Manager, QA Resume Samples

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L Moen

Lexi

Moen

1214 Joelle Views

Philadelphia

+1 (555) 179 7240

1214 Joelle Views

Philadelphia

Phone

p +1 (555) 179 7240

Experience Experience

San Francisco, CA

Manager QA

San Francisco, CA

Jacobson-O'Kon

San Francisco, CA

Manager QA

Responsible for hiring, training, supervising and performance management of staff
May perform work of QA Specialist
Support Quality Operation (warehousing operations, 3PL management, audits, distributor management practices etc.) and collaborate with CLS quality
May perform or oversee the following functions
Manages documentation critical to quality systems, compliance and formulation
Support Quality Improvement Processes, Affirmative Action objectives and all activities to achieve Various Quality Objectives
Oversees quality assurance auditing of service providers and systems (Supplier audit and Internal Audit)

Dallas, TX

Manager, QA

Dallas, TX

Jerde LLC

Dallas, TX

Manager, QA

Defining, implementing, and maintaining best-of-class test engineering strategies, procedures and tools to enhance quality engineering and productivity
Resource allocation, capacity planning, scheduling, risk management, issue resolution and productivity metrics tracking
Mentoring and leading their team to deliver features and updates to the site on schedule while achieving high quality objectives
Lead career planning/development and personnel decisions, including hiring and performance evaluations
Lead acceptance testing of new or existing products
Define the next generation test engineering and automation strategy for the assigned programs and features as well as oversee its implementation
Leads quality planning activities for new product development

present

Philadelphia, PA

Manager QA RTC

Philadelphia, PA

Effertz and Sons

present

Philadelphia, PA

Manager QA RTC

present

Manages people through effective performance management and labour relations excellence
Performs trend analysis on different quality systems to support QA Operations to further improve the systems and results
Contributes to Inter MPU meetings to share and review trending results as to foster continuous improvement and manage risks
As a leader, personally role models and develops the team towards high performance behaviours
People Management & Development
Timely escalates critical non compliance and compliance/quality risks within the MPU to management and manages these risks through the risk register process
Ensures compliance of MPU processes with cCMP's and GSK Vaccines Belgium Quality Management System

Education Education

Bachelor’s Degree in Computer Science

Emory University

Bachelor’s Degree in Computer Science

Skills Skills

Practical knowledge and application of food safety principles such as HACCP, GMPs, etc
Implementing quality systems and effective auditing procedures
Quality data collection and analysis
Experience with regulatory agencies such as FDA, USDA or State Health Dept
Technical competence in microbiology
Experience with Global Food Standard Initiative (such as BRC, ISO, SQF)
Working conditions are typical of a food processing environment with offices and manufacturing processes Environment contains high noise areas, stairs, platforms, forklift traffic, wet floors, congestion and exposure to ingredients such as seasonings

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Associate Manager, QA Resume Examples & Samples

Auditing GMP Facilities
Lead team that conducts scheduled inspections of vendor plants, equipment, and personnel to evaluate and ensure cGMP compliance and social accountability
Directs and assists in investigations, internal audits, deviations, and corrective actions of GMP facilities
Responsible for the determination of vendors ranking that will determine business placement for all LVMH groups
Management of quality defects
Assessing and negotiating liability with vendors for quality failures
Work with customer to get all necessary data and samples to disposition or correct issue
Develop and maintain KPI reports to track defect trends
Manage communications (verbal or written), both internally and externally, for effective resolution of quality defects
Interact with internal team members and external personnel on matters requiring coordination between organizations and issue resolution
Resolve issues as they arise during New Product Development cycle by identifying potential problems in sufficient time for corrective action to be taken
Identity risks project timing and proposing sound/effective solutions
Facilitate the “Project Handoff” meetings and call out project agreement and risk factors
Lead the “Ready of Production” meetings with project team to ensure production success
With the assistance of the technical teams, determine the root cause of quality defects and implement Action plans to prevent future repeats
Develop and maintain reports that will track these effectiveness of these Action plans
Manage FDA and Health Canada product registrations
Communicate with governmental bodies to ensure product registrations are granted and resolve any issues that may arise
Identify improvement areas and create best practices for continued improvement of Quality Assurance functions
Oversee and supervise performance of Quality Assurance Analyst
BA/BS degree. Science or Engineering field preferred
2-3 years of experience Quality Assurance. Cosmetics / Consumer Packaged Goods industries preferred
Experience in managing multiple projects involving Contract Manufacturers and adapt to changing priorities
Strong organizational and analytical skills a must
Knowledge of MS tools a must
Working knowledge of cGMP, GMP, and FDA CFR parts 210 and 211
Experience auditing GMP facilities for cosmetic manufacture
Demonstrated technical writing ability including: revising/authoring procedures, initiating and writing investigations, writing response to customer complaints
Demonstrated ability to read and comprehend written technical procedures as well as revise SOPs as needed
Demonstrated ability to comprehend, interpret, enforce and apply written Good Manufacturing Practices and Standard Operating Procedures
Strong organizational skills (demonstrated ability to prioritize and focus to meet deadlines) and result-oriented Ability to prioritize work and multiple projects to meet deadlines and deliver excellent results
Excellent written and verbal communication skills with ability to summarize, understand, relate, and explain technical content for specific audiences
Team-oriented with mind open to concepts and suggestions from others
Fluent in English usage, spelling, grammar, and punctuation
Ability to prioritize work and multiple projects to meet deadlines and deliver excellent results
Ability to effectively communicate (verbal and written) with team members and contract manufactures (domestic and international)
Critical thinking/problem solving – ability to identify issues, make recommendations, and meet deadlines without sacrificing quality
Leadership – ability to motivate and drive team to perform at their best

Manager, QA Resume Examples & Samples

Lead the espn.com QA team
Provides Quality Engineering input through all parts of the SDLC
Participates in new product roadmap and technical design reviews
Leads quality assessment reviews and slippage analysis efforts
Foster and support a culture of innovation and excellence within the organization
Lead career planning/development and personnel decisions, including hiring and performance evaluations
Help define and report metrics on product quality
Recommend process improvements and implement change
Manage remote teams and off-shore partners
A minimum of 8 years of Quality and product release experience
QA expertise working in various software delivery models, waterfall, iterative, and Agile
Demonstrated ability to drive results with urgency
Demonstrated strong collaboration and positive influence skills
A minimum of 3 years of managing QA staff
Demonstrated strong experience with vendor partner management
Proven ability to drive vendor partners to deliver high quality results on time and within budget

Engineering Services Manager, QA / QC Resume Examples & Samples

Provide leadership in the development of SHDR Quality Assurance Department
Lead the activities of Quality Assurance Inspectors, Technicians, and 3rd party outside inspection contractors
Maintain the qualification and certification program for Quality Assurance Cast Members and Welders
Develop and maintain calibration program for tools and equipment’s
Maintain processes that assure that in-house and outside manufacturing and inspection of safety-related components and assemblies are in accordance with Engineering and regulatory requirements
Comply with all applicable engineering and government requirements
Demonstrate a visible commitment to safety
Coordinate with SHDR Partners that include Engineering Services Teams and the Overhaul Program to complete complex inspection requirements
Coordinate with Partners to develop schedules and resources required to complete inspections
Direct the activities of Inspectors and Technicians in the performance of required inspections. Inspectors and Technicians are either Cast Members or 3rd party contractors
Provide Inspectors and Technicians with training, procedures, and the necessary inspection equipment in order to enable the completion of required inspection and testing. This includes administering the inspection equipment maintenance and calibration program
Review documentation and reports for accuracy and compliance with procedures and regulatory requirements
Support Disney periodic audits and the annual ride certifications
Work with Suppliers and Shops to resolve quality related issues
Maintain qualification and certification program for Quality Assurance Cast Members and the qualification of welders and welding processes
Ensure compliance with Corporate, Environmental Practices Agency, legal/regulatory standards. Prepare the team members training plan, and willing to coach technicians with different training resources
Complete other assignments as deemed appropriate by their Manager
Approximately 10+ years of experience in Quality Assurance
Having 5+ years of leadership experience
Understanding of inspection methods that include (MT) magnetic particle, (PT) liquid dye penetrant, (UT) ultrasonic, (ET) eddy current, and (VT) visual testing
Understanding of dimensional, receiving and in-process inspection, welding requirements and processes
Experience in dealing with regulatory agencies
Knowledge of Computerized Maintenance Management Systems (CMMS); and/or other Quality Assurance system
Excellent interpersonal skills (partnering, mentoring, coaching, etc.) in diverse culture working environment
Written and verbal communication skills in both Chinese and English
Possess a high technical aptitude and sound decision making skills
Able to read drawings and schematics
Able to develop management reports, accurately report information, and deliver good quality maintenance on time
Strong computer skills (MS Word, Excel, Power Point, etc.)
Ability to interact with various levels within the company and outside agencies. (Front Line Maintenance Staff, Support Staff, Managers, Engineers, Vendors , and Government Agencies)
Available to work all shifts (i.e., 1st, 2nd, and 3rd shift), weekends and holidays as deemed required by management
Bachelor Degree in an Engineering or Technical discipline (Mechanical or Electrical Engineering is preferred

