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Senior Quality Assurance Specialist

4 months ago


Norwood, United States Randstad Life Sciences US Full time

Title: QA Quality Systems and Distribution

Duration: 06 months Contract

Location: Norwood, MA

Max PR: $55.00


Job 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.

Education & Qualifications

Sr. Specialist level (5+ years’ experience)

Excellent communication skills

Proficiency in regulatory requirements

Familiarity in Veeva systems or similar quality document management

Experience performing batch record review and batch disposition

Familiarity in Drug Product GMP Manufacturing