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QA Specialist

Company: Biotech
Location: Pomona
Posted on: January 15, 2022

Job Description:

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.We focus on providing quality consulting services to ensure our client's success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer's expectations. We are looking for a senior-level QA Specialist.Responsibilities Provide QA support for various capital projects Provide QA support as for the routine Requalification Program Responsible for QA documentation review of validation protocols and final reports as well as any other Validation/Engineering documents which are project related. Provide quality oversight to Validation, Engineering and Manufacturing in order to ensure compliance of documentation to internal procedures as well as regulatory requirements. Requirements 6-10 years of relevant QA experience in Biotechnology, Pharma, and/or Medical Device industry Strong technical background Demonstrate a strong knowledge of Validation and Aseptic Manufacturing principles Excellent understanding of Manufacturing process equipment such as isolators, lyophilizers and autoclaves is preferred Other Equipment and Systems Experience: Filling Line Equipment, External Parts Washer Must have experience with aseptic manufacturing Strong Technical Writing skills Strong IQ, OQ, PQ knowledge User Requirements Specifications experience #LI-PM1

Keywords: Biotech, Pomona , QA Specialist, Other , Pomona, California

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