Kelly Services is currently recruiting for Quality Assurance Specialist for our client, a multinational pharmaceutical and biopharmaceutical company.
If this position may be interested to you, please email me back at firstname.lastname@example.org (with your most up to date resume in word format) and advise the best time and number at which you can be reached.
Job Title: Quality Assurance Specialist
Location: Cambridge, MA (Position will start from working from home and eventually transition back to office in Cambridge) (Will be onsite 1 hr/week during COVID)
Type: Contract (W2)
Length: Indefinite (long term)
Pay Rate – $65 - $78 per hour
Candidate must be eligible for direct W2 contract without employment sponsorship.
Notes from the hiring manager
- Quality, R&D role, GxP systems
- Quality oversight needed
- Global systems support
- Software development lifecycle knowledge helpful
- Working in Agile environment
- Infrastructure qualifications, systems validation and implementation knowledge
- Lab equipment oversight, computerized systems overview
- Not a validation lead role, but validation experience very helpful
- Will be onsite 1 hr/week during COVID
Under the direction of the Head, Data Systems, R&D Quality Assurance and Compliance, this role is responsible for providing support in software quality assurance overseeing of systems validation activities related to systems utilized by the Research & Development team. You will provide compliance leadership and direction to business and project teams in Software Development Life Cycle / System Validation (CSV)/Lab Systems/Lab Equipment/Infrastructure Qualification standards and practices.
This is accomplished by:
- Providing professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners.
- Participating in the delivery of system solutions by overseeing/reviewing SDLC/CSV/Qualification activities.
- Guiding development of validation/qualification/migration/verification strategies for software (including lab), data, mobility, hardware, infrastructure/components and/or business processes prior to release into a live environment per company procedure(s).
- Overseeing execution of validation/qualification/verification/migration strategies per company procedure(s).
- Providing validation/verification/qualification guidance to stake holders as necessary.
- Managing relationships with key customers and stake holders to ensure oversight that the total validated/verified/qualified solution delivered meets/exceeds expectations.
- Ensuring SDLC/CSV/Qualification activities are conducted in a compliant and timely manner.
- Subject Matter Expert on SDLC/Qualification procedures and regulations and able to provide guidance to IT and/or Business.
- Participate on cross functional teams to oversee validation/verification, implementation, and maintain regulated (Example: GxP, JSOX etc.) systems across the Organization.
- Oversee the validation/verification/qualification strategy development by working with the validation team.
- Work with project team's offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
- Ensure the project testing scope is met per specified agreement and/or scope change.
- Understands the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.
- Bachelor's Degree in Life Science or Computer Science
- Minimum 10 years of software quality assurance experience with lead experience.
- Broad knowledge of software development life cycle.
- Must have pharmaceutical industry experience and familiar with GxP.
- Demonstrated experience leading cross functional teams advising on compliance related matters and influencing Senior Leaders.
- Possess the following qualifications is added advantage:
- American Society for Quality (ASQ)
- Certified Software Quality Engineer (CSQE)
- Quality Assurance Institute (QAI)
- Ability to fly to travel regionally and globally for meeting if required.
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Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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