Manager, QA Resume Examples & Samples

Defining, implementing, and maintaining best-of-class test engineering strategies, procedures and tools to enhance quality engineering and productivity . Solve test engineering challenges to draw higher efficiency and effectiveness from the team
Driving measurable change in the company’s product and code quality
Resource allocation, capacity planning, scheduling, risk management, issue resolution and productivity metrics tracking
Mentoring and leading their team to deliver features and updates to the site on schedule while achieving high quality objectives
Define the next generation test engineering and automation strategy for the assigned programs and features as well as oversee its implementation.- Performance reviews, compensation, career planning and recruiting new talent as required to manage varying work load
6+ years experience in leading engineering and quality teams
10+ years hands-on experience in requirements analysis, design, coding and unit testing of scalable, distributed, multi-tiered, fault-tolerant applications in Windows and UNIX environments
3+ years experience in working on high-volume web / eCommerce capabilities
3+ years object-oriented design methodology and application development in Java and J2EE, including servlets, JS, JDBC
Expertise required in design and implementation using relational databases (prefer Oracle)
Exposure to Ajax technologies desired
Outstanding presentation and written skills as well as the ability to deal effectively with both technologists and business representatives
Proven results oriented person with a delivery focus
Good time management and ability to work on concurrent assignments with different priorities
Excellent risk management skills
Ability to facilitate cross functional team communications
Self-motivated and able to work independently, and be able to thrive in a multifaceted fast-pace, global development environment

Manager, QA, UA Digital Resume Examples & Samples

Own overall Quality Assurance for a sophisticated suite of connected partner devices
Management of user acceptance testing (UAT) for Connected Fitness
Manage Services, Construction and Maintenance of User Acceptance Testing tools and processes
Manage device inventory
Coordination of test planning and test execution of user acceptance tests in cooperation with Colleagues in Baltimore (USA)
Define and implement overall QA program metrics, processes, and communications
Regularly report overall QA status and timeline
Develop a culture of QA that “raises the bar” on internal and external expectations of quality by taking a consumer-centric point of view
Grow the QA program and team to align with business goals
Identify and manage defects, risks, and issues to the program
Help reproduce, triage, and drive resolution of system defects
Apply a broad understanding of hardware and software to expedite solutions and triage by identifying the team that should own the issue quickly
Be the gatekeeper for the Under Armour UGOP relative to connected software and hardware
Work relentlessly towards creating an excellent end-to-end consumer experience

Manager QA Clinical Release Resume Examples & Samples

55% To provide QA support for the manufacture, packaging and of clinical trial materials. To assure drug product, documentation, and data related to the manufacturing, packaging, labeling, and testing of clinical and commercial drug products are compliant with all GMP, SOP, CTA, and regulatory requirements
15% To ensure QP certification of drug products to be used, imported to or exported from the EU by coordinating certification activities with IMP QPs to assure seamless release and certification of drug products as appropriate
20% To foster communication with key Shire stakeholders in order to properly plan and prioritize workload and to coordinate technical information and queries. To coordinate and participate in meetings that support of department objectives. Foster the use of the Project Based Approach to record all documents that are needed to release material for a clinical study
10% To ensure deviations and OOS investigations are adequately investigated and documented. To ensure clinical complaints are adequately investigated and reported

Manager, QA Architecture Resume Examples & Samples

Experience with working with high volume web systems or large transaction client-server systems
Experience implementing innovative solutions that adhere to QA architectural goals and principles
Strong technical leadership and ability to command respect at all levels of the organization
Experience reviewing external test technologies and products for their applicability to specific projects or overall QA needs and is able to compare various solutions to select the one most appropriate for the project and company
Excellent communication and relationship skills, especially the ability to articulate
Advanced technical topics to both technical and non-technical staff
Business issues/concerns with staff, peers, superiors, and outside parties (e.g. vendors, partners)
8 years minimum work experience with relevant technologies and with designing, implementing, administering, and supporting QA test systems
Tools and processes for Load, Performance testing
Automated environment deployment
3+ years experience leading QA teams
3+ years experience in QA architecture
Defect Tracking Tools; i.e. JIRA
Test Case Management; i.e. Test Rail
Programming: Java, Javascript, C#, Python, Perl, and similar languages
REST APIs; JSON; XML
Operating Systems: Windows, Linux, OS X, iOS, Android
Databases: MS SQL and NoSQL/Mongo
Application Servers (Tomcat, JSP, Servlets)
Platform virtualization: VMware, AWS

Manager, QA Engineering Resume Examples & Samples

Direct product requirement testing for various programs by generating testing strategies and test plans
Develop new methods for product testing and automated test frameworks to gain efficiencies and support continuous integration
Develop performance testing strategies and plans to ensure system stability during high volumes
Review quality issues and risks and lead software development to resolve issues
Partner with cross-functional teams to design software and application design specifications prior to the actual creation to ensure accurate testing can be performed and the programs meet company standards
Ensure programs meet design specifications prior to their launch
Manage test schedule and ensure execution is completely on time
Manage troubleshooting and debug if issues escalate
Resolve any major issues with programs that could possibly affect data security, customer functionality, or system performance
Partner with software and application developers/engineers prior to development to ensure testing specifications are met
Write manuals for specific requirements to ensure accurate testing
Prepare reports and presentations for senior management and key stakeholders regarding product quality and performance
Train others in existing and newly implemented QA testing as needed
5+ years of experience in QA
Experience testing web based software and applications
Experience with JavaScript, Selenium, Appium, or other scripting language
Ecommerce experience a must
Retail experience a plus
Experience in Agile Methodologies a plus
Knowledge of retail processes and operations
Knowledge of e-commerce systems
Strong understanding of web technologies
Ability to communicate effectively within and across business units
Must be able to work towards multiple deadlines with shifting priorities

Manager, QA Resume Examples & Samples

Defining, implementing, and maintaining best-of-class test engineering strategies, procedures and tools to enhance quality engineering and productivity
Solve test engineering challenges to draw higher efficiency and effectiveness from the team
Define the next generation test engineering and automation strategy for the assigned programs and features as well as oversee its implementation
Performance reviews, compensation, career planning and recruiting new talent as required to manage varying work load

Manager QA / QC Resume Examples & Samples

Participate in development of overall annual plan and budget for the QA/QC laboratory in line with the business requirements. Ensure compliance of Lab Quality Systems to ISO/IEC 17025 standard as per NABL requirements and guide subordinates
Prepare and maintain the documents as per the requirements of the accreditation bodies. Represent laboratory discipline in the site meetings to review the performance and discuss relevant matters for plant process improvements
Ensure reliability and operational excellence with timely support to plants and other departments in both routine and emergency situations. Plan and conduct internal quality audits to improve Lab systems and take timely corrective/preventive actions
Participate in inter-site benchmarking and ensure best practices and corrective actions for improvements in coordination with Site Head QA-QC. Technology updation in the assigned discipline in consultation with Site Head QA/QC
Adopt and set up updated standard analytical methods / techniques as per customers specification requirements for products certification as required by QMS
Interface with cross functional teams for framing up sample schedules / sampling methods and test frequencies. Provide support in resolving testing issues/additional analytical support during start up, trouble shooting, test runs.Optimize and modify sample schedules to meet special requirements
Manage evaluation of process chemicals and additives and provide recommendations in vendor selection process with technical reports and data. Plan and monitor vender services for process/additive chemicals for performance evaluation
Use appropriate techniques (e.g. SQC) for lab analytical data analysis. Monitor and audit compliance with applicable HSEF procedures/ practices
Identify training need of lab team and ensure technical competency building in coordination with Site Head QA/QC. Fast corrective actions on instrumental / systems failures to ensure continuity of lab Services
Skill to improve laboratory and quality activities on a continuous basis
Works independently, takes independent actions on technical issues within the field of expertise
Analytical and Problem Solving with leadership quality & management skills
Technical Report writing with Good knowledge of process design and Understanding of process simulation tools
Key Attributes (Experience and Qualifications)
Qualification:B. Sc. Chemistry, Masters preferred

