounts
Maintain good working relationship with the business lines
Familiarity with the principles of risk based KYC, client risk assessment and the products used in a wholesale banking and institutional broker dealer business
Microsoft Office, Word, Excel, PowerPoint
Four to Six years experience in the Financial Services industry in a KYC or AML capacity

Senior Quality Specialist for Out Of Home Beverage Machines Resume Examples & Samples

Ensure Right First Time by Design of new machines during all relevant Development phases through System Quality Performance to delight our Consumers
Ensure all tasks are properly accomplished and implemented during the R&D phases
Organize knowledge transfer and proper involvement of the team before the start of production of a new machine
Prepare and conduct proper Hand-over with Operational Quality team
Master Degree in Mechanical Engineering with a strong background in Quality
A background in Electrical appliance is a plus
Solid background on Quality, Safety, Good Manufacturing Practices, Manufacturing, R&D, In and Out Of Home appliances and Medical devices
Minimum 7 years of R&D or/and Operating/Manufacturing experience
Significant exposure in different projects and support activities of the organization (variety of assignments and missions)
Natural Leadership & Communication skills

Senior Quality Specialist Resume Examples & Samples

Drive activities within a cross-functional organization to ensure compliance of the company’s Quality Management System with ISO 13485:2016, ISO 9001:2015, and with regulatory and customer requirements
Design, evaluate, implement and maintain quality assurance programs and systems for product and/or process development, for manufacturing and for testing, all to ensure product quality
Review production processes and quality tests to ensure that they are being conducted according to approved protocols and set specifications
Bachelor or Master Degree
Knowledge of ISO 13485 and ISO 9001 Quality Management Systems
Experience in Medical Device or Pharmaceutical Industry is an advantage

Senior Quality Specialist Resume Examples & Samples

Good Communication, Reasoning and Analytical skills
High level of commitment towards ownership of product/topic will be the key for success. Strong customer focus required
Team player who is looking for new challenges
6+ years of relevant experience in Testing and Quality Engineering

QA Senior Quality Specialist A&I Resume Examples & Samples

You will have excellent communication skills and have demonstrable relationship building expertise with both suppliers and business partners
The ideal candidate will have a goal-oriented approach to project management coupled with the ability to manage simultaneous projects
Excellent organisational and administration skills are required in addition to strong interpersonal skills
Thorough knowledge and understanding of Regulatory requirements and filing processes is required
Operational Excellence qualifications are an advantage

Senior Quality Specialist Resume Examples & Samples

Develop and implement quality systems, provide coaching and guidance to Operations and R&D on system requirements and strategies to manage compliance
Create and sustain a collaborative work environment. Act as a liaison between Operations and R&D, working proactively to ensure the success of new product startups in the manufacturing environment. Interact with technical experts at suppliers or contract manufacturing sites to address customer complaints and resolve product quality issues
Develop and deliver quality systems training. Serve as a technical resource for quality issues and on continuous improvement projects, continuously developing technical knowledge and providing training to the organization on relevant learnings
Use prior experiences to help problem solve, search and apply solutions. Work with the organization to align on implementation plans. Champion quality across the organization to ensure delivery of defect free products to our customers and consumers
Develop internal quality self-assessment program and internal auditors. Train and lead cross-functional teams to perform internal audits, review/analyze data and documentation to assure compliance with quality and regulatory requirements. Lead development of corrective and preventive action plans and timing
Manage Quality Incident reporting and CAPA system to prioritize and ensure follow up on corrective and preventive action plans. Track data to identify trends and align internal teams on programs to eliminate the root cause of quality issues
Understand and manage quality/compliance risks. Make recommendations of action steps to deal with risks based on knowledge of relationship between functions and impact on quality and compliance issues to the business
Represent the quality team on continuous improvement projects. Coach teams to develop action plans for quality system improvements utilizing tools such as root cause analysis and why-why methodologies
BA/BS in a technical field
Five or more years of relevant experience implementing, managing and auditing quality systems
Experience with quality management tools and quality system requirements
Prior knowledge of the automotive aftermarket industry preferred but not required
Ability to understand, interpret and follow policies, practices and procedures and relay this information to cross functional teams
Able to represent the business independently when working externally with suppliers and contract manufacturers
Able to make decisions and operate with minimal supervision in a dynamic environment
Able to prioritize, follow up and use data to manage quality systems and drive decisions
Capable of creating and delivering quality systems and training programs, serve as a site technical resource for quality program training and coaching
Ability to understand and manage quality and/or compliance issues and make recommendations for action steps to deal with risks

Senior Quality Specialist Resume Examples & Samples

Preferrably has a Bachelor's Degree in any field
Ability to exercise flexibility to work effectively in a changing environment. Ability to adapt to changes in work environment, work assignments, and/or changes in priorities
Ability to pay close attention to detail with a high degree of accuracy.- Good written and verbal communication skills
Ability to perform routine, repetitive tasks accurately, with interruptions to meet deadlines
Good knowledge in Excel
Experience in creating reports, dashboards and templates preffered
Good analytical skills a plus
Plan and manage training/roll out/audit schedules across all accounts
Conduct audits across all accounts to ensure that all TQ Processes, COPC Standards etc are being followed

