Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Denver District Office located in Denver, CO.
The FDA's Office of Regulatory Affairs 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.
Who May Apply: Open to all United States Citizens.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-ORA-MP-13-872856 under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps (not as a career/career-conditional employee) are encouraged to apply under the merit promotion announcement indicated above.
This announcement may be used to fill multiple positions in multiple locations.
The incumbent will interact with counterpart State and local officials to help promote cohesive and uniform policies and activities in food and drug related matters and who will serve as liaison for information transfer between FDA and state, territorial, tribal, and local agencies. Develop, institute and coordinate all aspects of the District/State program including but not limited to: planning, coordinating, training, monitoring and auditing. Analyzes and evaluates the effectiveness of FDA District State program operations in meeting goals and objectives. Reviews state inspection reports for adequacy, prepares endorsements summaries of those reports and facilitates input into the IT system as needed.
Oversees state contracts within the District. Reviews state contract work in order to determine the acceptability of the work. Monitors the timeliness of state reports submissions and monitors the District's time frames. Monitors the state audit process to include scheduling the audits with the state, assigning the audit within the district, overseeing that the audits are performed and monitoring the audit classification (acceptable, needs improvement) in accordance with Field Management Directives.
Identifies, and ensures state and local officials are advised of, training opportunities. Designs instructional curricula and/or materials to address gaps and shortcomings. Ensures that the state training requirements have been met, and that the FDA auditors have also met the training requirements. Serves as the district's coordinator for providing training to new state employees on the e SAF system and provide ongoing training to current state employees on the eSAF system. Represents the District Office at State invited training, seminars and other State sponsored functions.