Randstad Life Sciences US · 1 day ago

Quality Assurance Compliance Specialist

Norwood, MA

Contract

Onsite

Senior Level

$40/hr - $60/hr

5+ years exp

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Pharmaceutical Manufacturing

Actively Hiring

Hiring Manager

Charulatha Vedhachalam-Felse

Insider Connection @Randstad Life Sciences US

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Responsibilities

Perform the release process confirmation for CMO batches, including Veeva documentation checks and SAP release steps.

Conduct batch record review as needed

Administration support for documentation archive in Veeva eQMS

Ensure compliance with required training

Resolve issues with CMO documentation in collaboration with CS leads and CMO leads

Depending on skill set and previous experience, there may be need to rotate to support Compliance, operational excellence project work and/or quality project management teams.

Qualification

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Regulatory requirementsVeeva systemsBatch record reviewBatch dispositionDrug Product GMP Manufacturing communication skills