10 days old

Quality Assurance Specialist: Day and Swing shifts available (San Jose, CA)

Kelly Services
San Jose, CA 95115
Quality Assurance Specialist

San Jose, CA

6 month contract

40 Hours a week

Monday Friday 8 am 5 pm or 1 pm 9:30 pm with flexibility for OT from time to time

(2) Day and (2) Swing openings

Your Tasks: As a member of the Quality team, you will have the opportunity to ensure that all aspects of the operational business for the Sunnyvale site s clinical and commercial pipelines comply with cGMP. You will be responsible for providing 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. You will lead production record review, lot disposition and provide GMP guidance to Manufacturing, QC, Engineering/Facilities. Furthermore, you will be responsible for developing and maintaining processes and procedures to ensure appropriate quality oversight while demonstrating compliance with cGMP. The unique duties of this position will consist of coordinating release for final cell-based therapeutic products for clinical applications. Overall, your leadership ability and deep knowledge of quality will champion the continued development of their products and growing success.

QA Specialist:

+ This role requires extensive experience in a GMP Operations in the Biotec, Pharmaceutical or Medical Devices Industries.

+ Perform review of batch records for final product, in process testing, QC release testing data packages, Environmental monitoring, labeling, packaging and all supporting documentation.

+ Perform lot disposition.

+ Inspect, review, and disposition raw materials, reagents and components.

+ Conduct line clearances, in-process inspections, support final product packaging and ship out.

+ Handle deviations in real time, ensure that root cause has been identified and appropriate CAPAs has been completed.

+ Facilitate investigations, root cause analysis and CAPAs relating to the GMP activities. Drive and conduct cross functional investigations and issue interim and final reports.

+ Provides Quality oversight and GMP guidance to manufacturing, QC and all departments across the site.

+ Support and coach employees from a GMP knowledge perspective

+ Review, approve and revise SOPs, protocols and reports.

+ Support doc control activities


+ 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

**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: 2020-10-12 Expires: 2020-11-12

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Quality Assurance Specialist: Day and Swing shifts available (San Jose, CA)

Kelly Services
San Jose, CA 95115

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