What are the responsibilities and job description for the Quality Assurance Manager position at Technical Resources International, Inc.?
Job Description
- Conducts clinical site audits (domestic and international) verifying regulatory compliance and protocol compliance.
- Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations.
- Reviews clinical audit reports and provides guidance to auditors.
- Supports inspection readiness program.
- Serves as a subject matter expert for quality.
- Promotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System.
- Hosts client audits, conducts external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigations.
- Supports regulatory authority inspection.
- Experience working in Quality Assurance GCP internal and client audits (minimum 5 years).
- Experience working with eQMS.
- Proficiency in MS Office.
- Experience with supervising staff.
- Travel 25% (local, domestic, and international).
- Minimum a B.S/B.A., Certified Quality Auditor (CQA) preferred, advanced degree preferred.