Auditor - GCP
On-site · King of Prussia, Pennsylvania, United States or Kankakee, Illinois, United States
Job Summary
Auditor - GCP role focused on executing external audits of clinical investigator sites, CROs, E-System providers, and IRBs/ECs; develops comprehensive audit reports, categorizes findings by risk, and recommends CAPA to improve trial conduct and data integrity. Requires BS in a related field, QA experience in a GCP-regulated environment, robust audit expertise, strong communication, and ability to travel up to 50%. Knowledge of ICH E6 and SOPs, with a focus on risk-based, compliant clinical trial management and monitoring.
Required Qualifications
- BS degree in a relevant biological science, science, or related discipline
- Quality Assurance experience within a GCP-regulated environment
- Audit Expertise: experience in clinical audit and inspection management
- Excellent interpersonal and negotiation skills; ability to work with multinational teams
- Organizational agility; ability to work with limited supervision and manage travel up to 50%
- Strong analytical and problem-solving skills
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