QA GCP Specialist, Pharmaceutical Product Development
St. Louis, MO

Great QA Opportunity with Global Pharmaceutical Leader!

The QA GCP Specialist will ensure compliance of clinical research operations with SOPs, corporate policies, industry standards, and applicable regulations and guidelines. This will be achieved by auditing CRO’s personnel to proactively ensure compliant research practices, and to verify this compliant status by audits of internal processes, systems and records, clinical investigator sites, and vendors utilized in support clinical trials.

Requirements:
BS Degree and at least 5 years relevant experience, a minimum of 3 years working in a pharmaceutical Quality Assurance or related environment with a minimum of 5 years overall experience working in clinical research.
Experience in leading and participation in audits with a GCP focus, as well as a practical working knowledge of drug development are necessary.
Comprehensive working knowledge of state and federal regulations pertaining to Good Clinical Practices and ICH guidelines.

The candidate must be willing to travel domestically and internationally up to 40% during peak workloads.

Candidates should submit resumes in WORD.

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