**This announcement has been amended to remove the statement: " This announcement may be filled for multiple positions in multiple locations". If you have applied you do not need to reapply.
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This position is located in the Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). As an Interdisciplinary Scientist, you will be responsible for the evaluation of Current Good Manufacturing Practices (CGMPs) and/or drug applications and supplements associated with the manufacturing of human drug products.
This Job Opportunities Announcement will be open continuous for 90 days. The first cut-off date for applications received for consideration and/or referred to the hiring agency will be February 16, 2014. Subsequent referrals will be issued every 30 days (March 16, 2014, and April 16, 2014) until the announcement closes.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-14-1025536LB 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.
This job opportunity announcement may be used FDA-wide to fill additional vacancies within the same geographical location.
Performs administrative and scientific regulatory review for Current Good Manufacturing Practices (CGMP) of products and facilities and/or with drug applications, supplements, and amendments.
Provides advice and guidance within assigned product area to manufacturers, consumers, investigators, other reviewers, and agency committees on CGMPs on process validation, environmental issues and/or facility design.
Evaluates facility design, operation, manufacturing and testing procedures to ensure compliance with CGMP regulations and policies.
Meets with representatives of the regulated drug industry about potential product and establishment issues or scientific/regulatory issues involving drug products.