Senior Quality Specialist Resume Examples & Samples

Leads the plant’s efforts to maintain SQF certification. Maintains SQF Practitioner certification
Assists with implementing sanitation assurance initiatives, pest control and platform regulatory compliance programs
Maintains standards for cleaning equipment, developing cleaning equipment SOP’s and calibration programs. Performs verification and validation activities on the sanitation program
Leads and directs sanitation team to improve and sustain results in the Environmental Monitoring Programs (EMP and APC swabbing)
Coordinates key elements of the allergen control program including ingredient labeling, segregation, storage, cleanup process, verification of cleanups, and validation of cleanups, and on-going verification and validation of the entire allergen control program
Develops Quality and Food Safety training programs, provides training for production and administrative personnel as required, and ensures employee understanding of training through verification of activities
Provides direction and guidance to management during food safety and quality issues to ensure product is appropriately protected and root cause, corrective and preventative actions are identified and implemented
Monitors and provides monthly reporting on key food safety measures (HACCP, Food Safety and Prerequisite programs) and leads efforts to drive continuous improvement
Coordinates with Operations and Engineering management to evaluate new equipment and facility layout for sanitary design and works cross-functionally to implement necessary corrective action
Investigates food safety consumer/customer complaints, identifies appropriate corrective action and provides professionally acceptable written resolution as needed to the platform Food Safety & Quality group and Customers
Assists Quality Manager and/or leads as required during Regulatory audits, 3rd party Inspections, Corporate audits, and Customer visits
Coordinates the facility’s food safety self-inspection program in support of the facility’s internal audit program. Provides on-going coaching and training for facility’s internal auditors. Responsible for reviewing all deficiencies, assisting in the development of corrective actions, trending of deficiencies, and tracking and reporting the completion status and verification of corrective actions
Acts as liaison for all technical and QA issues between cross-functional departments
Supervises QA technicians across all shifts of production including oversight of plant product sensory program and raw material receiving
Address food safety related hold or scrap issues including initiating and closing quality incident reports
Serves as primary back-up in the absence of Plant Quality Manager
B.S. degree in Food Science, Chemistry, Biology, Business or related field
Minimum four to six years of experience in Quality Management in a food, beverage or dairy production environment preferred
Three or more years of experience supervising or managing quality in a food, beverage or dairy production environment preferred
Advanced knowledge of FDA, HACCP, and SQF
Food safety audit experience required. SQF (preferred), BRC or other
Infinity software experience is a plus
Experience of federal/state food safety regulations
Computer proficiency. Microsoft Office experience
Strong relationship building skills
Ability to read, analyze and interpret regulatory compliance guidelines
Ability to implement quality systems
Ability to interpret a variety of technical information in mathematical and/or narrative form and deal with several abstract and concrete variables

Senior Quality Specialist Resume Examples & Samples

Independent development of GxP Policies, SOPs, and Supporting Documents throughout all of the Roche development related organizational enterprises (gRED, pRED, PD, GPS and affiliates) to ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety/pharmacovigilance which meet internal and external standards of regulatory compliance, as well as industry best practices and interpretations
Establishes, maintains and fosters strong relationships with key business stakeholders and ensures that PDQ is providing an efficient, effective and compliant process landscape to the functions
In close collaboration with supported functional areas and key business stakeholders, proactively identifies needs for process standardization, regulatory compliance direction and areas for improvement
Ensures, in collaboration with business partners, that Policies and SOPs in the GxP process landscape are up-to- date and compliant with applicable current Clinical and safety/pharmacovigilance international regulations
Collaborates with a network of subject matter experts (SMEs) across the functional areas supporting policy, SOP and supporting document development
Contributes to the PDQ QS Standards, Systems and Processes Governance Team to set strategies and achieve the long-term goals and objectives of PDQ QS and PDQ as a whole
Is knowledgeable of all services and activities provided by PDQ QS, Standards, Systems and Processes Governance in order to provide business stakeholders with a comprehensive overview and effectively communicates this to stakeholders
Functions as trainer/mentor for technical skills for junior staff
Maintain in-depth knowledge of company policies, SOPs, and supporting documents related to pharmaceutical development and Quality Management. Maintain knowledge of FDA and EU regulations, ICH guidance documents, and other international regulations related pharmaceutical development relevant to GxP Policies and SOPs being developed

Senior Quality Specialist Resume Examples & Samples

Expert in preparing functional test cases to cover all possible scenarios, including scenarios that might not have been formally documented
Doing end to end manual testing and black for testing for functionalities that are newly developed
Designing and Developing Test Automation for functional testing, must have hands on experience with automation of cloud based solutions
Understanding and experience in building scalable and distributed cloud Applications using cutting edge Technologies (Cloud Foundry, DOM, OData Services)
Knowledge of lean development infrastructure process including Git/Gerrit, Maven 3.0, Maven Plug-ins & Mojos
Familiar with DevOps including Continuous Integration/ Continuous Delivery
Knowledge of Continuous Integration including Jenkins job configurations, build processes, REST API for automated job creation and scripting for build automation (Ant, Perl, Shell, Python, Maven) is a big plus
Trouble shoot functional and nonfunctional defects effectively, report and track defects
Lead end to end QA and testing activities with minimal input and directives from the management
Lead continuous improvement, incorporate all the lesson leant to ensure we don’t end up facing similar problems time and again
Propose, setup and maintain optimal QA landscapes to carry out various test activities during the lifecycle of the product
Propose, setup and maintain optimal Demo landscapes that would enable us to demo various product scenarios to prospective customers and during key events
Strong customer facing skills to co-ordinate and manage customer expectations during rollout and customer onboarding
Build strong rapport with each developer in the team and help them achieve the best quality
Good communication skills, team player, self-motivated and highly self-driven individual
Fulltime Degree in Computer Science/Engineering (BE/Btech/ME/Mtech/MCA Regular with 65% and above marks)
Must have lead QA activities of a product development, preferably cloud based
Sound hands on experience in design and development of Test Automation for new age cloud solutions
Fast learner with agility to swiftly adopt to priority changes and technology changes
Sound working and technical knowledge with HANA, UI5, Scripting, SQL, and Cloud technologies
7 - 9 years of experience and proven track record of software Testing/ Quality Assurance as a QA Lead

