Auditor I, Clinical Quality Assurance

Responsibilities

• Support GCP/GCLP/GVP audits for investigational sites, internal systems, trial master files, and clinical service providers
• Plan, coordinate, and report audits including the escalation of critical observations
• Assist with commercial inspections and inspection readiness activities
• Support GCP compliance activities including investigations, change controls, and procedure development
• Implement procedures and work instructions based on best practices
• Represent the Clinical Quality Assurance Team in cross‑functional projects

Requirements

• BA/BS in life sciences or equivalent field
• 1+ years of GCP or GMP experience
• Knowledge of US CFR, ICH Guidelines, EU, TGA, Health Canada, or MHRA regulations
• Working knowledge of MasterControl, Veeva, or similar eQMS programs
• Proficiency in MS Office (Word, Excel, PowerPoint, MS Project)
• A...