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CQA Consultant (232526) Remote – CA

Northwest, West Coast, United States

The CQA Consultant will collaborate with Clinical Study Management team, Safety personnel, Data management, CROs and Clinical Research Sites to provide operational quality audit oversight and implement high level quality as it relates to the client's global clinical trials.

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Tech Writers – (232520) Remote – CA

Remote, Southwest, West Coast, United States

Technical Writer II is responsible for supporting Manufacturing Operations by creating, revising, and maintaining manufacturing and testing procedures. This role works cross-functionally with Quality and Operations teams to develop comprehensive procedures and documents that meet regulatory compliance requirements.

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Regulatory CMC (Director Level) (232502) – Remote, CA

Southwest, West Coast

Seeking a Director-level Regulatory CMC Consultant with a strong background in CMC/Module 3 technical writing for IND & BLA submissions, pre-approval inspections (PAI’s), and cell therapy products.

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