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Quality Specialist

Boston

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Our client is seeking a Contract Quality Assurance Specialist near Boston, MA!

Our client is an integrated global leader in pharmaceutical synthesis & specialty ingredients, delivering outstanding performance, unrivaled market responsiveness, and tailored-made solutions to its customers. The company offers their customers custom-development small-molecule active pharmaceutical ingredients as well as in vitro diagnostic services. They are a mid-sized company that is experiencing growth, offering an upside to potential upward-mobility in the future.

Specific Responsibilities:

  • Proactively perform Quality Assurance functions in compliance with cGMP applying regulations IVH Q& and 21 CFR 211
  • Contribute to daily Quality Assurance Operations
    • Product release
    • Review, edit, and approval of controlled quality documentation
    • Quality investigations
    • Inspection/internal audits
    • Supplier qualification
    • External auditing as needed

Qualifications:

  • Bachelor’s degree in a related field of science, or equivalent formal training and experience
  • 2-5 years of experience in cGMP quality, regulatory, or chemical manufacturing environment
  • Advanced demonstrated knowledge in…
    • Analytical services
    • Manufacturing (including batch processing & record review)