QA Auditor
Job in
Rockville, Montgomery County, Maryland, 20849, USA
Listed on 2026-10-17
Listing for:
Medix™
Full Time
position Listed on 2026-10-17
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
- Plan, execute, and document GCP audits of clinical sites, CROs, vendors, Trial Master Files (TMFs), and internal quality systems.
- Conduct vendor qualification and periodic requalification audits.
- Assist with GLP, GMP, and quality system audits as needed.
- Develop and maintain audit documentation, including audit plans, reports, findings, and closure records.
- Evaluate audit responses, root cause investigations, and Corrective and Preventive Action (CAPA) plans.
- Confirm the timely implementation and effectiveness of corrective and preventive actions.
- Ensure compliance with applicable GCP, GLP, GMP, FDA, ICH, and other regulatory standards.
- Assist with regulatory inspection preparation and inspection-readiness activities.
- Provide quality and compliance support to cross-functional teams.
- Support continuous improvement initiatives and maintain quality assurance procedures and documentation.
- Perform additional duties as assigned.
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Chemistry, Biology, or a related scientific field.
- Minimum of five years of Quality Assurance experience within the biotechnology, pharmaceutical, or clinical research industry.
- At least three years of GCP auditing experience, including clinical sites, CROs, and vendors.
- Working knowledge of ICH GCP guidelines, FDA regulations, and clinical quality systems.
- Experience with CAPA management, root cause analysis, and risk-based auditing practices.
- Strong written and verbal communication skills.
- Excellent organizational, analytical, and problem-solving abilities.
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