GLP Auditor – Remote/Travel Required, Lab Oversight

Pharmatech Associates, a USP company; Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

Pharmatech Associates, Inc. seeks an experienced GLP Auditor, Contract/Project Consultant to support audits for clients conducting regulated nonclinical research and animal studies.

The role requires evaluating GLP compliance and data integrity across laboratory environments and study documentation. Responsibilities include auditing facilities, analytical systems, and animal housing, and preparing detailed regulatory findings and CAPA recommendations.

Qualifications

• Minimum 5 years in GLP QA, nonclinical research, or regulated auditing.
• Ability to travel to perform audits.
• Demonstrated knowledge of 21 CFR Part 58 requirements.
• Direct experience auditing nonclinical facilities and studies for pharmaceutical/biopharma development.
• Experience with study audits, critical-phase audits, facility assessments, or external partner audits.
• Ability to assess study documentation, raw data, source records, protocols, deviations, and final reports.
• Understanding of ALCOA+ data integrity principles in GLP records.
• Strong technical writing and clear audit communication.

Responsibilities

• Assess compliance with 21 CFR Part 58, study protocols, SOPs, and regulatory requirements.
• Evaluate facilities' QAU effectiveness and study oversight.
• Assess controls around analytical methods, method validation, labs, and test results.
• Inspect equipment qualification, calibration, maintenance, and status.
• Review electronic data systems, validation, access, audit trails, and data retention.
• Evaluate animal research environments and documentation.
• Prepare audit agendas and comprehensive reports detailing findings and impacts.
• Review remediation and CAPA plans for root-cause assessment and effectiveness.
• Provide practical SOP/process improvements recommendations.
• May perform client study audits as part of non-clinical oversight.

Skills

GLP QA

Nonclinical research

Regulated auditing

Travel readiness

21 CFR Part 58 knowledge

Technical writing

Job description

Pharmatech Associates, Inc. seeks an experienced GLP Auditor, Contract/Project Consultant to support audits for clients conducting regulated nonclinical research and animal studies.

The role requires evaluating GLP compliance and data integrity across laboratory environments and study documentation. Responsibilities include auditing facilities, analytical systems, and animal housing, and preparing detailed regulatory findings and CAPA recommendations.