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Quality Assurance Compliance Specialist

3 months ago

Norwood, United States Randstad Life Sciences US Full time

A global Pharmaceutical company whose focus is to create better health for people and a brighter future for the world. We move science forward, so we can transform more lives.

Join this team if you want to Work with globally diverse colleagues who are committed to bringing Better Health to people and a Brighter Future to the world.


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