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Sourcing-Senior QA Auditor
Medpace Holdings, Inc.
- Coordinate and conduct internal process audits and external investigative site/vendor audits including laboratories (GCLP);
- Create, maintain, and revise departmental standard operating procedures, forms, and templates;
- Coordinate, conduct and track company-wide Regulatory training and Quality Event Management / CAPA
- Host audits by sponsors and regulatory inspectors;
- Coordinate, conduct, and track company-wide regulatory training ((Chinese) ICH GCP and medical device);
- Develop training materials and applicable tests and guides; and
- Work with outside clients/sponsors.
- Act as QA Project Leader, managing timelines and coordinating workload amongst QA Auditors
- Conduct Fraud and For Cause investigations and report to management.
- Used to work in an international team
- Willingness to travel (up to 50%)
- Experience at least 3 years bachelor’s degree and at least 3 years of QA in GCP and GCLP auditing
- Fluent in English (verbally and in writing)
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.
Job posted: 2023-06-22