Manager, QA Development Resume Examples & Samples

Ensure that Global procedures are followed and aligned with local SOPs; responsible for maintaining harmonized processes for Quality support of BD&L projects during the Development phase
Provide Quality assurance for new products including BD&L projects by conducting risk-based quality assessments. Ensure that the compliance and quality risks are understood and are always an integral part of the business decision
Participate in the Review and Approval of Development documents for FDA submission including Analytical Development protocols and reports, Analytical Method transfers, product technical transfers, and Product Development Reports
Provide support for regulatory inspections, as required
Provide local metrics for US development activities, as needed
Implement guidances, SOPs, and templates for quality by design
Provide quality leadership to resolve analytical and process development issues
Work with the Regulatory Affairs and Scientific Affairs teams to provide Quality support for ANDA filings and deficiency responses
Oversee the development and implementation of Quality Agreements with service providers during product development stage
10 years pharmaceutical experience in a quality/compliance management role in a cGMP pharmaceutical manufacturing operations quality environment with preferred additional knowledge of EMEA/WHO GxP regulations preferred
Experience with CMOs
Preferred Clinical background

Manager, QA Validation, CMO Resume Examples & Samples

Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions to meet BioMarin and Agency requirements
Determine methods and procedures on new assignments with oversight from manager.Oversee and manage the activities of sub-teams
Lead and represent QA Validation in multi-departmental meetings & project teams owned by QA
Identifies and implements improvements to the QA Process Validation systems (department level impact)
Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal BioMarin laboratories
7+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control
1+ years experience in a position utilizing formal project management a plus

Manager QA GCP Resume Examples & Samples

B.S. degree in scientific, health care, or related discipline; and/or background in Medical Health Profession (RN, Medical technologist, etc.)
Five years’ pharmaceutical experience
Ability to travel up to 25%

Manager, QA Imp-gmp Resume Examples & Samples

BA/BS in chemistry, biology, microbiology, or allied sciences
Five years’ experience in pharmaceutical operations including first-hand knowledge of drug manufacturing, packaging, quality assurance, regulatory compliance, quality control laboratory operations, and regulatory affairs
Experience or knowledge of validation (i.e. physical, process and/or method) and data analysis
Experience or knowledge with Quality System Regulations desirable but not required (i.e. Medical device, companion diagnostics)
Understands current compliance practices and suggests innovative approaches to improve compliance and processes, including the incorporation of technology where applicable
Supports and effectively multi-tasks different, complex project- level assignments and responsibilities
Manages the development of solutions where errors, discrepancies, or inconsistencies have been identified and ensures project teams act accordingly
Strong ability to analyze complex data/situations and synthesize information into a clear conclusion; looks for additional explanations beyond the obvious
Develops professional relationships and networks within the function that create the foundation for personal credibility and trust
Strong interpersonal, leadership potential, enthusiasm and desire to grow desirable

Manager, QA Resume Examples & Samples

Administer the Global QMS certification program
Provide compliance leadership, oversight, and strategic guidance to drive notified body scheme management, integration activities and due diligence efforts
Develop and drive transition planning for the revised 13485 standard and regulations (Medical Device and In Vitro Diagnostic Device)
Partner with the business to develop and drive risk response programs
Manage the corporate quality system audit activities (schedule, plan, perform, follow up), may include travel to other sites
Develop and conduct Quality System Regulation, GMP, ISO and other targeted training programs to drive a quality culture across all levels
Administers the Corporate Quality Management Review program. Trend, analyze and report on global QMS Compliance
Accountable for the global regulatory inspection and third party audit program
Direct staff to provide optimal tactical readiness in response to on-site visits and inspections by regulatory agencies, certification associations and customers
Develop strategically and operationally effective response plans to Third Party/Customer audit findings
Handles difficult personnel situations directly, using appropriate discretion, HR advice, and respect for the individual
Other activities as assigned. All listed tasks and responsibilities are deemed as essential functions to this position; however, reasonable accommodations will be made if at all possible under business conditions

Associate Manager, QA Raw Materials Resume Examples & Samples

QC test data
Attends supplier audits and quarterly business reviews as needed
Excellent interpersonal, problem solving and leadership skills
BS in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with experience in a pharmaceutical/biologics manufacturing environment desired. Minimum 5 years experience in pharmaceutical industry; biologics experience preferred. Minimum 2 years experience in supervisory position

Process Supervision Manager, QA Resume Examples & Samples

Education - College or above education, or own intermediate professional knowledge
Related Experience – with 4 or above working experience in QA or TECH area in manufacturing industries. Know well in country policy/company regulation/paint product knowledge
English – Good English reading/writing ability
PC – be familiar with PC operation such as Microsoft office/Windows
Communication – Willing to communicate and sharing with others
Continuous Learning – Willing to learn new knowledge, challenge self
Team Work – Willing to share responsibility in a team and make progress together
LI-IRY

Manager, QA Internal Systems Resume Examples & Samples

Manage quality testing of internal systems such as SAP, Salesforce, and ecommerce and web based applications
Help define, implement, and maintain quality assurance methodologies and processes that all stakeholders can rally behind
Collaborate with QA Test Engineers, Engineering Managers, QA Managers, Product Managers, Project Managers and Scrum Masters in order to deliver compelling, high quality solutions via agile iterative sprint commitments
Introduce and implement and manage tools and process to better support execution
Manage ongoing continuous improvement projects
Define, implement, and maintain automation strategies that enable the team to perform more thorough regression testing of existing functionality, earlier in the release cycle
Interface with the Performance & Scalability team to ensure that performance and scalability is an integral component of all test strategies and project plans
Gather and communicate relevant quality assurance metrics and information, and provide status reports on sprint and release testing efforts

Manager QA Resume Examples & Samples

Act as a knowledge source for headquarters in Russian regulatory requirements area
Organize and hold regular phone and face-to-face meetings with headquarters and partners
Prepare CTAs and MAAs for assigned products and submit them in line with the regulatory plan
Review of regulatory documentation prepared by global regulatory department and by business partners, identify gaps and achieve their elimination
Prepare ND and packaging texts
Track of regulatory procedure in the state register
Maintain MAs through renewals and variations
Actively participate in obtaining necessary information/supplies from internal (or external) providers required for planning and performing regulatory activities
Prepare responses to deficiency letters received from the Russian regulatory authorities
Track changes in local and EU regulatory requirements and ensure compatibility of MAAs/CTAs to them

Manager, QA Packaging Resume Examples & Samples

Supervision of the QA Inspectors to assure the department responsibilities are being executed as per written instructions and in accordance with cGMP requirements. Oversee the sampling and inspection function for raw materials, packaging components and labeling
Act as a QA liaison between Quality and Supply Chain to ensure timely release of materials and scheduling of packaging
Oversee the Product/ Material systems. Perform SAP Transactions related to the disposition of raw materials and packaging components. Perform the final disposition for all incoming materials (components, raw materials and bulk)
Establish key quality metrics for the department and monitor performance in meeting objectives, efficiency standards and conformance to cGMP compliance regulations; recalibrate metrics as required
Lead and participate in FDA and client audits; draft or provide guidance for internal audit reports; contribute towards CAPA closure
Evaluation of Quality Assurance Operations processes to identify opportunities for continuous improvement. Lead and participate in the Continuous Improvement Program
Assess headcount requirements, adjust to business needs and monitor work schedules of staff based on operational activity and long range planning to ensure packaging and compliance requirements are satisfied
Conduct department investigations to determining the root/assignable cause for material and/or process nonconformance. These investigations shall be documented within applicable records. Interface with production personnel to assure appropriate and timely documentation of activities and assisting in resolving issues
Conduct periodic audits of the warehousing and packaging areas to assure that procedures are being followed and areas being maintained in a state of control
A bachelors degree in Science, Engineering, or Pharmacy is preferred and/or a combination of relevant education and experience
8-10 years Quality Assurance experience. Three to five (3 to 5) years managerial experience in a Quality Assurance role in QA/Operations (packaging) is required
Pharmaceutical industry experience (Oral Solid Dose) is required
Experience in auditing and FDA/client inspections
Thorough knowledge of the cGMP requirements
Knowledge / experience in DEA procedures for controlled substances is preferred

