Quality Auditor - GLP/GCP

Role: Quality Auditor specializing in GLP/GCP compliance within a clinical research laboratory setting. Objectives: ensure operations adhere to global regulatory standards and best practices, support quality assurance initiatives, and facilitate inspections. Responsibilities: perform audits per the audit activity table, contribute to QA policies, provide expertise for CAPA plans, host external audits/inspections, support QA-client relationships, deliver audit training, and report quality metrics to drive continuous improvement. Requirements: Bachelor’s Degree in Pharmacy, Chemistry, or Biology; 6+ years in GLP/GCP regulatory environments; 2+ years of auditing experience; postgraduate degree (MSC or equivalent) preferred. High-Value: focus on laboratory quality systems, regulatory compliance (GCP/GLP, ISO 15189, ISO 13485, CAP), and supporting global QA initiatives. Worksetup: onsite in Indianapolis, IN, with standard work hours; travel requirements not specified.