Responsibilities
(QA Auditor I, II, III)
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Audit documents against regulatory requirements; GLP, GCP, EPA, OECD, 21CFR Part 11
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Verify lab tasks are performed in accordance to Good Documentation Practices (GDP)
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Audit laboratory documents and notebooks (e.g. plans, experiment/sample runs, chromatograms, instrument logs, etc.) for compliance to SOPs and applicable regulations
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Audit data files and reports
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Audit computer systems, facility operations, and other non-study regulated activities
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Assist with maintaining Master Schedule
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Identify non-compliance, deviations, and Quality events and assist with resolution
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Escalate data integrity and non-compliance issues to Management
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Follow applicable SOPs and procedural documents
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Assist with template and SOP review
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Participate in client audits as needed
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Enforce lab SOPs and requirements
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Review system audit trails
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Other tasks as assigned
(QA Auditor II and III)
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Conduct quality training as needed
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Track and present quality metrics
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Perform vender qualifications and audits
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Train and mentor lower level Auditors
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Review and evaluate procedures to improve quality and efficiency
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Participate in CAPAs and investigations as needed
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Review and author templates and SOPs
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Other tasks as assigned
Skills, Education & Qualifications
- BA/BS or higher; all experiences will be evaluated
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1-7 years experience in GxP Environment, all experiences will be evaluated
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Knowledge of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP
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Familiar with pharmaceutical or biotechnology industry
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Able to review detailed data and documents
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Able to work effectively and contribute within a team
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Able to work with computer systems
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Able to document and communicate clearly; Ability to multitask and to perform & learn in a fast-paced environment
US- QA Auditor I,II or III
