This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band C.
In order to qualify for the Consumer Safety Officer position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/14/2025: Basic Qualification Requirements: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0600/consumer-safety-series-0696/. Have a bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming. OR Have a combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. AND IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. Have a bachelor's degree and have 4 years of comparable experience in regulatory oversight related to FDA products (food, dietary supplements, biologics, drugs, devices or imports) or manufacturing of foods, dietary supplements, biologics, drugs or devices in compliance with CGMP (Current Good Manufacturing Practices), PC (Preventive Control), HACCP (Hazard Analysis Critical Control Point), and/or FSVP (Foreign Supplier Verification Program); and/or manufacturing process deviation investigations and/or root cause investigations; knowledge of laws, regulations, policies and guidance used in regulating foods, dietary supplements, biologics, drugs, devices or imports. OR Have a master's degree and have 3 years of comparable experience in regulatory oversight related to FDA products (food, dietary supplements, biologics, drugs, devices or imports) or manufacturing of foods, dietary supplements, biologics, drugs or devices in compliance with CGMP (Current Good Manufacturing Practices), PC (Preventive Control), HACCP (Hazard Analysis Critical Control Point), and/or FSVP (Foreign Supplier Verification Program); and/or manufacturing process deviation investigations and/or root cause investigations; knowledge of laws, regulations, policies and guidance used in regulating foods, dietary supplements, biologics, drugs, devices or imports. OR Have a Doctorate and/or J.D. degree and have 1 years of comparable experience in regulatory oversight related to FDA products (food, dietary supplements, biologics, drugs, devices or imports) or manufacturing of foods, dietary supplements, biologics, drugs or devices in compliance with CGMP (Current Good Manufacturing Practices), PC (Preventive Control), HACCP (Hazard Analysis Critical Control Point,), and/or FSVP (Foreign Supplier Verification Program); and/or manufacturing process deviation investigations and/or root cause investigations; knowledge of laws, regulations, policies and guidance used in regulating foods, dietary supplements, biologics, drugs, devices or imports. OR Have a MD, DO, DDS, DPM, or DVM degree and 0 years of comparable experience.
Reviews recommendations for potential administrative and judicial actions based on adulteration charges under the Food Drug & Cosmetic (FD&C) Act to ensure consistency and adherence to FDA policy. Provides enforcement decision and compliance strategies based on review of evidence of violations, compliance policy, public health risks, and availability. Reviews inspection reports submitted by field investigators and other information and data to determine compliance with applicable laws and regulations, and the need for follow-up investigation by the field, and serves as a senior expert, advisor, and technical authority on complex regulatory issues. Implementing and managing a full range of compliance actions, both administrative and judicial, including casework and related functional responsibilities in the area of human foods. Provides scientific and technical input on compliance issues and in regulatory meetings to ensure consistency of interpretation of Current Good Manufacturing Practices (CGMPs), Preventive Controls, HAACP (Hazard Analysis Critical Control Point), Foreign Supplier Verification Program or other foods regulations. Provides expertise to address significant manufacturing problems or quality defects and collaborates with other regulatory partners to develop and execute compliance programs and actions related to manufacturing quality and safety of foods and dietary supplements. Independently conducts in-depth evaluations of complex and high-profile regulatory issues, including emerging public health risks, new technologies, and systemic compliance challenges. Serves as a principal advisor and compliance subject matter expert to agency leadership on technical, legal, and policy matters. Leads or participates in cross-functional working groups, regulatory task forces, and agency-wide initiatives focused on enhancing program effectiveness (including training), developing enforcement policies, and improving national compliance outcomes. Provides technical expertise in CGMPs and other foods/dietary supplement related regulations compliance and/or regulatory issues related to manufacturing of foods and dietary supplements.