QA Auditor
About The Position
(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
Requirements
- 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
Responsibilities
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Professional, Scientific, and Technical Services
