QA Auditor

Job Description

Responsibilities

(QA Auditor I, II, III)

• Audit documents against regulatory requirements; GLP, GCP, EPA, OECD, 21CFR Part 11
• Verify lab tasks are performed in accordance to Good Documentation Practices (GDP)
• Audit laboratory documents and notebooks (e.g. plans, experiment / sample runs, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations
• Audit data files and reports
• Audit computer systems, facility operations, and other non-study regulated activities
• Assist with maintaining Master Schedule
• Identify non-compliance, deviations, and Quality events and assist with resolution
• Escalate data integrity and non-compliance issues to Management
• Follow applicable SOPs and procedural documents
• Assist with template and SOP review
• Participate in client audits as needed
• Enforce lab SOPs and requirements
• Review system audit trails
• Other tasks as assigned

(QA Auditor II and III)

Skills, Education & Qualifications