QA Auditor III - Malvern, United States - Resolian

Description

• 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 assist with resolution
• Escalate data integrity and non-compliance issues to Management
• Follow applicable SOPs and procedural documents
• Conduct quality training as needed
• Track and present quality metrics
• Participate in client and regulatory audits as needed
• Enforce lab safety SOPs and requirements
• Review system audit trails
• 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 assignedEducation, Experience &

• BA/BS or higher with 4-7 years experience in GxP environment; all experiences will be evaluated
• Strong knowledge and understanding of regulatory requirements; GLP, GCP, EPA, OECD, 21CRF Part 11, GDP, GMP
• Familiar with pharmaceutical or biotechnology industry
• Able to review detailed data and documents
• Able to work effectively and contribute within a team; communicating effectively
• Able to work with computer systemsAbout UsAre you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.

We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment.

It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.

If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.