Manager QA / Qualified Person QA Compliance Resume Examples & Samples

QP responsibility for the release of Drug Products according to Annex 16 or AMWHV from drug products produced at the site as well as for drug products from external manufacturers
Supervision of the production and testing of TPMs / TPCs (participation in audits, design of quality technical agreements and verification of relevant GMP documents)
QA contact for customers, e.g. contract manufacturing for external customers at Ludwigshafen
Assessment of national and international regulations as well as advising the other departments at local and global level to implement good manufacturing practices
Supervision of global and local projects
Pharmacist with a successfully completed university degree in pharmacy or a person with a university degree recognized according to §15 (1) (2) of the German Drug Code (AMG) and the corresponding proofs according to § 15 Abs.2 AMG
At least two years of practical work in the field of drug product testing to obtain the expertise as a qualified person according to § 14 AMG
Very good knowledge in cGMP (EU, US) and international pharmaceutical legislation
Good knowledge in planning and control of process flows
Knowledge of SAP QM and TLIMS Sample Manager favourable
Knowledge in Lean Six Sigma, project management favourable
Strong analytical thinking and problem solving skills
Independent, team-oriented work style, ability to intercultural cooperation
Negotiable English and good computer skills required

Manager QA, Quality Systems, Commercial Resume Examples & Samples

Manages all aspects of QA Quality Systems for a Phase III/Commercial GMP Viral Therapy/Cell Therapy (VT/CT) contract manufacturing facility
Develops and implements commercial quality systems for the facility including but not limited to Document Control and Recordkeeping, Deviation, Complaint and CAPA systems, Change Control system, Internal and Customer Audit program, Regulatory inspection program, Risk Management program, APR/PQR program for commercial products, Supplier Quality program and GMP Training program
Ensures that Quality Systems for the VT/CT Manufacturing unit meet Lonza Global Quality Standards and applicable regulatory requirements
Manages and plans the work of the Quality Systems group. Writes and/or reviews and approves Quality systems related SOPs
Participates in VT/CT related project teams as required
Meets with clients on a regular basis to ensure that QA systems meet their expectations
Leads, facilitates or participates in Regulatory Inspections and client audits
Ensures Supplier Quality program is in place by coordinating site needs with Lonza Global Supplier Quality team
Ensures GMP training program is in place and maintained for the VT/CT unit
Selects, trains, and supervises staff to perform functions consistent with procedural and business requirements. Develops, mentors, and coaches direct reports as well as coaches other site personnel on Quality Systems use
Assesses implementation and use of site Quality systems on a regular basis and reports metrics to Site Quality Council with proposed actions if required
Leads continuous improvement efforts around the design and use of the site Quality Systems
Participates in cross-site forums and contributes to Lonza Pharma-Biotech (LPB) and Business Unit Quality policies and procedures as requested
Manages or performs other related duties as requested by manager
BA/BS in relative scientific or technical discipline field
Preferred area of study: Science or engineering, biological sciences preferred
Certified Quality Auditor a plus
QA – Quality Systems or Quality Operations in a commercial cGMP environment (obligatory)[Minimum Years of Experience: 5-10]
Management or supervision of QA teams (obligatory) [Minimum Years of Experience: 3+]
Experience managing quality issues related to biologics bulk drug substance and/or drug product manufacturing in a commercial environment. [Minimum Years of Experience: 5+]
Experience managing regulatory inspections [Minimum Years of Experience: 5+]
Working knowledge of global cGMPs related to all aspects of Biologics manufacturing, including ICH Q7 and FDA/EMA regulations related to cell/gene therapy and aseptic manufacturing of drug product
Working knowledge of all Quality Systems required for a biologics manufacturing facility

Manager, QA Operations Resume Examples & Samples

Establishes and monitors the daily production schedules and ensures adherence to priorities
Monitors and identifies procedures set forth in the distribution center to ensure integrity and accuracy of inventory and that available resources are utilized productively in order to control cost
Determines and implements appropriate procedures and monitors adherence to, efficiency and cost effectiveness of the processes, and recommends changes, revisions, additions or deletions as necessary
Monitors activities to ensure proper work flow and controls inventory processes to enhance member experience
Supports all safety programs and OSHA compliance to ensure a safe work environment for all associates
Performs supervisory functions, including but not limited to, making employment decisions regarding hiring, promoting, demoting and terminating, conducting performance appraisals and coaching and developing associates
Coordinates with Receiving, Transportation and DC operations managers to maximize effectiveness in stopping merchandise
Assesses workload demands using Query Master reporting system in conjunction with QA Pending Mandatory reports to establish
Associates Degree or above in Operations Management, Business Administration, Logistics, or Transportation
Working knowledge of Lean Principles

Account Manager, QA Resume Examples & Samples

Responsible for developing specific account and territory strategies while promoting the sale of company products and services within the assigned territory
Working with assay development with major manufacturers, from feasibility to development to commercialization
Specializes in clinical and research laboratories, blood centers, and manufacturers with a strong focus behind building a custom portfolio
Develop OEM custom molecular quality controls for manufacturers in molecular diagnostics, next-generation sequencing, clinical chemistry, and microbiology
Make sales calls, schedule visits to current and prospective clients/customers, effectively manage all stages of sales cycle
Serve as a channel of information to the business unit about customers, markets and competition. Receive guidance concerning markets, prices, products, deliveries and competition from the business unit and sales management
Maintain positive relationships with business unit personnel for service and/or technical support, and client/customer purchasing agents
Attend sales meetings, maintain an outside sales office, and an up-to-date database of clients/customers for opportunity pipeline management, forecasting, and CRM purposes
Must be willing to travel up to 75% of the time
Ability to plan and execute sales activities with minimal direct supervision
Must provide detailed and timely reporting
Effective interpersonal and listening skills, communication skills
Accurate forecasting ability
SalesForce.com experiences a plus
Detail-orientation, analytical approach, strong prioritization skills
Must have highest degree of professionalism and ethics

Test Manager / QA Engineer Resume Examples & Samples

Perform all kinds of tests: regression, integration, system tests
Document defects found during tests using dedicated decect tracking tool
Responsibility for whole QA process
Lead the small testing team and be a local contact to Business Partners
Participate in test planning, execution and R&D activities
Experience in an agile development environment
Mobile application testing
Experience in risk assessment methodologies

Engineering Manager QA Resume Examples & Samples

Experience with storage technologies (NAS protocols – SMB, NFS; file systems, volume management, disk technologies, RAID, SAN, FC/SCSI/iSCSI, snapshots, etc.)
Experience with Linux/UNIX-based systems, including lab and related infrastructure
Familiarity with Networking appliances and tools (switches, routers, Wireshark, Ixia, or Spirent Smartbits)
A minimum of 8 years of experience as an individual contributor and 1 to 5 years as a people manager is required
Demonstrated ability to manage multiple projects is required

Manager QA / QC Lab-ethanol Plant Resume Examples & Samples

Bachelor's degree or higher degree in a related scientific or technical field required
Ten years experience in a QA/QC laboratory required
Experience with implementing effective QA/QC programs required
Experience in a dry-mill ethanol plant preferred
Experience with software programs such as Office, LIMS, SAP preferred
Experience with environmental testing preferred
Experience with local, state, and federal regulators/regulations preferred

Manager, QA Laboratory Resume Examples & Samples

Assist in the development of product specifications, testing to support IND/NDA submissions and study protocols all with appropriate laboratory documentation
Conduct analytical development of new formulations and related assay methodologies
Develop, perform and validate stability indicating assays of sterile product
Identify needs for analytical instrumentation and assists with procurement, qualification and training
Perform laboratory investigations and serve as the SME for functional areas
Manage stability test protocols and perform associated analytical testing. Serve as SME for stability program and annual reporting requirements
Monitor spending for laboratory supplies and labor utilization
Perform and supervise the analytical testing of raw materials, in-process and finished product
Supervise, coach and develop technical staff. Perform performance reviews
Perform laboratory investigations and peer reviews of scientific documentation
Represent QA in regulatory, customer and internal audits
Identify lab test needs for new product development and changes to existing products
Create product trending using analytical release data
Manage chemistry and microbiological staff and testing processes to efficiency meet testing needs to support the Union production needs
Maintain laboratory quality system procedures for compliance with current regulatory requirements and industry practices. Update procedures and processes to ensure compliance, and drive efficiencies