Senior Quality Specialist Resume Examples & Samples

Defining project testing strategy
Advising and coordinating the teams testing activities
Developing technical best practices and ensuring adherence to them
Ensuring appropriate use of automation and regression tests
Validating non-functional requirements
Coordinating testing activities with customers
Defining defect tracking processes & tools
Validating quality of releases
Coaching and mentoring other QA team members

Senior Quality Specialist Resume Examples & Samples

Performs GMP walkthrough inspections within IPT or E2E to ensure compliance with cGMPs and regulatory requirements
Supports risk processing of material within the IPT or E2E through collaboration with Operations, Technology, and Planning
Performs review and approval of Master Batch Records (MBRs), LIMS CRs, ACRs, etc
Supports the preparation of regulatory filings by providing data and review, as required
Maintains a broad-based knowledge of GMPs, Merck Manufacturing Policies, Guidelines and Procedures, regulatory guidance, evolving regulatory trends, and the working mechanics of MMD. Provides guidance to Operations and/or Laboratory Operations on quality issues based upon experienced and mature judgment and utilizes strong interpersonal skills to work with a diverse group of personnel in handling non-routine issues
Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc
Represents Quality on assigned project teams and leads those projects relevant to Quality within the IPT or E2E. Develops/updates systems on the aspects of material control/product release/shop floor compliance/deviation management within the established policies and guidelines. Supports company strategic, departmental operational excellence and manufacturing regulatory initiatives. Responsible for acting as the quality representative on capital projects
Leads/supports administrative activities in Quality including Profit Plan, Budget, etc
Actively participates in site inspection/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative for assigned IPT or E2E
Acts as a liaison with the Laboratory to prioritize the testing of samples to meet supply and schedule adherence needs and to work with the laboratory on optimization of cycle times
Provides training to incoming personnel and ensures compliance with departmental procedures
Minimum of 5 years experience in a Quality Control, Quality Assurance, Manufacturing environment or related field
Familiarity with vaccine/pharmaceutical processing is preferred
Skills: Effectiveness and creativity in approaching and solving technical problems. Proficiency in project planning and execution
Strong understanding of regulatory requirements and cGMPs
Superior verbal and writing skills
Demonstrated leadership competence

Senior Quality Specialist S Resume Examples & Samples

Define Test strategies for assigned Best Practice content areas such as dedicated S/4HANA cloud editions or test projects simulating customer implementation projects in the cloud. Work in close cooperation with tool and content development as well as Scenario owners
Define the operational test plan – systems, clients, tester resources, test scope, test approach
Conduct tester kick-off meetings
Coordinate and monitor test progress and ensure completion according to deadlines
Follow up on test results, address and resolve blockers and work towards a high quality delivery to meet defined KPIs according to deadlines
Provide reporting to central program management and Senior management team
Strong experience in quality engineering in SAP application or technology development with focus on ABAP based development projects. Alternatively work experience as a consultant focusing on test management in SAP implementation projects preferably in the area of Logistics or Financials
Experience in definition and setup of SAP test landscapes
Excellent communication skills in English and German are both mandatory, ability to interact with team members, project leads, developers and (Senior) management in a global work environment
Strong willingness and ability to learn
Hands on experience using standard SAP Basis transactions and SAP TMS
Configuration skills in SAP ERP Financials or Logistics and/or integration technologies

Senior Quality Specialist, E-systems Resume Examples & Samples

Will be a business administrator for Quality eDMS, eQMS, and LMS systems
Will support initial and routine upgrade system validation activities
Will act as an author and/or reviewer of applicable SOPs and Forms
Perform quality unit role on cross-functional system implementation teams
Excellent written and verbal communication skills; excellent public speaking/presentation skills and experience with creating training materials in PowerPoint or other presentation formats
Broad knowledge of Quality System implementation and maintenance
Demonstrated analysis and problem solving skills
Ability to lead in cross functional teams in identifying training requirements/solutions
Ability to work in a dynamic, fast paced environment with shifting priorities

Senior Quality Specialist / Quality Expert Resume Examples & Samples

You define and deliver the quality goals, strategy and standards considering our cloud development principles
You align with the quality team of the related program
You drive cross-location quality activities
Good Bachelor degree or above in Computer Science, Information Systems, or related disciplines
Very high commitment to quality, reliability and a self-motivating style of working
Experience in test automation, respectively willingness to build up knowledge in this area
Fluent in English and German (both spoken and written)
5+ years of work experience in a quality role or similar experience

