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1+ months

Sr. FDA Quality Assurance Specialist - Permanent

Kelly Services
Vacaville, CA 95687
Kelly Science & Clinical has a new, permanent opportunity for an experienced FDA Quality Assurance Specialist with a Biopharmaceutical company in San Jose, CA. Relocation assistance is offered!


Day-to-Day Responsibilities:


+ Develop, establish, and maintain Quality Systems and procedures in compliance with GMP standards

+ Develop, maintain, and improve environmental monitoring program

+ Oversee process and personnel monitoring during aseptic processing operations

+ Review and revise SOPs, study protocols, reports, and other technical documents

+ Review and approve validation and qualification packages including IQ/OQ/PQ protocols

+ Inspect, review, dispose, and initiate investigations related to manufactured products and raw materials

+ Facilitate investigations, root cause analysis, and CAPAs

+ Perform review of batch records

+ Coordinate final release of products


You are a great fit if you meet the following qualifications:


+ BS in STEM discipline

+ Must have 5+ years Quality Assurance experience, preference given to FDA and supplier audits experience

+ Must have at least 8 years of GMP-regulated experience

+ Must have either experience in aseptic processing, cell therapy, and/or FDA inspections

+ Must have above average communication skills, both written and verbally

+ Previous supervisor or team lead experience

+ Must be authorized to work in the US


This position is Monday Friday ~8:00am 5:00pm with some overtime required. Salary will be based on years of relevant experience and will range between $100k-$140k. If you, or someone you know, would like to be considered please apply online today to discuss next steps!


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-08-30 Expires: 2021-11-01

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Sr. FDA Quality Assurance Specialist - Permanent

Kelly Services
Vacaville, CA 95687

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