Manager QA Resume Examples & Samples

Manages documentation critical to quality systems, compliance and formulation
Manages internal and external audit/inspection and corrective/preventive action programs
Leads food safety continuous improvement efforts
As part of the operations team, supports other initiatives including Safety, Total Productive Manufacturing, Diversity/Inclusion, Engagement , etc
Leads commercialization process for new products/product formulations
Technical competence in microbiology
Experience with regulatory agencies such as FDA, USDA or State Health Dept
Quality data collection and analysis

Manager, QA Systems & Support Resume Examples & Samples

Responsible for the supervision of the QA Systems and Support team
Via supervision ensure that data integrity is intact and that information in the validated systems, including but not limited to MyCIMS, TrackWise is correct and readily available at time of use
Maintain quality systems based on current GMP, Good Documentation Practice and regulatory requirements and assure product compliance through quality systems
Coordinate preparations of site inspections and partner audits and ensure site master file is kept up to date
LI-POT2
A solid background and extensive experience working in the pharmaceutical/biotech /medical device industry
Proven track record as a successful leader of diverse teams

Manager, QA Continuous Improvement Resume Examples & Samples

Scientific degree
5 years of experience in pharmaceutical job or lean culture activities
Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style and well developed relation building skills to gain trust and credibility and to build a great place to work and good social climate within cross functional (project) teams
Excellent team builder / team player
Operational Excellence (Lean Six Sigma certification) and/or Project Management Certification
Customer orientation : ability to active listening to internal customers and pro-actively proposing solutions based on their needs
Analytical and problem solving (trouble shooting) skills - creative approach to problem solving and the ability to challenge the status quo
Effective communication skills, including training / animation / presentation skills
Effective influencing skills – ability to influence at all levels of management and to energize a team towards to pursue common goals
Sense of urgency, flexibility and accountability
Enterprise thinking (end-to-end supply orientation, cross functional team spirit, sharing of good practices within the network)
Proven Planning & Organizational skills
Coordination of the FDA commitment at a BU level
Coordination of the Facility Improvement Project (FIP))
SPOC for the Validation Manager regarding coordination of the continuous validation plan (CVP) at a

Manager QA Validation Resume Examples & Samples

Designs and develops policies related to validation and ensures that they are effectively administered and comply with regulatory requirements
Responsible for all aspects of QA Validation including review and approval of the following types of documents, relating to area functions
Change controls and associated Test Plan documentation
SOPs
Validation Master Plans
Interviews, hires, orient, and trains incoming personnel
Manages Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks
Develops and manages validation budget, contracts, and schedules
Presents/defends validation data to FDA and other regulatory agencies
Maintains validation document and software control system
Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing
Organizes QA Validation resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management
Plays a proactive role in developing and applying new approaches and processes to validation strategies
Regularly interacts with senior managers and executives to create a broad-based validation program
Applies complete functional knowledge and awareness of company goals and objectives
Counsels employees about work performance; conducts hiring and discharge interviews
Requires BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes
Level will be determined based on skills and related experience*

Junior Online Project Manager, QA / UAT Resume Examples & Samples

Support EU program managers on changes, enhancements and releases for three markets (German, France, and Italy)
Coordinate localization requests with markets, and ensure proper and timely delivery and implementation of translations across web, mobile, and apps
Validate changes and drive improvements identified through this validation
Raise tickets for changes as well as bugs and actively follow up for closure
Support creating and deploying local landing and campaign pages together with the local marketing teams
Support QA manager with UAT testing of changes, enhancements, and releases for three markets
Responsible for test devices readiness. Ensure devices are up to date, charged and clean for testing

Asst Manager, QA Resume Examples & Samples

Lead QA Activities for all initiatives across multiple projects in an Agile environment
Champion the development of a comprehensive functional, automation and performance test strategy
Ensure adherence to Testing Governance and oversee the quality of deliverables from India team members and coordinate with US team
Produce Quality Dashboards which highlight the quality of the current release and provide predictability for production readiness
Be an advocate for Quality Assurance best practices across the entire SDLC, not just within the Testing/QA phase
Pro-actively facilitate continuous improvement in all areas of the SDLC from continuous integration, agile adherence, estimating and tracking of artifacts to execution of test process through Dev, QA and Production phases
BE/BS Computer Science or Computer Engineering with good consistent academic record, MS preferred
Minimum 10+ years of overall QA experience and 2 years of management experience in software quality with on-site and off-shore QA teams
Strong experience on different software development lifecycles and methodologies, e.g. Waterfall, Agile, etc
Strong experience with the development of automated testing in addition to manual testing
Strong experience with performance testing
Fluency in SQA/SQC methodologies and HP Quality Center, Protractor, SOAP UI tools
Web testing experience is required
Understanding of relational database systems, and their interaction with application components
Ability to handle multiple projects and tasks concurrently
Strong ability to manage multiple and sometimes competing priorities
Excellent verbal, written, analytical, and time-management skills
Strong critical thinking and analytical skills and ability to think “out of the box” required
Demonstrated ability to work effectively in a fast-paced, challenging team environment

Project Manager QA Resume Examples & Samples

Should have knowledge of different kinds of testing like Systems Testing, Integration Testing and UAT
The resource will have responsibility to understanding the project functionality, build test strategy, track test cases and issues and take them to closure as part of the project deliverable
Candidate to be trained in Oracle Applications and preferably in Opportunity to Cash areas
Knowledge of Oracle applications/technology
Knowledge of Cloud
Knowledge of Jira
Computer engineering degree
Functional Knowledge about Opportunity-to-Cash flow

Manager, QA-clinical CMO Oversight Resume Examples & Samples

Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met
Implements and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
Works extensively with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications
Serves as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. May lead compliance audits as required
May interface with regulatory agencies as required
Demonstrates in-depth knowledge of GMPs and/or GLPs
Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements
Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred
Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred
Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred
Bachelor’s degree in the sciences (e.g. biology, chemistry, analytical or bio-analytical chemistry, engineering) with a minimum of 8 years of pharmaceutical experience in a GMP quality (QA/QC) environment. An advanced degree in sciences would be a plus
Strong experience in leading and managing regulatory inspections
Strong experience with leading and managing quality investigations and Materials Review Board
Strong working knowledge of cGMPs (US, Canada, and Europe) requirements as applicable to both drug products (solid oral dosage forms, parenteral and inhalation products)
Experience in writing and reviewing Quality Agreements with contract manufacturers
Strong auditing experience on contract manufacturing organizations. Certified Quality Auditor would be a plus
Able to travel for 10 – 15% of time is required

Manager, QA & Process, Construction Chemicals Resume Examples & Samples

Technical Training on chemical analysis/ QA
Manage to analysis competitors’ products to compare the strength/weakness to improve our products or to make sales tool for sales activities
Control inspection and define standards / Create and set quality control production programs/quality standard and co-operate with production function to insure that all raw materials and finished products are inspected and tested in accordance with the established systems and approached to ensure they always and consistently meet quality standards and specifications. Discuss plant evaluation with plant management, made appropriate recommendations and set timetable for improvement and corrections. Function as an information source for the products and raw materials for production when critical quality issues arise
Develop and maintain operation manual / Responsible for the edition and periodical update when necessary of the Quality Control Manual in order to formulate the accurate guidelines for all relevant staff e.g. engineers, operators, etc
Customer complaint handling / Be responsible for final evaluations of serious inquiries or customer complaints on sub-standard products in order to find best resolutions and maintain good company image. Meet with vendors, suppliers, quality representatives, etc. to make certain the company’s QC programs stay up-to-date and in step with current market standards
Quality control / Confirm that plant quality control procedures are properly carried out. Act as final checkpoint to determine overall company products and materials quality and advice immediately the plant management any unusual findings and recommend corrective actions. Educate and instruct production personnel in recommended quality control testing, equipment sanitation and general sanitation and housekeeping practices. Prepare monthly plant evaluation reports and submit to the heads of plant and production
ISO administration / Plan and direct activities related to ISO certification in order to secure the certification and successfully pass the subsequent audits
People and function management / Plan and control the function structure and manpower requirements, headcount and budget, establish development measures and appraise the performance of the team. Direct and prioritize the workload of team members. Train (via on-the-job, in-house and/or external training programs) and coach the direct reports (who are mostly experienced professionals/ managers) and develop the succession planning in order to improve the working efficiency, quality and professional skills of the team members. Compile and review work records to determine department productivity, quality of output and cost of service. Develop methods to continually improve results
Budgeting and cost controlling / Evaluate and develop function annual budgets and administer funds according to budget approval. Provide information to management regarding the budget for equipment, software and hardware purchases/installation and maintenance. Consolidate the expenditures of the office/site to draft the annual budget requirements of new financial year to define the new capital and working expenses for office equipment and furnishings according to establish policies and procedures. Control the reasonable use of the expenditure according to agreed standards and regulations, including approval of pretty cash and invoices up to 5 mio. JPY for each transaction respectively. Safety and housekeeping / According to corporate, company and statutory EHS requirements, implement the relevant safety and environment protection policies and procedures by seeking consultation from with EHS Manager, including enforcing the observation of all company’s operations, safety, ecology and housekeeping guidelines to maintain a working environment that supports work safety and production activities. Execution of EHS measures into QA group. In operation organization, RC code 1 and 5 is under responsibility in TDC

