QA Auditor
About The Position
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) · 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
Mid Level
Number of Employees
251-500 employees
