Transcript: Inspector-Reviewers: Bridging the past and Future
In 1913, The Civil Service Magazine stated that the duty of an inspector in the U.S. Food and Drug Administration is to:
“Inspectors assist in the enforcement of the Food and Drugs Act of 1906 by collecting samples of products for analysis, collecting evidence of the shipment of such products, and paving the way to successfully prosecute violations..”
More than 100 years later, inspectors-reviewers in FDA’s Center for Drug Evaluation and Research, known as CDER, are still uncovering problems, righting wrongs, and ensuring drug products are developed and manufactured based on good science and design.
And there is still a need for high-quality inspector-reviewers. CDER is looking for scientists that
- are analytical,
- thrive in collaborative work environments, and
- have a desire to impact many lives.
In CDER, the Bioequivalence and Good Laboratory Practice inspection programs need expert scientists to inspect bioanalytical and non-clinical labs. These inspector-reviewers evaluate sites, conducting clinical and non-clinical studies. They review inspection findings to determine any possible impact on new drugs, generic drugs, and biologics.
“There is no doubt that our country has a considerable number of ambitious men and women who can help improve the development of drug products and promote the health of their fellow Americans.”
CDER directs and reviews inspections of
- drug manufacturers,
- imported drug products,
- clinical investigators,
- drug development sponsors,
- specific complaints,
- drug-manufacturing facilities, and
- post-marketing reporting sites.
CDER inspector-reviewers specifically participate in the inspection of:
- sites that conduct bioanalysis of samples from subjects participating in clinical studies and;
- non-clinical laboratories that follow the Good Laboratory Practices regulations.
Basic qualifications require at least a bachelor’s degree with 30 semester hours or experience in areas like biological sciences, chemistry, pharmacy, and medicine. Advanced degrees with knowledge and hands-on experience with bioanalytical techniques of both small and large molecules is also desired. Coursework or experience in computer programming and statistics helps…
…so does a willingness to relocate to the Washington, D.C. area.
Once hired, there are opportunities to travel throughout the United States and around the world.
While the qualifications set a high bar, those that meet the requirements can guarantee themselves a rewarding career.
“The experience and training of an inspector is a valuable course in the university of life. And the degree conferred by this university spells S-U-C-C-E-S-S."
Do your research and learn what CDER’s inspector-reviewers already know: how satisfying it is to work for the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research.