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The FDA's Office of Regulatory Affairs (ORA) is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement.
The position serves as the Agency headquarters technical specialists in an area of analysis of foods, drugs, devices, instrumentation, pesticide residues, antibiotic residues, sterility, cosmetics, laboratory information technology and information systems, laboratory accreditation, etc.
WHO MAY APPLY: Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military spouses and individuals with disabilities.
YOU MUST SUBMIT YOUR SF-50 AND/OR DD FORM 214 OR YOUR APPLICATION WILL BE CONSIDERED INCOMPLETE.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to the selecting official as Commissioned Corps (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
LOCATION: This position is located in the Food and Drug Administration, Office of Regulatory Science (ORS), Office of Operations, Office of Regulatory Affairs (ORA), Office of Global Regulatory Operations and Policy located in Rockville, Maryland.
The salary listed in the vacancy announcement includes the geographical locality pay.
TYPE OF POSITION: This position is being filled on a full-time, permanent basis.
PROMOTION POTENTIAL: GS-13 is the full performance level.
Additional selections may be made from this announcement.
If selected for this position, you will:
- Serve as the reviewing authority on field guidance including compliance programs and field assignments in the specialized area.
- Plan, manage, and monitor field methodologies to develop new, improve, and validated methodology suitable for regulatory analysis, including food safety and defective applications.
- Monitor and evaluate field laboratory analytical capabilities and effectiveness of field laboratory staff to accomplish mission goals and operations.
- Review compliance programs in the specialized area, and prepares and/or modifies the instructions for the analytical accomplishment of the program.
- Serve as the focal point for day-to-day liaison between headquarters and the field facilities on scientific matters in their specialized area.
- Develop, implement and manage standard operating procedures for day-to-day operations for the ORS and field laboratories.
- Prepare, revise and/or edits appropriate laboratory manuals in the specialized area if unavailable, or if needed to be developed.
- Serve as the reviewing authority on technical laboratory issues involving State laboratories interacting with the Agency.
- Conduct laboratory quality assurance and quality control programs and practices, and develops standard operating procedures for laboratory operations in headquarters, the ORA field laboratories, and in District offices.
- Attend scientific meetings and discusses the significance and impact of regulatory analyses.