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
Qualifications:
- 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
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