Manager, QA Resume Examples & Samples

Participate in planning and development of quality controls
Part of the extended project team to plan ahead QC and QA needs
Produce analysis and reports in connection with the testing team (standard QA reports, test plans, test cases, team productivity, etc.)
Standardize and document QA processes
Accountable to communicate product quality level before any external delivery and stop delivery if quality standards are not met
Be responsible of the performance and career management of its direct reports
Elaborate, maintain and communicate resource plan to manage / align / utilize skillset and workload using the company defined tool like JIRA
Motivate the team to contribute to GEE and operation vision
Coach and mentor the team leads to foster an effective and mature team
Onboard and train new staff on best practices and uses internal tools
Coordinate with the different teams worldwide , manage expectations and deliver to them
B.E/MCA/PG in Computers
Testing course from a reputed institute
Minimum 5 + years of experience in mobile application testing on Android and iOS platform
Minimum 3 + years of experience in web application testing
2 -3 years of experience in automation tool like Monkey Talk or Selenium and scripting language e.g Python
Team management experience
Experience working in Agile teams
Experience with Back and Gray-box testing
Fluent in English, written and spoken

Manager QA Resume Examples & Samples

Strong organizational skills, including ability to follow assignments through to completion
Six Sigma and/or Lean Manufacturing Certifications, Continuous Improvement Tools
Collaborate and communicate with higher level outside resources
Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation, and process development
Strong communication (both written and oral), facilitation, and presentation skills
Ability to lead and influence staff outside own organization
Ability to motivate staff and manage and distribute workloads
Able to manage performance issues and conflict
Ability to provide direction and establish goals for individual staff members and work group
Ability to evaluate documentation/ operations according to company and regulatory guidelines
Ability to interact with regulatory agencies

Associate Manager, QA Product Quality Resume Examples & Samples

Administers effective, accurate, and timely communication across functional areas, Regeneron locations, and corporate partners, serving as a primary point of contact for QA-related activities
Serves as Quality Assurance liaison for business relationships
Communicates notification of change controls and deviations to global functional areas and business partners
Utilizes tools and mechanisms to ensure global alignment of processes, procedures and methods
Applies complete understanding of principles, concepts, techniques and standards
Acts as a single point of contact for consistent product quality oversight and to maintain product knowledge while helping project teams achieve their goals
Functions as a QA lead on CMC project teams in order to facilitate advancement of product development through the pipeline. Projects are generally, but not exclusively, moderate to advanced complexity. Coordinates cross-functional QA activities to meet objectives as a liaison between project teams and other quality functions. Communicates quality resources needed to align with the overall product timeline and goals
Provides support to technical transfer teams to effectively manage the development QA activities with the CMO or partner
Coordinates critical/major investigations exercising judgment to engage the associated quality function and upper management appropriately
Assists as needed in audits and inspections
Becomes involved as required to meet schedules and resolve problems, having the broad knowledge to deep dive into issues when quality guidance is required
Acquires product-quality knowledge and product-quality history throughout the development cycle
Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations
Involved in daily operational activities
May lead a team of Product Quality professionals as the group evolves
Full knowledge of quality and cGMP principles and systems and relevant regulatory guidelines
Competency in influencing, negotiating, problem-solving, analytical thinking, decision-making, collaborating, and organizing
Ability to resolve conflict with tact and diplomacy
Working knowledge of Microsoft Project and SharePoint is a plus
Language skills in French and German also a plus
Requires a minimum BA/BS degree with 6-8 years of industry/relevant experience or MS with 3-5 years
PMP certified a plus

Senior Program Manager, QA Resume Examples & Samples

Facilitation & Technical Lead for the analysis of consumer trends and data, consumer complaint programs,outline comprehensive plans to improve Consumer Satisfaction
Provide insight and support in the development, implementation and ongoing tracking of appropriate Quality performance KPI’s
Influence management to ensure alignment of quality strategies, annual objectives, and project plans

Manager QA, ADC China Affiliate Resume Examples & Samples

Act as Authorized QA representative for ADC China
Maintenance of the quality system to meet the requirements of ISO 9001 and ISO 13485
Implementation of affiliate related divisional quality procedures and local procedures. Create / revise local procedures as required
Conduct internal audits. Prepare teams for global audits
Primary contact for external auditors and government inspectors on-site
Coordinate Management Review meetings
Primary contact in the country for all Quality related matters
Supports management to ensure effective operation of the business while maintaining compliance with policies, procedures and legal and regulatory requirements
Ensure appropriate training plans, and timely completion of training for ADC Affiliate employees
Handling of customer requests regarding quality related issues
Interaction with the customer service and the vigilance group with regard to potential reportable events, medical events and field actions. Responsible for reporting Field Actions, recalls and Medical Events to authorized agency
Translation approval of technical documentation
Proofreading of product labeling with respect to country specific requirements
Ensure compliance of contracted warehouses and distributors with China regulations and Abbott policies and procedures
Create CAPAs in response to an audit observation or nonconformance. Ensure timely completion and effectiveness of corrective actions
Qualification and approval of local suppliers and service providers. Maintain Approved Supplier list

Technical Program Manager QA, Building Resume Examples & Samples

Collecting business and systems requirements from internal and external customers
Writing specifications, driving project schedules from design to release, and managing the production launch
Lead and coordinate Quality Assurance efforts between internal teams and outside merchants and vendors to develop optimal solutions
Make appropriate tradeoffs to optimize time-to-market, clearly communicate goals, roles, responsibilities, and desired outcomes to internal cross-functional and remote project teams
Develop and drive high-level strategic initiatives, but also roll up your sleeves, dig in and get the job done
Anticipate bottlenecks, provide escalation management, and balance the business needs versus technical constraints
5+ years of relevant experience in program management
Knowledgeable in the practical application of program management principles and tools
Experience working with ODM as well as JDM development models
Ability to take projects and break them down into pieces, develop specifications, then deliver them in a manner
Experience managing efforts in quality assurance and system level testing
Experience in delivery and commercialization in consumer electronics
Detail-oriented with a demonstrated ability to self-motivate and follow through on projects

Assoc Manager QA Validation Compliance Resume Examples & Samples

Develop, manage and lead the site QA Validation Operations Compliance Team
Develop Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices
Development of processes and systems that drive compliance to critical regulatory requirements
Development and deployment of Validation specific training
Manage all aspects of QA Validation Quality & Compliance
Influence the development and revision of local and global policies, standards, procedures and business processes in alignment with industry standards and best practices for Validation
Promotes a GxP and Quality mindset at all levels
Work with the Site Head of Validation and cross site validation team to ensure appropriate execution of validation strategies and compliance with internal procedures
Ensures that all quality based deliverables are complying with regulatory and quality policies and procedures and timelines are met and observations are corrected
Assesses company's Validation Programs and identifies any potential gaps
Provide input to complex investigations
Keeps current on changes to all regulatory requirements and, with other members of the Quality team, facilitates implementation into Regeneron systems
Participates in regulatory audits and communicates company's validation policies
Coaches, develops and mentors direct reports
Manage relationships, identify compliance issues and execute resolution in a highly autonomous manner
Requires a BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 6+ years of related experience within the field; may consider substiting relevant experience for education
Experience leading, supervising, or managing others required
Quality and/or Validation experience essential

Manager, QA & Testing for AML Resume Examples & Samples

Identify, test, and evaluate key control points
Validate the work of QA Analysts to ensure sampling results are comprehensive, including sampling of Onboarding activities and FIU investigative decisions, and accurately identify BSA/AML risk factors
Develop meaningful, robust metrics and reporting of findings and progress against remediation objectives to management and other key stakeholders
Work with U.S. AML/ATF personnel and business line representatives to assist in the development of training, where appropriate, based on corrective actions
Promote a risk-aware culture; ensure efficient and effective risk and compliance management practices by adhering to required standards and processes
Monitor the regulatory environment for emerging legislation and policy statements. Keep abreast of trends and industry best practices through review of regulations and guidance issued by various regulatory agencies, publications, participation in industry associations, and work with other members of U.S. AML/ATF

