Senior QA Specialist - Validation & Compliance
BioSpace, Inc.
Novo Nordisk seeks a Site Clayton QA Finished Production representative to ensure batch release and quality oversight for validation activities. You will review complex CRs, DV/CA PA documentation, and provide coaching for audits while maintaining a validated state of equipment and processes. The role requires strong GMP experience, regulatory knowledge, and ability to lead cross-functional investigations, with on-site Monday–Friday expectations in Clayton, NC. #J-18808-Ljbffr BioSpace, Inc.
Vacancy posted 2 days ago
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