Manufacturing Quality Engineer
Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Country: United States
Location : San Francisco, California
Post: Thu, 23 Mar 2023 06:34:32 GMT
Expires: Thu, 20 Apr 2023 23:59:59 GMT
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—————————— Job Description ——————————
Engineering consultant needed to provide manufacturing quality support for a biotech innovator
DUTIES & RESPONSIBILITIES:
Manage equipment changes, validation status, maintenance, user requirements, etc.
Functional Specification, Detail Design Specification, and SOP development and review *
Support audits, new product introduction, continuous improvement and relevant document reviews and approvals
Other duties, as required.
QUALIFICATIONS & REQUIREMENTS:
3+ years of relevant GMP Manufacturing Quality support experience in the pharmaceutical / biotech industry(ies)
Experience with utilizing concepts and tools related to operational excellence, six sigma and Quality by Design
Experience generating GMP documentation such as batch records and SOPs
Relevant B.S. degree
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