Manager, QA IT Quality Resume Examples & Samples

Serve as a technical Quality Assurance Subject Matter Expert supporting change controls, deviations, internal and external audits and other verticals to ensure a robust, compliant state of programs
Engage with both Corporate IT and IOPS IT to ensure IT processes and procedures meet Regeneron’s Quality System requirements
Provide ongoing support to the Quality Auditing function with respect to IT vendors and audits
Engage cross-functionally to define and implement process improvements, gap-analyses and data integrity initiatives in the computerized system space
Partner with departmental leaders to ensure a consistent, reliable process for the quality compliance of IT systems
Review and provide quality oversight (as needed) of IT related change controls, deviations, CAPAs and data integrity initiatives
Engage with other QA leaders to ensure robust and consistent, quality-driven processes are developed to support a global IOPS division
Provide leadership and tactical support for regulatory, partner and internal audits for the QA IT Quality organization
Knowledge of 21CFR11 and Annex 11 as well MHRA, FDA and WHO data integrity guidelines
Knowledge and experience with Computer Systems Validation and/or IT Auditing
Understanding of the interdepencies of change management, deviation and continuous improvement. Ability to define a vision and implement interim milestones
Knowledge of global organizations, process mapping and process improvement

Manager, QA & UAT Resume Examples & Samples

UAT Scope, Strategy, Design, Planning, & Scheduling (cover end-to-end and departmental needs)
UAT Resource Planning (work with departmental heads to secure availability of UAT testers)
UAT Environment Readiness (cross functionally work with Business & IT)
UAT Test Data Readiness (work with test data set up, configurations teams)
UAT Execution (work with UAT testers to efficiently execute UAT, log issues, and resolve with IT)
UAT Progress Reporting (weekly reports to senior execs; be in sync with PMO on project schedules)
Root-causing high priority, high impact UAT defects (with a cross-functional team)
Developing action plans to address UAT defect root causes to avoid recurrence (with Business & IT)

Manager, QA Resume Examples & Samples

Degree in Engineering (Mechanical or Electronics) or Degree in Sciences
5 years of working in a Quality Assurance function with managerial experience
Relevant working experience in ISO13485 and GMP environment preferred

Manager, QA Engineering Resume Examples & Samples

Develop resource strategies, allocating staff, tools and specialized support as necessary to ensure that all testing commitments are met
Mentor, guide, and coach other QA team members in order to make sure they are successful individually and as a team
Review, evaluate, plan and improve existing and future QA tools, processes, methodologies, and resources
Develop and improve QA best practices
Ensure delivery of the best quality products

Manager, QA & Testing, Mobile Resume Examples & Samples

Manage day to day activities of the quality engineering team in a fast paced agile software development environment
Manages SDLC including test driven development, testing, code promotion and production support
Manages all deliverables to ensure adherence to deadlines, specifications, and budgets
Implements performance metrics and prepares periodic reports. Monitors and tracks project progress and reports findings to leadership team
Manage & maintain test automation frameworks
Provide guidance to Engineering team and other departments in identifying product and technical requirements. Serve as primary point of testing contact and liaison between Technology, Product and operations
Strong hands-on technical expertise
Ability to handle multiple, competing deliverables in a fast paced agile environment
Exceptional Customer relationship skills including the ability to detect and solve complex business problems
Recommend alternative technical & business solutions and lead quality engineering efforts to meet aggressive schedules

Manager QA RTC Resume Examples & Samples

At least 5 years of experience in a similar role or in QC function or production function within a pharmaceutical / biotech / medical device / food industry or equivalent environment
Direct experience with GxP regulated environment within a major jurisdiction
Proven experience in Quality Assurance, not necessarily within a quality department, and strong knowledge of cGMP (for biological products) and regulatory guidelines
Experience in QA release and leading people (e.g. via project management experience)
Experience with clean or aseptic manufacturing is an asset for certain manufacturing units
Manages technical / release problems, evaluates potential impact on product quality and ensures timely escalation of issues
Assure the management of complaints and assures the management of product recalls? (Primary contact for any release related issues for GSK clients including health authorities (EMEA, FDA, AFFSAPS, PEI, SWISS MEDIC, ISP, MoHs..) and non profit organizations (WHO, UNICEF…)
Ensures inter-MPU back up in the area of responsibility as required
Trending
Performs trend analysis on different quality systems to support QA Operations to further improve the systems and results
Contributes to Inter MPU meetings to share and review trending results as to foster continuous improvement and manage risks
Contributes to the quality strategy and the preparation of the Quality Plan for the MPU, prepares dashboards to communicate performance against objectives
Ensures compliance of MPU processes with cCMP's and GSK Vaccines Belgium Quality Management System
Ensures Documentation Management within the MPU is aligned with GSK Vaccines Belgium Documentation system / SOPs and performs compliance check as well as alignment with method of production, process validation and regulatory files prior to procedure approval ; ensures all MPU master production documentation is in line with validation and regulatory files prior to QA Operation approval
Approves MPU specific GMP training packages for QA, Production and support staff within the MPU and ensures QA staff are adequately trained/certified and coach QA team through presence on the shop floor
Approves MPU static master data
Approves specific MPU compliance and quality risks and follows up risk register actions
Timely escalates critical non compliance and compliance/quality risks within the MPU to management and manages these risks through the risk register process
Ensures all changes implemented within the MPU are aligned with GSK Vaccines Belgium change control procedures and regulatory requirements (MPU change control approvals)
Organizes and coordinates MPU preparation for L3, L4 and RIMP inspections, applies inspection readiness program for the MPU
Prepares internal L2 audit and L1 self inspection programs for the MPU and ensures they are performed according to schedule
Organizes and takes the Quality Assurance responsibility for new projects (facilities – utilities – equipment – processes) in the MPU
Ensures MPU regulatory files are adequately reviewed before submisson
Maintains knowledge and experience up to date in the light of technical and scientific progress and changes in quality management
People Management & Development
Leads, selects, trains, evaluates, coaches and motivates team towards the pursuit of excellence and attainment of Good Manufacturing Practices
Ensures optimal staffing levels and competencies are in place and ensures the retention, engagement and development of talent within the organization
Manages people through effective performance management and labour relations excellence
As a leader, personally role models and develops the team towards high performance behaviours
Engages the team to deliver the GSK Vaccines, GIO and Quality strategy
Budget
Not applicable
Health, Security, Environment
Is responsible for the compliance with all applicable standards and policies
Change and continuous improvement
Shares and integrates best practices within the GSK Quality, GSK Vaccines and wider GSK Network
Representation
Represents quality during external regulatory audits in specific area of responsibility

Manager, QA Compliance Resume Examples & Samples

Provide leadership and oversight for the Quality Systems Department to ensure the attainment of corporate and local objectives,
Responsible for the monitoring of FPG’s deviation, CAPA and CC system for on-time closure. Holds routine follow-up meetings and escalates issues to Sr. Management. Performs QA review/approval of these, as needed
Leads Quality Review Board reporting and monitoring for local GXP compliance to established metrics
Ensures adequate actions are taken in response to quality issues and follow-up for their effectiveness. Identifies areas for improvement and modifies QRB process, where necessary
Reviews and approves documents as required, including protocols, reports, document changes, etc
Assures that SOPs related to QA are updated,Ensures company and departmental document management and training system (including GMP and GCP programs) are established and maintained to support regulatory and Company requirements,
Coordinates activities and supports interactions during regulatory agency inspections and corporate audits. Provides oversight of audit conduct and reporting, including allocation of appropriate audit resources,
Coordinates activities and leads the Annual Product Review/Product Quality Review process for FUS QA. Provides the required information to effectively prepare and approved the APR/PQR by the required due dates
Monitor and assess emerging Quality and Regulatory requirements/issues and determine impact to the organization,
Other projects as assigned by the Director, Quality Systems

