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**MULTIPLE LOCATIONS**

Location(s): E4 - Jacksonville, FL; Miami Lakes, FL; Maitland, FL; Tallahassee, FL E6 - South Bend, IN; Indianapolis, IN W3 - Dallas, TX; Houston, TX W4 - Lakewood, CO; Salt Lake City, UT; Tempe, AZ W5 - Alameda, CA; San Jose, CA; Fresno, CA; Stockton, CA; Sacramento, CA; Irvine, CA; San Diego, CA; Ontario, CA; Long Beach, CA; Woodland Hills, CA

 

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

 

Introduction

The Food and Drug Administration (FDA) is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured, packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States and abroad.

 

The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 12 laboratories throughout the United States. As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through a) inspections of firms and plants producing FDA-regulated products, b) investigations of consumer complaints, emergencies and criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of imported products.

The mission of the Office of Regulatory Affairs is to protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products. To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs.

 

The Office of Human and Animal Food Operations (HAF) oversees the coordination, interpretation and evaluation of the FDA’s overall field inspections and compliance efforts in the areas of human and animal food and other products regulated by the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Additionally, the HAF program focuses on national and international inspection of a variety of diverse and complex food products and production processes including infant formula, medical foods, low acid canned food and thermal processing, etc.

 

The HAF Program oversees field operations that encompass both food safety and food defense activities to determine compliance with the Food Safety and Modernization Act (FSMA) as well as other FDA laws and regulations, and to ensure the safety of consumers. In addition, the HAF program routinely coordinates emergency response activities, rapid identification of suspect tainted foods, trace forward, and tracebacks to swiftly address emerging issues which have potential to compromise public health. Duties/Responsibilities The Investigator II, Band A, demonstrates competence and conducts inspections of various industry establishments, such as manufacturers, re-packers and own label distributors in the human and animal food area resulting in a range of human and animal food inspection types and food-related investigations. These types of inspections and investigations will account for a level greater than 90% of the CSO’s inspectional/investigative work. Inspections and Investigations

•Serves as an investigator for the Office of Human and Animal Foods in the Office of Regulatory Affairs.

•The incumbent independently conducts inspections, investigations, and sampling at human and animal food facilities to ensure compliance with FDA laws, policies, and regulation o human and animal food commodities.

•Assists the immediate supervisor in planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility; training new personnel, as appropriate; training foreign government personnel.

•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.

•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.

•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 to 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.

•For team inspections, employee gathers scientific and technical comments from team members, assists with the preparation of reports relevant to the inspection, and contributes to status reports for inspections and investigations under review.

•May assist in training state and local government officials to ensure compliance with federal laws.

•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 not a supervisory position.

 

How to Apply

Applications will be accepted from all qualified U.S citizens. Applicants must submit the following: 1) a letter of interest (in pdf format) including name of preferred city(ies), 2) a detailed current résumé, 3) college transcripts (with foreign credentials evaluation if applicable) 4) for current federal employees only, a current SF-50 with only year of birth and last four digits of social security number redacted.

 

IMPORTANT: The application must show this job reference ID and location code in the subject line: 8-Investigator II-HAF Location Code(s). E.g., 8-Investigator II-HAF-E4,E6. Send the above-mentioned documents to ORA Investigator Hiring at: ORAInvestigatorHiring@fda.hhs.gov

 

NOTE: It is your responsibility to ensure the job ID and location is noted in the subject line and the required documentation is submitted prior to the closing date for your application to be considered. Applications will be accepted through May 31, 2024 Candidate resumes may be shared with hiring officials within ORA with similar job vacancies. Candidates can opt out of this process by annotating resume with “do not share”.

 

Announcement Contact For questions regarding this Title 21 position, please contact ORAInvestigatorHiring@fda.hhs.gov and include the following job reference ID: 8-Investigator II-HAF in the subject line.

 

The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.

 

FDA is an equal opportunity employer.