Senior Quality Specialist for Offshore Wind Farms Resume Examples & Samples

Take ownership of the lesson learned process
Facilitate lessons learned sessions and follow-up on implementation of lessons learned actions
Be the deputy administrator for management of change processes
Support the ISO9001/55001 process development
Assist in the ISO9001/55001 internal audits
Support in development of business processes within Wind Power Operations
Have a master's degree in an engineering discipline or management qualifications
Have extensive experience of ISO9001 and/or ISO55001
Have lead auditor training
Have a proactive and systematic approach to your work tasks
Are able to create good relationships with your stakeholders
Have worked in a quality management department

Senior Quality Specialist Resume Examples & Samples

Responsible for review and approval of the following types of documents, relating to area functions
Incursions
QC data
Raw material tests
Reviews procedures, policies and other instructional documents to ensure compliance with company policy and local and international regulatory requirements
Actively participate in continuous improvement initiatives
Collaborates with functional departments to resolve issues and maintain compliance
Training of personnel on quality system processes
Requires BSc/BEng in scientific discipline or related field with 8+ years of relevant work experience in pharmaceutical or related industry. Biologics manufacturing experience desired

Senior Quality Specialist Resume Examples & Samples

Apply Good manufacturing Principles in all areas of responsibility
Demonstrate and promotes the company vision
Maintaining current equipment and facilities qualification documentation
Perform impact analysis of changes to facilities and equipment
Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards
Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s)
Drives continuous improvement to the site’s equipment and facilities qualification/validation program
Assist in the authoring of site procedures related to equipment and facilities as required
Monitor the site’s calibration program
Monitor the site’s preventative maintenance program
Author qualification documents as required
Other duties may be assigned to meet business/compliance needs
Minimum Qualifications
A minimum of 5 years in the pharmaceutical/related regulated industry
Experience with equipment and facilities validation Quality Systems
Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation
Possess the ability to use sound judgment in discerning if equipment and facilities qualification documentation accurately and completely reflects the documentation and requirements of the system
Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance
Thorough understanding of regulatory documentation requirements
Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products
Experience in Microsoft Word, Excel, and Power Point

Senior Quality Specialist, QMS Resume Examples & Samples

Act as a QMS champion, facilitator, mentor and leader
Collaborate with local operations management and remote Quality management, to help define and document local process workflows into methods that effectively support site processing needs while concurrently demonstrating regulatory compliance
Provide ownership of the local CAPA, NCR, Complaint Handling, Document Control, and Quality Records, and quality metrics, and any other QMS function as assigned. Coordinate with operations QC function
Approve selected quality records and forms, as either originator/owner or in an oversight capacity
Communicate quality system effectiveness, opportunities for improvement, noncompliance, strengths, risks, etc., to the Quality Manager. Support and assist the Quality Manager, as assigned, in managing or mitigating in these areas
3 to 5 years of experience in a structured quality system environment (such as ISO 9001, ISO 13485, FDA part 820, FDA Part 210/211 or other), working in a Quality Department, preferably in a medical device environment
Experience and understanding of CAPA, complaint handling, nonconforming product (NCR) process, document control, Device History Record (DHR) product release, and quality system structure
Experience in fast paced and detail oriented environment heavy with requirements for complete and accurate documentation. Understanding of good documentation practices
Ability to successfully multitask
Organized, with good communication skills, and attention to detail
Team player, but resolute when needed, comfortable reporting to remote management
Comfortable making decisions within assigned authority, comfortable to escalate when needed
Able to train or mentor others that are new to quality system functions or practices
Quality systems internal auditor training or certification
Computer skills, Microsoft Office, Word, Excel, other as needed
American Society for Quality (ASQ) certification (to? CQE, CQM?)
In depth knowledge of 21 CFR Part 820 and/or 21 CFR Part 210/211
Experience with process validation including generating protocols, test scripts and writing final reports is strongly desired
Familiar with FMEA methodology

Senior Quality Specialist / Quality Expert Resume Examples & Samples

Fluent in English (both spoken and written)
Fluent in Czech (proficient or native level)
0 -10%

Senior Quality Specialist Resume Examples & Samples

Facilitate development and maintainence of the quality management system according to ISO, MDD and FDA requirements
Maintain the CAPA system to ensure proper notification, impact assessment, root cause analysis, investigations and effectiveness verifications to ensure all requirements are met
Perform complaint handling, including root cause analysis, investigations, corrective action determinations, and as appropriate, adverse event determinations and reporting
Provide system administration duties and technical interface with consultants to support and maintain the Manufacturing Pro database, including software changes and re-validation acitivities
Perform audits/assessments internally and of suppliers for compliance to quality system and regulatory requirements. Support internal and external audits as well as follow through on audit responses
Maintain the PIR process, including compliance to procedures, timelines, and reporting to BSC
Lead special projects that require Quality Assurance expertise including improvements to quality systems
Perform trending of data and quality systems as relates to annual reporting, management metrics and other trending, as required
ASQ (or similar) certification preferred
Strong presentation skills and MS Office skills
Experience with major systems (e.g. eCAPA, PDM, CRD, SAP, VIP, Clarizen) desirable
Strong analytical and investigation skills