Manager QA Resume Examples & Samples

Effectively implements Quality System strategy defined by WW Quality System, BQ standard & Compliance and Drugs and Cosmetics Act
Possesses a thorough familiarity with the requirements applicable under Drugs & Cosmetics Act & ISO 13485/ISO 9001 & ensure established system remains in compliance
Ensures that the Quality System is regularly audited / reviewed and that changes needed are implemented in a timely manner
Ensures all stakeholders are trained on the quality & regulatory requirements
Ensures periodic review/inputs of Quality Agreements and Change controls (as applicable)
Maintains an effective Quality Information System (Doc Management, Compliance Wire, ETS Trackwise, etc.)
Actively participates and contributes in periodic Management Review meetings
Review and act as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, fact books, and non-conformances & CAPA
Takes appropriate actions to create and maintain a working environment aligned with J&J’s CREDO
Oversees quality assurance auditing of service providers and systems (Supplier audit and Internal Audit)
Support Quality Operation (warehousing operations, 3PL management, audits, distributor management practices etc.) and collaborate with CLS quality
Support Quality Improvement Processes, Affirmative Action objectives and all activities to achieve Various Quality Objectives
Participates / Owns the execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner
Escalate all significant quality issues as and when made aware of
Master’s degree in Science / Bio Medical Engineering
8 to 10 years of experience in Quality Assurance , Quality Control in Medical Device / Pharma Industry
Around five (5) years in supervisory role
Regulatory compliance Knowledge and skills…preferred
Advanced Quality System Knowledge
Interpretation and application of Drugs & Cosmetics Act, QSR and ISO Standards
Excellent communication and interpersonal relation skills
Statistical and analytical problem solving
Advanced computer and use of software applications

Manager, QA & Release Mgmt Resume Examples & Samples

Oversees the implementation and management of the release process for code through development, test, and production environments
Develops and implements business plans, policies, and procedures associated with building, deploying, and updating software and environments
Manages the IT Release Calendar and coordinates team on IT releases
Directs efforts in defining the IT strategic direction for release management tools for IT to ensure the process requirements of release management are built in
Partners with project team to ensure milestones adherence to certify integrity of the release can be measured. Evaluates results within business unit to determine if organizational objectives are being met
Works with 3rd party service providers, project and solutions delivery teams to ensure quality plans address the risks associated with implementing a solution
Will provide governance around the managing of quality test plans and validating the organizationally we are supporting quality assurance best practices

Manager QA Operations Resume Examples & Samples

Manage the QA batch review and validation department of ADD Site Operation Wiesbaden
Provide Quality support for execution of validation/qualification and batch release activities according to schedule and priorities
Maintain site validation masterplans activities and allocate resources as needed for projects according to priorities
Ensures completeness and maintenance of Device History Record
Act as Subject Matter Expert for the Validation and Calibration Subsystem on site level and align with other manufacturing sites and global standards
Establish and maintain performance metrics and tracking systems for management updates
Continuous consideration of process improvements and implementation
Ensures support of product and cost improvements, new product launches and transfers
Priority and Resource Management
Plans and manages budget and resources
Identifies and elevates potential quality issues
Presentation to internal and external customers
Representative for internal and external audits

Associate Manager QA Validation Resume Examples & Samples

Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices
Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required. Execution of validation projects and overseeing Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, executing validation protocols and writing reports of validation results
Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides guidance to Validation staff writing protocols and final reports
Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements
Approves various documents relating to area function, including those listed above
Provide direction and assign work to Validations Specialists to meet goals and timings
Coordinates prioritization of activities with area management
Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality
Ability to maintain integrity and honesty at all times
Continuously drive to improve processes for improved performance
Ability to lead and be accountable for team’s performance and results
Develop strategy and create metrics to measure effectiveness of strategy
Lead through ambiguity and translate into actionable steps
Ability to problem solve and identify root cause
Ability to build, lead, and motivate team
Requires a BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 6+ years of related experience within the field with 2 years managing direct reports or 8+ years of related experience within the field. May consider substiting relevant experience for education. Experience leading, supervising, or managing others required

Senior Program Manager QA Engineering Tools Resume Examples & Samples

Develop Vision & Roadmaps - Help define clear and concise focus areas by identifying the
Streamline Processes – Identify and document best practices that our teams rely on to release with the highest quality and on schedule. Ensure the best agile practices are being applied to the software development cycle. Champion continuous improvements to maximize process efficiency and effectiveness
Own Schedules – Develop schedules and own all commitments and operational plans. Anticipate and make tradeoffs to balance the business needs versus technical constraints
Provide visibility - Communicate project status and roadmap to varied audiences. Train employees/create new operational procedures

Manager QA Resume Examples & Samples

Provides inspection readiness support to EPD locations, as applicable, through the identification of compliance gaps and risks, and participation in the remediation process
Provides on-site support during regulatory inspection, as applicable, as Front or Back Room resource and Division scribe
Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close
Reads and extracts developing regulations and trends from available sources to provide recent perspectives during audits. Ensure a proactive determination of regulatory, compliance and quality issues and integrates them into audits/assessments on a priority basis
Responsible for communication and documentation of internal and external compliance related information. Includes changes in regulations, new guidelines and guidance documents from regulatory authorities and trade organizations
Manages assigned global quality projects and compliance initiatives
Takes lead on assigned cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, or Engineering
Minimum of 7 years of related work experience in the Quality area is a must
Experience in the manufacturing environment of a regulated industry is a must
Experience with government and corporate audits is a must
Experience in supervision and project management at a global (multi function and multi country) level
MS Office proficient
Excellent communication skills both in english and spanish

Assoc Manager QA Resume Examples & Samples

Responsible for all aspects of QA Team including review and approval of the following types of documents, relating to area functions
Master records
Validation protocols and summary reports
Performs compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions
BS in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with minimum 6 years of experience in pharmaceutical or biologics manufacturing environment. Relevant experience may be considered in lieu of the educational requirement
Supervisory and/or leadership experience essential

Manager QA Raw Material Resume Examples & Samples

Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area; supporting workforce diversity, quality and safety and supporting supervisors in the management of their employees/department which support achievement of individual/department/business objectives
Lead a functional group and release incoming/raw materials with the following requirements
8 years of experience in the pharmaceutical or related industry or an equivalent combination of education and experience
3+ years of managerial or supervisory experience
3+ years of experience in a Quality Assurance environment in the biopharmaceutical or biotechnology industry with knowledge of raw materials and associated test records
Accountable for batch release and the associated quality decisions
Makes decisions based upon the assessment of information from many sources including vendor processes, QC testing, and various customer requirements
Makes decisions about the safety and efficacy of materials for release
Executes QA activities within the constraints imposed by broad company policy and government regulations
Broad cGMP experience and knowledge
Skill in evaluating multiple discrepancy investigations for cause/correlation and impact to overall material and process quality
Experience in material release standards for the US, EU, JP and other primary regulatory markets
Demonstrated ability to lead cross functional teams
Ability to create and deliver training materials about complex systems and processes

Manager, QA & Appeals Resume Examples & Samples

Manage daily workflow to meet service levels, including making recommendations for maintaining appropriate staffing levels
Ensure execution of day to day quality assurance testing at agreed upon sample levels
Build relationships across the organization to support communications of quality testing outcomes and trends
Create and deliver operational reporting
Escalate claim-specific and process-wide issues as needed
Compile and analyze quality/appeal data to identify learning opportunities or trends requiring intervention or determination of root cause
Make recommendations to business partners for systems enhancements, training needs, and overall process improvements
Ensure that claim appeal practices meet all state and federal regulations
Provide QA and Appeal staff with coaching, direction, leadership, support, feedback and development opportunities in order to achieve company, department and employee development goals
Set clear expectations and hold staff accountable to reach goals
Conduct and ensure performance reviews are handled timely
Challenge and inspire employees to achieve business results and motivating them through leadership
Participate in ad-hoc audits, duties, projects and initiatives as assigned

Manager, QA Validation Resume Examples & Samples

Responsible for the management and work assignment for the QA Validation Computer Systems Validation personnel at Rensselaer IOPS site
Mentor, develop and support the QA Validation Review personnel
Engage with the various IT teams to ensure that all GxP computerized systems are validated for intended use and fit for purpose
Lead FTEs and consultant-based resources responsible for the development and execution of computer system validation projects
Develop and report out metrics and other KPIs to examine and ensure the health of the CSV program
Provide leadership and tactical support for regulatory, partner and internal audits for the QA Validation organization
Detailed knowledge of GAMP, 21CFR11 and Annex 11 required
Familiarity with MHRA, WHO and FDA/EMA guidelines for data integrity required
Knowledge of software development lifecycle required. Experience with Software as a Service (SaaS), Infrastructure as a Service (IaaS) and/or Platform as a Service (PaaS) is desirable
Ability to work in a dynamic organization where innovative solutions are required to ensure a high-level of quality is achieved with aggressive timelines
Provide leadership to direct and indirect reports
Coaching and conflict resolution

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