Manufacturing Quality Engineer

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 ——————————

SUMMARY:

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