Quality Assurance/Quality Systems Contractor

contract hire - Minneapolis, MN
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Quality Assurance/Quality Systems Contractor

Contract Hire – Minneapolis, MN

Talencio’s client, a novel bio/pharma company located in the north Twin Cities metro, is hiring a Quality Assurance/Quality Systems Contractor for a 6 month, full-time project.

Project Scope:

  • Assisting in Pre-Approval Inspection (PAI) readiness
  • Developing procedures in the areas of supplier quality, training systems-performance based, material controls and qualification, investigation systems, data integrity, recall, product complaints, adverse event (AE) and regulatory reporting
  • Reviewing technical documents from other departments
  • Reviewing and approving cGMP documents and/ or regulatory submission documents for compliance to internal procedures and applicable regulations
  • Managing projects


  • Bachelor’s Degree in scientific or engineering field
  • Experience in 21 CFR 210 – 211 and/or 600-610 GMP regulations
  • Previous experience in a Quality Assurance role
  • Knowledge of standards, current industry practices, and familiarity with interpretation and application
  • Experience with implementing Quality Systems, authoring/revising Quality procedures/designing compliant frameworks/and implementing continuous improvement initiatives
  • Well versed in designing, implementing, and monitoring several Quality Management Systems
  • Prefer 10 + years experience or 5 – 10 years of experience with a large range of building various quality systems