Qualifications for an FDA Investigator

by Laura Scott
FDA investigators test and analyze many consumer products.

FDA investigators test and analyze many consumer products.

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U.S. Food and Drug Administration investigators track the safety, quality and effectiveness of of consumer products such as food, drugs, veterinary medications, medical devices, vaccines and cosmetics. Unlike FDA inspectors who conduct routine checks of manufacturers and products to make sure they are in sync with federal regulations, FDA investigators respond to problems such as outbreaks of illness, reports of injury and consumer complaints. FDA investigators also run clinical trials of new drugs and follow-up studies on medications. Some gather evidence to prosecute crimes such as product fraud and product tampering. The qualifications for an FDA investigator vary depending on the job and the grade level of the position.

Consumer Safety Officers

Consumer safety officers investigate incidents of illness, injury and death and reports of product tampering and fraud. They collect samples of products, interview victims and product manufacturers, and check manufacturing sites for possible sources of contamination. They also analyze product samples and review manufacturing records, product labels and advertising. Safety officers need a minimum of a bachelor's degree in biology, chemistry, nutrition or other scientific field. Those interested in the lab or paper trail sides of investigations also need a science-related bachelor's degree and additional training in other skills such as statistics and computer programming. Safety officers jobs are defined by grade levels. Higher-grade jobs often require graduate degrees and experience in a similar position.

Other Investigator Roles and Requirements

FDA safety officers also investigate food, drug and product safety problems in overseas manufacturing plants operated by U.S. companies. They are typically part of the first-response teams in the wake of natural disasters such as floods, earthquakes and hurricanes and man-made catastrophes such as riots, terrorists attacks and hazardous material spills. In those positions, safety officers must have knowledge and experience in contamination containment and disposal methods. All FDA safety officers must be U.S. citizens.

Clinical Trial investigators

The FDA loosely defines the qualifications for investigators who conduct clinical trials on new and existing drugs. Universities and pharmaceutical companies that sponsor drug trials must hire investigators who are considered experts by virtue of their education and experience. However, the appropriate level of education and experience is left to the sponsor's judgement. Investigators do not need a medical degree, but the FDA does require a medical doctor to be listed as a subinvestigator in a clinical trial in case medical problem arise. Investigators must have supervisory skills to oversee employees helping to conduct tests, and they must also understand how to provide care and protection for participants in clinical trials. In many cases clinical trial investigators must also provide financial information to show they have no conflicts of interest.

Criminal Investigators

In 1991, the FDA launched its Office of Criminal Investigations to gather evidence and help prosecute cases of fraud, tampering, theft and other crimes involving food, drugs,cosmetics and other products subject to FDA regulation. The agency typically hires seasoned law enforcement professionals with experience on the federal level. OCI agents train at the Glynco, Ga., branch of the Federal Law Enforcement Training Center, and participate in ongoing in-house training in FDA law, electronic and financial crime, and investigation techniques.

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