Consumer Safety Officer – ORA
Description of Duties
- Reviews and evaluates the largest manufacturers and the most complex investigations of brokers and importers in a FO and some smaller firms where new or unusual features are present.
- Conducts inspections and investigations (domestic and/or international) of facilities where only limited guidance documents are available.
- Investigates and evaluates the adequacy of complex manufacturing practices to determine compliance with regulations.
- Conducts complex, technical investigations and inspections of establishments in the area of assigned responsibility and prepares final reports, investigation memoranda, and proposed or final endorsements.
- Independently performs investigations involving complaints and trace back investigations of injury or death attributable to products regulated by the FDA. Plans and decides how the investigation should proceed, when the investigation is complete, and what reporting is required. Analyzes results, decides when an investigation is complete or what additional work may be required. The investigator is expected to provide timely and accurate feedback to management as well as effective guidance to other staff assisting in the investigation.
- May serve as a team leader or coordinator in the conduct of complex assignments requiring one or more investigators, analysts or outside experts, and/or personnel from other Federal agencies, State or local governments, foreign agencies. As an instructor, trains lower level investigators in the sophisticated inspection and investigation techniques.
- Provides authoritative guidance and consultation regarding inspection and investigation methods and procedures necessary ti accomplish compliance, enforcement and regulatory objectives.
- Works with subject matter specialist in the onsite evaluation of field activities. Identifies areas which warrant further study or improvement and prepares reports to ensure optimum operating efficiency and resource utilization.
- Reviews special and unusual problems submitted by various Center/Offices and provides authoritative guidance to the resolve the issues causing the problems. Such issues frequently deal with interpretations of law, policy and procedures.
- Conducts research into legal precedents and legislative history of the Acts enforced by FDA. Prepares position papers for top FDA managers based on such research. Drafts responses to correspondence from within and outside the agency concerning FDA regulated products.
- Provide support to agency task forces establishing new or receiving regulations, procedures and programs having nation and international impact.
- Prepares and presents informal remarks at briefings, training sessions, consumer industry workshops, etc.
- Attends high level meetings with top FDA staff as a representative of the Agency.
Basic requirements for all grades in this position include:
A. Degree: that included at least 30 semester hours in one or a combination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming (MUST SUBMIT TRANSCRIPTS). –OR-
B. Combination of education and experience -- courses consisting of at least 30 semester hours in the fields of study described in A above, plus appropriate experience or additional education (MUST SUBMIT TRANSCRIPTS).
Grade (Salary) Level
Federal General Schedule (GS) grade levels at which Consumer Safety Officer positions are commonly filled are: GS-5 through 13 at the headquarters and field levels.
Higher graded positions are directly related to additional education and/or specialized experience.
These positions are located at HQ (suburban Washington, D.C.) and in facilities throughout the U.S.