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Technical Resources International, Inc.

Quality Assurance Manager

Technical Resources International, Inc., Bethesda, Maryland, us, 20811

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Quality Assurance Manager

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Quality Assurance Manager

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Technical Resources International, Inc. 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.

All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.

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.

Job Requirements

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. Seniority level

Seniority levelMid-Senior level Employment type

Employment typeFull-time Job function

Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Technical Resources International, Inc. by 2x Get notified about new Quality Assurance Manager jobs in

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