Senior Quality Specialist Resume Examples & Samples

Serves as QI specialist for the quality program with the goal to meet customer requirements and performance guarantees. Duties include coordinating Quality/ Accreditation/Delegated initiatives and project plans, monitoring and execution to meet timely deliverables
Provides direct interventions with members and providers to address gaps in care
Develops, in collaboration with the customer and communication department, informational and training materials for providers and members
Coordinates with any vendors outreach and interventions
Prepares status reports on activities and outcomes of interventions and activities
Consults and trains staff on measurement specifications
Provide assistance as needed in data maximization efforts through coordination with the company Central HEDIS team
Coordinates CQI (continuous quality improvement) processes and studies related to improved outcomes
Provides interface with customers, National Quality/Clinical and CCOE staff for HEDIS planning, reporting and program enhancements

Senior Quality Specialist Resume Examples & Samples

Leads Regional Management Reviews with APAC EPD leaders
Experience of using statistical tools to track and trend the Quality metrics
Creates and maintains data, documentation and systems to track, monitor, and support the divisional metrics and management review program. Monitor regional quality metrics and performance by gathering relevant data and producing statistical reports to support decision process of continual improvement activities
Analyze Quality performance metrics for site and above site level and as regional coordinator and act as bridge between division and sites
Ensure CAPA (Corrective Actions/ Preventive Actions) for the action items indicated through are addressed and successfully implemented
Interacts with regional functions and represents APAC EPD on divisional initiatives related to Training, Metrics and Management Reviews. Participates in developing/improving compliance against the metrics for APAC EPD
Publishes EPD regional metrics to division QA, as requested
Establishes regional requirements for the EPD Training Quality System. Creates training materials and delivers training, as requested
Liaison to sites and other regions for training, metrics, and management review topics
Leads process improvements, strategic programs, risk assessments and other projects related to training, metrics, and management review
Establishes, maintains and optimizes region wide processes related to metrics, management review, and training
Supports APAC Quality Systems on strategic initiatives
Strong knowledge of relevant regulations for quality systems and compliance. Should have solid understanding of Quality Management System Principles
Proficient with Microsoft Office Suite (intermediate MS Excel knowledge required), Adobe Acrobat, Visio, PowerPoint presentation skills. Experience of using Track wise -SolTRAQ, ISOtrain, and General IT system data entry and report generation is desired
Excellent verbal and written communication skills, interpersonal skills, and project management skills. Solid English language ability. Experience of working with people across geographies will be an added advantage
Minimum 7+ years of experience in the GMP/ Pharmaceutical industry
Experience to include, writing and maintaining quality system documents
Demonstrated problem-solving and decision-making abilities

Senior Quality Specialist Resume Examples & Samples

Review nonconformance request, customer complaints
Conduct Nonconformance investigations to understand issues and identify root causes
Write Nonconformance documents and reports
Lead Nonconformance investigation activities and coordinate material board review meetings

Senior Quality Specialist Resume Examples & Samples

Design and implement a quality governance process for the development teams
Steer quality processes and test execution for development teams in Brno and Bangalore
Close monitoring of and reporting over product and cloud quality KPIs
Expert guidance on quality topics in close collaboration with your senior team members
Define and deliver the quality goals, quality strategy and standards in line with the overall quality and test framework
Coordinate, foster and lead the QE colleagues and test engineers
Coach and support the teams of the respective delivery program to produce usable software each tact and reach defined cloud or on premise qualities
You have a profound quality background and have shown excellence in a QE/QPE and QPA role. You have a proven, successful track record in leading quality-related projects or workgroups
Excellent understanding of I2M, SAP’s quality standards and processes and its execution
Knowledge and experience in Frontend test automation tools is a strong advantage
Practical experience in software development and Agile methodologies are required
Must be a team player and have excellent written and oral communication skills
Highly proficient in both spoken and written English and German

Senior Quality Specialist, Documentation Resume Examples & Samples

Maintain an effective change and version control of all documents
Support NDP pipeline projects
Assist with reporting and analysis of Change Control metrics
Assist in the creation and development of metrics to evaluate the effectiveness and efficiency of Document Change Control Processes
Follows all standard operating procedures
Prior exposure to various functions of corporate organization is preferred
Performs other duties assigned as needed
A combination of one of the following is required

Senior Quality Specialist Resume Examples & Samples

Assists or supervises others in the organization within assigned technical areas of responsibility
Provides technical and decision-making support and/or data analysis in managing situations and issues relative to quality and/or food safety
Conduct quality and food safety audits, individually or as part of a team, at Conagra processing facilities, suppliers, and contract manufacturers
Collaborates and provides technical support to appropriate functions and employees to assure, food safety and quality of company products
Gauges and evaluates effectiveness and assure continuous improvements in assigned areas of responsibility
Execute appropriate inspection criteria to determine degree of compliance
Assist on audit summary calls as needed
May communicate with facility leadership teams and Platform Quality throughout all phases of the audit process
Incumbent must be able to work under direct or indirect supervision
Must follow the travel and expense policy and in accordance with the budget
Minimum of 5 -7 years’ industry experience required
Demonstrated strength in setting a good example for others

Senior Quality Specialist Resume Examples & Samples

Design efficient test strategies
Provide quality reviews throughout the software development lifecycle
Coach team members and stakeholders in the area of quality
Evaluate and integrate software quality tools into the quality processes
Monitor test results
Actively improve SAP Hybris’ software quality processes

