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Quality Assurance Associate

Company: Yoh Services LLC
Location: Novato
Posted on: August 6, 2022

Job Description:

Yoh is seeking a Quality Assurance Associate to support our Genomics client in the San Francisco Bay Area. The Quality Assurance Associate will primarily responsible for the Batch Record Review and Document Control processes . This position requires an AA, AS in Chemistry, Biochemistry, Biological Sciences or a similar scientific discipline or equivalent combination of education and experience . Pay Rate : Depending on experience Industry: Genomics Location : San Francisco Bay Area Type : Contract to Hire Responsibilities Review of batch production records for completeness and release Review of analytical records and any supporting documentation to ensure compliance with cGMPs, policies and procedures. Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations. Perform routine document control activities including creation and/or revision, processing, routing and review. Work with various departments to set up appropriate documentation to improve efficiency and accuracy. Assists in performing QC data review for batch record in-process and final QC approval. Assist with internal Quality audits of internal departments, as necessary. Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance Qualifications AA, AS in Chemistry, Biochemistry, Biological Sciences or a similar scientific discipline or equivalent combination of education and experience. 2-3 years' experience in a diagnostics or medical device environment Preferred; Quality Assurance experience preferred Experience with Batch Record Review, Product Disposition and Document Control. Familiarity with ISO 9001:2008, ISO 13485:2003 and 21 CFR 820. #Zip-SPG#Mon-SPG#CB-SPG#IND-SPG

Keywords: Yoh Services LLC, Novato , Quality Assurance Associate, Other , Novato, California

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