GLP Auditor, Part 58, Animal Studies

Apply Location: Raleigh, NC (Remote Available)

About the role

The GLP Auditor will provide independent assessment of contract GLP laboratories and their associated work as part of supplier oversight processes. The role requires the ability to assess not only whether procedures are followed, but also whether the resulting data can be relied upon, reconstructed, and supported by appropriate documentation. The successful candidate will be comfortable working directly with animal study records, laboratory data, protocols, raw data, computerized systems, equipment, facilities, and final reports, while applying the requirements of 21 CFR Part 58 and applicable regulatory expectations.

Responsibilities

• Assess compliance with 21 CFR Part 58 principles, study protocols, SOPs, and applicable regulatory requirements.
• Assess the effectiveness of the facilities QAU including study oversight.
• Assess the adequacy of controls surrounding analytical methods, method validation, laboratory procedures, system suitability, and test results, as applicable.
• Examine the qualification, calibration, maintenance, and operational status of laboratory and study equipment.
• Evaluate computerized systems and electronic data environments, including validation status, user access, audit trails, data controls, and record retention.
• Assess animal research environments, including animal identification, housing, care, environmental controls, facility practices, and associated documentation.
• Prepare audit agendas and comprehensive audit reports that clearly distinguish regulatory findings, quality risks, supporting evidence, and potential impact on study integrity.
• Review proposed remediation and CAPA plans, assess root-cause considerations, and verify that corrective actions are appropriately implemented and effective.
• Provide practical recommendations regarding SOPs, processes, training, documentation practices, and quality controls where improvements are needed.
• May be required to perform study audits as part of our client’s non-clinical study oversight.

Qualifications

• At least 5 years of experience in GLP Quality Assurance, nonclinical research, or regulated auditing.
• Must be able to travel to perform audits.
• Demonstrated working knowledge of 21 CFR Part 58 requirements.
• Direct experience auditing nonclinical facilities and studies to support pharmaceutical or biopharmaceutical product development.
• Experience performing study audits, critical-phase audits, facility assessments, and/or external partner audits.
• Ability to independently assess study documentation, raw data, source records, protocols, deviations, and final reports.
• Understanding of data integrity principles, including ALCOA+ expectations, and their practical application to GLP records.
• Strong technical writing skills and the ability to communicate audit conclusions clearly and objectively.