Senior Quality Specialist Resume Examples & Samples

Quality representative on Category Commercialization Teams, ensuring all Category products meet design, food safety and quality policy requirements as defined by the I2M commercialization process
Provide leadership on driving quality programs and training with business partners in areas including QCMS, Integrated Lean Six Sigma, product traceability, net weight control, HACCP, GMP’s, Control of non-conforming product
Works with R&D to help design specifications and capability to bring consumer inspired quality to life
Monitors, reports consumer contacts/trends and identifies and directs appropriate corrective/preventive action plans with cross functional partners (R&D, Marketing, Operations)
Leads Quality programs and training at manufacturing sites: QCMS, product traceability, weight control, HACCP, GMPs, Plant QIPs, Sanitation and Regulatory Compliance. Facilitates sharing of best practices between different sites
Provides audit support to sites and facilitates identified corrective/preventive action plans
Contributes to the management of special situations / early warnings with respect to plant investigations, root cause analysis and follow-up for the SSMT, protecting Mondelez International and consumers
Supporting NA Region and Categories in developing roadmaps for delivery of the consumer quality strategy
Thought leadership on long term strategic direction of consumer quality to be able to deliver long term planning and execution of consumer quality – resulting in clear pipeline of activities to sustain a rolling, multi-year strategic activity plan
B.S. degree in Food Science, Engineering, Microbiology, Chemistry or other related Sciences
2 or more years of related experience in Business Operations, Quality and/or R&D
Knowledge of Mondelēz International Quality policies/procedures
Knowledge of statistical processes and problem solving techniques
Plant Quality Team Experience
Knowledge of Office programs such as Excel, PowerPoint, Word, OneNote
Must be willing to travel 10-30% of the time

Senior Quality Specialist Resume Examples & Samples

Knowledge of National and International Regulations and Drug Development processes
Strong computer skills including Microsoft Office and Clinical Trial Management System (CTMS) applications
Excellent problem solving skills
Ability to lead and motivate a clinical team
Bachelor's degree in life sciences or equivalent nursing qualification with a minimum of 5 years’ experience in Clinical Monitoring including at least 2 years’ experience in a role equivalent to a Clinical Project Manager/Clinical Team Lead preferably within Quintiles; or equivalent combination of education, training and experience

Senior Quality Specialist Resume Examples & Samples

Provides to the site knowledge and experience in Quality Systems
Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks
Provides compliance contribution to project teams and leads small projects
Coaches and guides colleagues within the site
Responds to non-standard requests from customer needs
Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed
Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable
Participation in and leading internal inspections
Supplier management oversight
Ensures supply of high quality product through the implementation and oversight of the Quality Management System for the site
Champion the highest Quality and Compliance standards for the site
Ensure highest safety standards
Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation
3 - 5 years experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function
Quality Assurance SME knowledge, from both operational and educational experience, is required
Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
Demonstrated ability to work and succeed within teams as well as leading small project teams
Proven track record of providing independent Quality support to the site
Demonstrated coaching skills
Desirable evidence of Continuous Professional Development
Qualified Auditor

Senior Quality Specialist Resume Examples & Samples

Three (3) years of experience in an area or areas relevant to the assignment
Knowledge of the development, implementation and maintenance of quality management systems
Skilled in conducting testing and statistical analysis applicable to quality management
Ability to analyze information of considerable difficulty and draw valid conclusions
Ability to communicate effectively, orally and in writing
Ability to understand and apply verbal and written work and safety-related instructions and procedures given in English
Ability to communicate in English with respect to job assignments, job procedures, and applicable safety standards
Work is performed in a mine or manufacturing plant setting, which may include exposure to extremes in temperature and humidity, moving mechanical parts, risk of electrical shock, toxic chemicals, explosives, fumes or airborne particles
While performing the duties of this job, the employee is required to stand, sit, demonstrate manual dexterity, climb stairs and ladders, and work on elevated platforms
Occasionally may be required to lift moderately heavy objects (up to 30 pounds) during the course of the workday
May be required to work rotating shifts in a 24/7/365 operation
Freeport-McMoRan promotes a drug/alcohol free work environment through the use of mandatory pre-employment drug testing and on-going random drug testing as per applicable State Laws
Positions which are held by employees who operate equipment, machinery or motor vehicles in furtherance of performing the essential functions of their job duties, including operating motor vehicles while on Company business or travel (for this purpose “motor vehicles” includes Company owned or leased motor vehicles and personal motor vehicles used by employees in furtherance of Company business or while on Company travel); or

Senior Quality Specialist Resume Examples & Samples

Ensure compliance to external (regulatory) requirements, including Quality Management Systems (ISO 9001:2008, ISO 13485:2003/2012, ISO 13488 CMDCAS, Quality Systems Regulation) and the In Vitro Diagnostics Directive and that the requirements are communicated to all staff
Maintain compliance to the requirements of Dartford’s Quality System and ensuring the Quality Assurance team meets the QMS objectives for the site
Responsible for reviewing and approving quality documents in line with local quality procedures
Undertake QA responsibilities regarding failure investigations, hold and recall investigations, risk assessments and field actions, ensuring all necessary review are timely documented and completed
Perform internal audit to ensure compliance to external regulatory requirements
Provide metric data for Management Meetings and measurement of site quality goals
Provide technical and Quality support of projects, ensuring relevant data is completed
Participate in the audits of Remel Europe by third parties (e.g. Oxoid, Remel, BSI, FDA) and ensure corrective actions are implemented for issues arising from the audits
Provide support for on-going management of Master Control
Assist with mentoring and leading a small team of Quality Assurance professionals
Lead in the role of Risk Management and PMS; with knowledge of ISO14791
Deputise for the Quality Manager in their absence
Responsible for familiarising and complying with all health, safety and environmental rules, policies, procedures and any other instruction relevant to working within their area of the company
Any other duties/projects as are reasonable and within the skills and ability of the post-holder

