Associate Investigator

As Associate Investigator, the incumbent has demonstrated and is recognized for a high level of competence in the full range of commodities regulated within the boundaries of an FDA Program such as foods, drugs, medical devices, imports, etc., or in a narrow specialty within a program area. Assignments involve a combination of scientific and regulatory responsibilities which usually call for a number of atypical inspections, or intensive investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations; and include the difficult and complex sample collections, establishment inspections, unusual or novel special investigations.

Inspections and Investigations:

• Receives fundamental training, through classroom and on-the-job instruction, to provide a more thorough understanding of and exposure to FDA laws and regulations, administrative policies, manufacturing processes, good manufacturing practices, and the various methods employed in the conduct of establishment inspections, sample collections and investigations.
• The investigator independently conducts inspections, investigations, and sampling at lower complexity human food facilities to ensure compliance with FDA laws, policies, and regulation of human commodities in which the employee has received specific or related training.
• Collects samples and conducts field analyses involving environmental sampling and assessment, review for compliance with good manufacturing practices, records review, etc.
• Incumbent interacts with and advises various levels of officials representing the establishments subject to regulatory review. The incumbent initiates contact with industry officials to obtain information on regulatory and scientific documents and to discuss the status of investigations.
• Developmental assignments include assisting higher level employees in inspections or other field activities, meetings, and conference calls with regulated industry. Such assignments with senior Investigators involve complex manufacturing practices, a broad variety of raw materials, advanced instrumentation and complex assembly line operations, diverse manufactured products, and complicated paperwork each of which requires separate manufacturing and inspectional techniques.
• Incumbent conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations. In situations where compliance is not offered, it is enforced through other methods, including administrative action, informational agency meetings, and legal court actions.
• Independently investigates routine consumer complaints. Assists other investigators in the investigation of unusual consumer complaints,
• Performs other duties as assigned.

Analysis and Reporting:

• The incumbent will perform analyses and evaluation on data samples and documented information gathered during inspections and investigations to ensure that documentation and practices follow federal laws, rules, and regulations.
• Documents and organizes required evidence, data, and other information to support violations noted during inspections, investigations, and sample collections.
• Accompanies experienced inspectors to gain exposure in providing professional testimony in court cases in support of legal action.
• May testify as an expert witness in administrative hearings and judicial proceedings.
• Prepares final reports, position papers and other written documentation that support investigative findings and recommendations. Reports are developed and well-written in accordance with quality elements.

Supervisory Responsibilities: This is a non-supervisory role.