Quality Auditor - GLP/GCP
On-siteIndianapolis, Indiana, United States
Job Summary
Conduct work as identified on the audit activity table to ensure clinical research laboratory testing operations comply with global regulatory standards including GCP/GLP, ISO 15189, ISO 13485, and CAP. Contribute to global QA policies, support subject matter expertise on projects, and assist with CAPA plan creation. Host external audits and inspections, facilitate audit responses, and deliver training in performance of audits across basic, intermediate, and complex levels. Support the QA-to-QA relationship with key clients, participate in global quality initiatives, and report quality metrics to implement corrective actions and process improvements. Work Monday through Friday 8-5 pm in Indianapolis, IN.
Required Qualifications
- Bachelor's Degree in a Pharmacy, Chemistry or Biology related discipline
- 6 years in regulatory environment in GLP/GCP regulatory environment
- 2 years of Auditing experience
- Postgraduate degree (MSC or equivalent) in science or management related discipline
Desired Qualifications
- Experience of industry quality systems/standards
- Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving
- Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios
- Ability to demonstrate effective communication verbally and written with an emphasis on strategic communication with clients
- Excellent organizational and project management abilities
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