Senior Quality Specialist Resume Examples & Samples

Review, evaluate, and investigate product complaints relative to the identity, quality, safety, and effectiveness of medical products
Identify, generate and publish metrics and reports related to the Complaint Handling, MDR and Vigilance reporting issues
Follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information
Support complaint handling in internal and external audits and inspections.Ensure complaint investigations are adequate, accurate, detailed and timely
Analyze events reported from multiple inputs to determine complaint status and regulatory reporting
Analyze and report data using spreadsheets, graphs, and databases
Drive continuous improvement of the Quality System
Bachelors’ degree (plus 3-5 years relevant experience) or an Associate’s degree (plus 5 to 8 years relevant experience) in clinical/medical discipline, engineering or science
3 - 5 years related experience in post-market vigilance/surveillance/complaints with medical devices
Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.)
Medical device experience is a must
Must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective
Previous experience in legal, technical or medically related area preferred
Demonstrated use of quality tools methodologies, and strong computer skills

Samg Senior Quality Specialist PRN Days Resume Examples & Samples

Bachelor’s Degree required, preferably in a health care related field
RN preferred
Minimum of three to five years’ experience in quality, safety, or clinical care preferred
Strong computer skills with an emphasis on MS Word, Excel, Access, and PowerPoint
Working knowledge of electronic medical records
Ability to read and interpret licensure, accreditation (The Joint Commission) and regulatory standards
Knowledge of performance improvement and Lean methodologies preferred
Familiarity with principles of root cause analysis (RCA) and able to facilitate root cause analysis
Competency in multiple areas preferred, including group facilitation and leadership, process improvement methodologies as above, adult education and knowledge of healthcare organizational processes
Must be able to provide own means of transportation to different locations throughout the day
Meets medical center’s Guiding Behaviors and Caring Standards including interpersonal communication and professional conduct expectations with all co-workers, other departments, and with patients and visitors
Remains current on best practices on clinical issues relative to areas of responsibility
Maintains knowledge of The Joint Commission (TJC) regulations and requirements, applicable CMS requirements, and payer requirements and has the ability to interpret and give guidance on fulfillment of these requirements
Educate clinic staff and providers on performance measures based on quality metrics and regulatory issues (such as TJC and CMS requirements and CMS/payer quality initiatives, value based modifier programs, etc.)
Creates educational tools around regulatory requirements, Performance Improvement (PI) methodologies, and quality and safety goals for the organization, and has the ability to teach others to teach these subjects
Able to examine performance and identify opportunities for improvement, meets with the teams, facilitates the groups, and takes data to action and results
Conducts Lean projects as directed
Performs, leads and facilitates root cause analyses as directed
Assists SAHS risk management as directed by SAMG Director of Quality
Supports orientation to Quality and Regulatory requirements for SAMG staff as directed
Supports various councils within SAHS and SAMG as directed, such as the Triad Council and the Boise Unified Care Organization (UCO) Ministry team
Supports and leads CHE Trinity Health collaboratives that impact SAMG, as directed
Assists in patient care excellence and Culture of Safety surveys as directed by the SAMG Director of Quality
Assists in teaching Patient Centered Medical Home (PCMH) concepts, creating policies, and applying work flow lean expertise to SAMG clinics pursuing PCMH status

Senior Quality Specialist Resume Examples & Samples

Manage Noncompliance Occurrences (NCOs) and Significant Unplanned Deviation Reports (SUDRs) in the Lifecycle Safety Deviation Noncompliance Quality Assurance (DNCQA) area in the Event Driven Analysis (EDA) database
Review and close completed SUDRs ensuring all text is clear, root cause analysis is comprehensive and all actions to address the root cause will prevent the re-occurrence of the root cause and have been thoroughly executed
Provide metrics and complete trend analysis of DNCQA data at department, functional group and customer level
Support Lifecycle SOP Management, Training Management and Business Continuity Management as needed
Provided dedicated Quality Management support to two or more Lifecycle Safety’s functional areas including quality improvement initiatives, quality control processes and responding to and closing out CAPA findings
Assist with customer audits and inspection by regulatory authorities including provide audit conduct training to staff, reviewing project files, facilitating case and report walk through, practice audit presentation with Pharmacovigilance Lead and functional leads, review audit agenda and ensure all staff are prepared and document requests have been completed, attend audit or support audit remotely, review audit reports and assist with audit responses as needed
Provided dedicated Quality Management support to selected projects/customers including contributing and reviewing Quality Management Plans, provide ongoing oversight of compliance and quality goals for project, attend customer meetings, review all NCOs and SUDRs for project and provide DNCQA database metrics
Provide support to Qualified Person for Pharmacovigilance (QPPV) staff including providing information on SUDRS related to their customers along with contributing and reviewing Pharmacovigilance System Master Files (PSMF)
Attend and contribute to monthly Regional Quality Lead meetings
Participate in the review of Planned Deviation Requests
Perform Lifecycle Safety-Assessment of Changes to Regulatory Rules as assigned
Completes ad hoc requests as needed
Work closely with QA on customer audits, internal audits and management of QA quality issues for the department

