Job Overview

Summary

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 serves as the Imports Program Expert representing the highest level of expertise in a district for the inspection of FDA regulated imported products and commodities for compliance with FDA laws and regulations.  The Imports Program Expert is the primary source of expertise in an assigned area who resolves the most difficult, controversial and complete Imports inspectional problems which typically involve a combination of scientific and regulatory responsibilities. 

WHO MAY APPLY:  Current permanent (career/career-conditional appointments) employees of the Food and Drug Administration (FDA) only.  Current FDA employees serving under a Schedule A appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered.
 
YOU MUST SUBMIT YOUR SF-50.

FDA Commissioned Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement.  Candidates will be referred to (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 Affairs, Southwest Region, Southwest Import District Office.  Selections may be made in any of the four locations, Dallas, TX; Laredo, TX; San Diego, CA or Nogales, AZ. 

  
TYPE OF POSITION:  This position is being filled on a full-time, permanent basis.

PROMOTION POTENTIAL:  GS-13 is the full performance level.  

Salary range listed includes locality pay.

Duties

If selected for this position, you will:

 

·       Serve as a principle source of expertise and provide extensive advisory, liaison, and consultation services for the Import program.

·       Advise regulated industries, state agencies, and agency management on new advances in technology related to imports, new programs, laws and regulations and any new trends or scientific findings involving imports.

·       Establish, coordinate and review local and national initiatives in the import program.

·       Assure, through the independent development of recommended criteria for import screening, the national screening in MARCS (Mission Support and Regulatory Compliance Services) and PREDICT (Predictive Risk-Based Evaluation for Dynamic Import Compliance Tracking) is scientifically supportable and risk based. 

·       Review and provide comments on proposed Compliance Programs, assignments and local initiatives that reflect sound science, as well as knowledge of the growing, manufacturing, and transport processes used for the involved products and how it impacts public health.

·       Plan and monitor programs to completion in order to meet district program obligations using superior knowledge of industry.

·        Manage the review of previously approved products to determine whether they should continue to be permitted in light of current scientific safety criteria.

·        Serve on task forces and study groups charged with considering problems or directions in the area of expertise.

·        Evaluate the most complex manufacturing and warehousing operations against appropriate agency/Customs and Border Protection (CB) requirements.

·        Conduct investigations where the information is difficult to obtain and may be deliberately concealed or falsified and may involve contact with uncooperative industry personnel.

·        Review compliance history of a product or products on a national basis in order to recommend an opportunity for examination.

·        Develop, maintains and evaluates records of filler submissions through the PREDICT/MARCS systems.

·        Performs field examinations which represent the most in-depth, non-laboratory examination of a product and determines product compliance where no written guidance exists.

·        Develop and implements formal training programs for Agency personnel, industry and state/local officials and provides technical expertise to industry representatives. 

·        May serve as ad hoc team leader, responsible for planning, coordinating, and conducting field domestic, foreign and/or imports inspections/investigations.