QA Auditor I, II or III

(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)

• Conduct quality training as needed
• Track and present quality metrics
• Perform vender qualifications and audits
• Train and mentor lower level Auditors
• Review and evaluate procedures to improve quality and efficiency
• Participate in CAPAs and investigations as needed
• Review and author templates and SOPs
• Other tasks as assigned

Skills, Education & Qualifications

• BA/BS or higher; all experiences will be evaluated
• 1-7 years experience in GxP Environment, all experiences will be evaluated
• Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP
• Familiar with pharmaceutical or biotechnology industry
• Able to review detailed data and documents
• Able to work effectively and contribute within a team
• Able to work with computer systems
• Able to document and communicate clearly; Ability to multitask and to perform & learn in a fast-paced environment