QA Auditor bei Alliance Pharma Co

(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