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 06/13/2025: 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 manufacturing of biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a master's degree and have 3 years of comparable experience manufacturing of biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a Doctorate and/or J.D. degree and have 1 years of comparable experience manufacturing of biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a MD, DO, DDS, DPM, or DVM degree and have 0 years of comparable experience manufacturing of biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have 6 years of comparable experience manufacturing of biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing.
Handle submissions that are more difficult because of the technology, science, and the complex regulatory issues associated with these products. Serve as an expert in biological product manufacturing and provide written and verbal conclusions to FDA components and industry regarding compliance with CGMP regulations and FDA establishment standards. Identify and assess emerging or complex issues, advises supervisors of potential problem areas, and formulates appropriate responses. Serve as a subject matter expert across multiple subject areas demonstrating advanced level scientific knowledge and provides consultation to management and staff to address technical inquiries. Provide verbal and written conclusions regarding these reviews and inspections to FDA components and industry in the form of review memos and inspection reports. Serve on working groups to develop critical guidance for industry pertaining to the manufacture of biologic products. Participate in educating industry and FDA on such guidance through workshops for industry or presentations at industry/FDA conferences. Advise the branch, division and agency staff in the review and evaluation of manufacturing processes and facilities to ensure compliance with the laws and applicable regulations and ensure consistency. Maintain expert knowledge of the Federal Food Drug and Cosmetic Act and noted amendments; the Public Health Service Act; and all other Acts enforced by the Agency, as well as the regulations and policies promulgated under these Acts used in the regulation of biologic products and devices. Perform other duties as assigned.