Description of Duties:
- Prepares for and conducts inspections of sites that perform nonclinical or clinical studies that have safety, efficacy, pharmacokinetic, bioavailability, bioequivalence, or pharmacodynamics or clinical endpoints.
- Inspects and evaluates biopharmaceutical laboratory processes, personnel, documentation, storage facilities, and instrumentation for their capacity to generate accurate and reliable data.
- Provides authoritative advice and guidance regarding aspects of inspectional findings, laboratory processes, laboratory data, or studies which fall in assigned area of review.
- Reviews FDA staff inspection reports of clinical and nonclinical sites as well as clinical studies and nonclinical studies, including human and animal pharmacokinetic, bioavailability, or bioequivalence studies for human drugs.
- Reviews non-FDA generated inspection reports of clinical or nonclinical sites, or clinical or nonclinical studies.
- A four-year bachelor degree that included a major in an appropriate biological, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology and 12 semester hours in pharmacology.
- GS-12/13 at the headquarters and field levels