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 is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), New England District Office located in either Stoneham, MA, Hartford, CT or Calais, ME.

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.

Who May Apply:  Open to all United States Citizens.

Salary Range indicated above reflects the following duty locations: Calais, ME, $31,315-$61,678 Stoneham, MA, $34,234-$67,427 Hartford, CT, $34,514-$67,978  

This announcement may be used to fill additional vacancies.

Duties

The incumbent will conduct inspections and investigations of facilities that are routine utilizing current FDA instructions, agency policies regulations.  Survey and conduct follow-up with non-compliant industry establishments for compliance.  Analyze and evaluate data samples, various other documentation gathered during inspection or investigation.  Inspections cover all the types of products and problems within the area of assigned responsibility.  Investigates and evaluates the adequacy of manufacturing practices to determine compliance with FDA laws and regulations. Analyze results, decides when an investigation is complete or what additional work may be required. Participate in court hearings as necessary.