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Quality Assurance Specialist

1 month ago

Nashville, Tennessee, United States August Bioservices Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at August Bioservices. As a Quality Assurance Specialist, you will play a critical role in supporting incoming new client projects from the Quality perspective.

Key Responsibilities:

  • Represent the Quality function in internal and external meetings related to new client projects.
  • Determine deliverables and timelines, and communicate upcoming activities with all of the Quality Organization.
  • Support technology transfer of product and processes from clients into August Bioservices manufacturing and laboratories from the Quality perspective.
  • Work cross-functionally with various internal departments to effectively transfer and maintain processes in the facility.
  • Help proactively identify CMC critical path items, risks, and impediments to successful transfer, and drive the identification and development of solutions to help mitigate these risks.

Requirements:

  • Bachelor's or Master's Degree and 5+ years of experience in Quality Assurance within a biotechnology, biologics, or pharmaceutical manufacturing facility.
  • Proven track record with CMC and technology transfer.
  • GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.