GLP Auditor for Animal Studies & Data Integrity

Pharmatech Associates; Raleigh (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

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

The GLP Auditor will provide independent assessment of contract GLP laboratories, review data integrity, and prepare comprehensive audit reports. The role requires traveling to audit sites and communicating findings clearly to stakeholders.

Qualifications

• At least 5 years of experience in GLP Quality Assurance, nonclinical research, or regulated auditing.
• Willingness to travel to perform audits.
• Strong knowledge of 21 CFR Part 58 requirements.
• Experience auditing nonclinical facilities and studies in pharma/biopharma.
• Experience with study audits, critical-phase audits, facility assessments and 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 regulatory requirements.
• Assess the effectiveness of the facilities QAU including study oversight.
• Assess the adequacy of controls surrounding analytical methods, method validation and laboratory procedures.
• Examine the qualification, calibration, maintenance and status of equipment.
• Evaluate computerized systems and electronic data environments, including validation, access, audit trails, data controls and retention.
• Assess animal research environments, housing, care and documentation.
• Prepare audit agendas and comprehensive audit reports clearly distinguishing findings and risks.
• Review remediation and CAPA plans and verify corrective actions.
• Provide practical recommendations on SOPs, processes and controls.

Skills

GLP QA

Regulated auditing

Technical writing

Data integrity

Job description

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

The GLP Auditor will provide independent assessment of contract GLP laboratories, review data integrity, and prepare comprehensive audit reports. The role requires traveling to audit sites and communicating findings clearly to stakeholders.