Auditing, Biotech and Pharmaceutical, Case Report Form (CRF), Communication Skills, Computer Systems, Data Quality, Environmental Protection Agency (EPA), GCP (Good Clinical Practices), GLP (Good Laboratory Practices), GxP, Information Technology/Systems Audit, Maintain Compliance, Mentoring, Multitasking, Procedure Implementation, Quality Assurance, Quality Management, Quality Metrics, Standard Operating Procedures (SOP), System Operations, Training/Teaching, Writing Skills
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
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
US- QA Auditor I,II or III