1+ months

Senior Quality Assurance Specialist

Kelly Services
Sunnyvale, CA 94086
**Senior QA Specialist**

Kelly Science is seeking a contract Quality Assurance Senior Specialist for a global biotechnology company. The Sunnyvale facility strives to find solutions to both the technical and conceptual barriers to enable development of cell and gene therapy approaches for the treatment of human disease. As a member of the Quality team, candidate will have the opportunity to ensure that all aspects of the operational business for the Sunnyvale sites clinical and commercial pipelines comply with cGMP.

**Primary Responsibilities:**

+ Provide Quality oversight and approval of deviation, CAPA, and change control records for cell therapy products, ensuring records are properly initiated, investigated and resolved in accordance with established timelines.

+ Lead production record review, lot disposition and provide GMP guidance to Manufacturing, QC, Engineering/Facilities.

+ Responsible for developing and maintaining processes and procedures to ensure appropriate quality oversight while demonstrating compliance with cGMP.

+ Coordinate release of final cell-based therapeutic products for clinical applications.


+ B.S. degree in a scientific or related discipline and a minimum of 5 years progressive experience in Quality Assurance in a cGMP environment; or equivalent combination of education and experience.

+ Must have experience in aseptic processing, cell therapy, and FDA inspections.

+ Strong knowledge of US and EU pharmaceutical GMPs.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

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.
Posted: 2020-07-27 Expires: 2020-10-01

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Senior Quality Assurance Specialist

Kelly Services
Sunnyvale, CA 94086

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