Technical Resources International, Inc.

Quality Assurance Manager

Technical Resources International, Inc. Bethesda, MD
Technical Resources International, Inc.

Quality Assurance Manager

Technical Resources International, Inc. Bethesda, MD
5 days ago 100 applicants

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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

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Pharmaceutical Manufacturing

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