**Hybrid Role in Columbus. Ohio**
Job opportunity with a top Biotech/Pharmaceutical company that is looking for a Quality Assurance Professional to join their team on a 6-month contract.
Qualifications:
- BS/BA Degree in a scientific discipline. Advanced degree preferred.
- 5+ years experience in a related regulated industry
- 2+ years in a GLP or clinical laboratory Quality Assurance or Quality Control role.
- Technical knowledge of nonclinical GLP studies and bioanalytical and clinical test method validations
Job Description/Skills:
- Conduct protocol and protocol amendment reviews, in-study inspections, and data and report audits for nonclinical, method validation, and clinical sample testing studies for compliance to applicable regulations (GLP, GCP), methods, and SOPs.
- Perform facility inspections to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with GLP regulations.
- Review other controlled documents, e.g., Test Methods, and select SOPs and Policies, as requested by Testing Facility Management.
- Review of quality events associated with the site GLP activities including deviations, investigations, CAPAs, quality metrics.
- Support internal, Sponsor or regulatory inspection activities at the OH site.
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
