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1+ months

Quality Assurance Associate III

Kelly Services
Mountain View, CA 94035
Quality Assurance Associate III, Mountain View, CA



Salary: 77-90K annually



Responsibilities




+ Ensure the safe release of cellular products in accordance with company and/or client procedures and requirements.

+ Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs

+ Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.

+ Author and review relevant SOPs, validation and other documents.

+ Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.

+ Responsible for the completion of all client requirements related to cellular product and/or material releases.

+ Master Batch Record Control, distribution and label verification

+ Perform line clearance activities as required.

+ Assignment and maintenance of product Lot numbers as applicable.

+ Perform internal documentation audits as assigned.

+ Materials management nonconformance disposition and release activity as applicable.

+ Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures

+ Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.

+ Track and trend relevant quality metrics including environmental monitoring data.

+ Provide Quality Assurance related support to various departments.

+ Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.

+ Electronic Document Control activities as assigned.



Qualifications:




+ Bachelor of Science in a scientifically related field

+ Minimum 5 years experience in QA in a biologics of biotechnology company, pharma, etc.

+ Working knowledge and technical understanding of the aseptic manufacture of biologics

+ Experience in reviewing cGMP/cGTP related documents validation/qualification reports, SOPs etc

+ Experience in organizing teams for effective and timely completion of projects.

+ Understanding of quality system applications

+ 5 plus years of a progression of quality systems management in a manufacturing environment under USDA and/or FDA and HACCP






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



Kelly Science 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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-11-11 Expires: 2020-04-09

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Quality Assurance Associate III

Kelly Services
Mountain View, CA 94035

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