GLP Auditor: Animal Studies & Data Integrity Expert

Pharmatech Associates; Chicago, Northern (IL, KY); Hybrid; USD 100,000 - 170,000; Full time

Job summary

Pharmatech Associates, Inc. is seeking an experienced GLP Auditor, Contract/Project Consultant to independently assess GLP laboratories and related data as part of supplier oversight.

The role requires evaluating compliance with 21 CFR Part 58, data integrity, study records, and reporting; travel is required to perform audits at client sites. You will prepare audit agendas and reports, and recommend CAPA actions to strengthen SOPs, processes, and training.

Qualifications

• 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.

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.

Skills

GLP Quality Assurance

Nonclinical research

Regulated auditing

Study audits

Technical writing

Data integrity ALCOA+

Job description

Pharmatech Associates, Inc. is seeking an experienced GLP Auditor, Contract/Project Consultant to independently assess GLP laboratories and related data as part of supplier oversight.

The role requires evaluating compliance with 21 CFR Part 58, data integrity, study records, and reporting; travel is required to perform audits at client sites. You will prepare audit agendas and reports, and recommend CAPA actions to strengthen SOPs, processes, and training.