Senior Quality Specialist Resume Examples & Samples

Determine appropriate quality system and implement processes and procedures across the organization. Oversees the quality system to ensure it is suitable, adequate and effective
Coordinates cross-functional activities (Hardware, Software, Marketing, Manufacturing, Service, etc.) to achieve compliance with all appropriate quality system and regulatory requirements (internal and external)
Leads the culture change and is able to achieve site-wide program success through measurable activity and metrics
Strong ability to lead cross-functional team in the execution and reporting of quality improvement projects in the area of focus. This includes but is not limited to: working with teams to perform and document the Risk Management activities, plan and conduct internal and supplier audits, interpret regulator requirements and implement processes to meet those requirements. Divisional and corporate regulatory affairs personnel to clarify requirements as necessary
Establish and use Key Business Indicators (KBI) to determine process effectiveness, identify areas for improvement, implement best practices and drive continuous improvement
Drives consistent Quality tools across the business unit
Establish and participate in appropriate supplier qualification/development activities to ensure that products meet design and manufacturing and quality requirements
Evaluate and implement protocols and methods to ensure that incoming material and manufactured products are compliant with internal requirements as well as the standards/regulations for worldwide distribution
Perform analysis of reports to identify trends and recommend necessary corrective actions
Drive corrective, preventative, and closure actions for project issues related to quality and/or test non-conformances
Active involvement and support in internal and external audits
Communicates with customers on as needed basis for significant and reoccurring quality issues
College diploma or University degree in Quality Management, Electrical, Mechanical or Manufacturing engineering
ASQ Black Belt or Green Belt certification CQE, CQA or CQM or other related certifications are preferred
Experience applying a variety of tools and techniques that lead to significant product quality, manufacturing and cost improvement is required
3-5 years’ experience in a Quality position, preferably in an ISO environment
3-5 years’ experience with Quality Management Systems, ISO 9001:2000, FAI, CAPA programs & Continual Improvement implementation
2-3 years experience as an Internal ISO 9001:2000 Auditor
Experienced with the use and care of precision measuring equipment, interpretation of engineering drawings, and specifications
Excellent working knowledge of Microsoft Word, Excel and PowerPoint
Clear communicator with a strong attention to detail, works well under minimal supervision, positive, outgoing, able to teach and work well with others

Senior Quality Specialist Resume Examples & Samples

A minimum of a Bachelor’s Degree is required
A Bachelor’s Degree in a science, engineering, nursing, or biomedical engineering related fields is preferred
A minimum of 2 years’ experience in a GMP and/or ISO regulated industry is required
Direct experience in a medical device quality and/or medical device product development role is preferred
Experience with Medical Device (MDR) and/or Vigilance reporting is required
Experience conducting and reviewing product complaint investigations are preferred
Post market regulatory, quality and/or compliance experience is preferred
Being highly organized with the ability to prioritize job functions with attention to detail and within required timeframes is required
Strong written and oral communication and interpersonal (listening) skills are required
The ability to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision making is required
RAC or ASQ certifications are preferred
Familiarity with basic quality tools and techniques, EtQ or similar system is preferred
Analytical and critical thinking skills are required

Senior Quality Specialist Resume Examples & Samples

Project Support -- Participates on project teams developing, designing, installing and starting up new products, product improvements, and technology upgrades to ensure quality is consistently delivered.65%
Issue Support & Management - Resource and technical knowledge for Troubleshooting and problem resolution. Provides operational support and analytical problem solving at Supplier and Clorox locations, drawing in internal and external experts as appropriate, managing improvement plans and activities. 15%
Perform Quality Systems Assessments & Audits - Performs Quality System Assessments of Clorox manufacturing facilities, suppliers and co-packers. 10%
Drive Continuous Improvement - Supports the continuous improvement of the Quality function by identifying and resolving gaps in quality systems, tools, and processes. This role develops, implements, maintains, and improves quality systems and processes. 10%
5+ years of professional experience with a minimum of 2 years' experience in Quality and/or Operations
Knowledge of quality systems, including statistical process control. ISO 9000 systems knowledge a plus
Auditing experience, certification preferred
Strong independent leadership skills. Will be required to travel independently to worldwide sites
Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
Strong interpersonal skills. Will be required to represent the function on project teams
Strong problems solving skills, issue resolution and root cause analysis
Strong written and verbal business communication skills
WCO/ Lean Mfg / TPM experience desired
Ability to travel 35% of the time or more

Senior Quality Specialist Resume Examples & Samples

Bachelor’s degree (B.A. or B.S.) from a 4-yr college
1+ years of experience with knowledge of quality systems
Masters Degree or MSc preferred
Professional Certifications preferred
1+ years of experience with knowledge of medical/ healthcare industry helpful
Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from managers, customers. Ability to interface successfully with health care professional customers
Mathematical Skills
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio and percent and to draw and interpret bar graphs.Ability to identify and interpret trends
Reasoning Ability
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical data

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Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

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Senior Quality Specialist Resume Examples & Samples

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Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

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Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

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Senior Quality Specialist Resume Examples & Samples

Senior Quality Specialist Resume Examples & Samples

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