Senior QA Release Specialist: Regulatory Docs & Compliance

Posted yesterday

boehringer ingelheimGainesville (FL)

Regulatory Affairs Specialists Biological Product (except Diagnostic) Manufacturing

SENIORITY

Senior

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About the role

Boehringer Ingelheim is seeking a QA Release professional to review batch records, ensure regulatory compliance, and support release documentation for biologics. You will act as a deputy to the Qualified Person and collaborate with QA, manufacturing, and regulatory teams. Responsibilities include review of COAs, change controls, deviations, CAPAs, and SAP movements. The role requires hands-on expertise in regulatory requirements and excellent documentation skills.

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