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.

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 develop FDA-wide policy on compliance and enforcement.

 

This is an interdisciplinary position and may be filled in one of the following disciplines:

  • Biologist, GS-0401
  • Microbiologist, GS-0403 
  • Chemist, GS-1320

 

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; PHS Commissioned Corps Officers; and individuals with disabilities.

 

This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Pacific Regional Laboratory, Southwest (PRLSW), located in Irvine, CA.

 

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-ORA-DE-13-937373 under competitive procedures.  Please review that announcement to see if you are eligible for consideration under competitive procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.


This announcement may be used to fill multiple positions in multiple locations.

Duties

The incumbent will work under the direction of the Quality Assurance Manager who is responsible for the development and maintenance of a quality control/assurance program that assures quality work products and offers clear guidelines and quality standards. Reviews and evaluates the results of analyses conducted under these quality assurance programs.  Evaluate quality assurance programs and the results of quality assurance reviews.  Based on reviews, makes recommendations within the Laboratory District on instrumentation and other technical modifications, as well as changes to existing quality assurance programs.  Prepares summaries and reports addressing such areas as problems and deficiencies, corrective actions taken, and recommendations for strengthening and improving programs.  Works closely with Laboratory District Management and the Quality System Manager in guiding, coordinating, and monitoring the overall quality of work products and management systems.  Interpret the general requirements of the the International Standard for Quality Systems (ISO-17025:2005) to evaluate competence of testing and calibration laboratories, to include sampling, using standard, non-standard, and laboratory-developed methods.