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.
Who May Apply: This vacancy is open to current Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) employees with competitive status only. Competitive status refers to employees who are serving on a career or career conditional appointment.
Current FDA/ORA PHS Commissioned Corps 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.
YOU MUST SUBMIT YOUR SF-50.
LOCATION: This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Northeast Region, New York District. The position may be filled in any of the locations listed below. Location and salary will be determined upon selection.
Central Islip, NY
White Plains, NY
New Windsor, NY
Type of appointment: This is a permanent full time, career/career-conditional appointment.
This announcement may be used to fill multiple positions in multiple locations.
This position represents the highest level of expertise in a district office in areas which the inspection of licensed and unlicensed blood banks, manufacturers of source plasma and all processes utilizing phersis procedures, as well as human tissue and cellular tissue products. The incumbent is considered the primary expert who resolves the most difficult, controversial and complex inspectional problems involving scientific and regulatory biologic responsibilities in an area of expertise. Duties and responsibilities include:
· Plan, conduct and direct highly technical, complex and multi-faceted inspections and in-depth investigations in the area of blood banks and plasamapheresis programs, and human tissue and tissue based products.
· Make recommendations to regional and district management officials as to whether or not a firm/individual involved in the production, control and testing of blood bank, plasmapheresis or other biological product establishment, including human tissue and tissue based products is in compliance with Current Good Manufacturing Practices (CGMP) issues.
· Review reports of inspections and investigations for violations within the area of expertise including emergency situations, uncooperative industry officials, ambiguous or dubious evidence and lack of precedents and guidelines.
· Advise on new advances in technology related to biological products, including blood banks, plasmapheresis, human tissue, and tissue based products, new programs, laws and regulations, significant court decisions, and any new trends or scientific findings involving biologic programs.
· Serve on task forces and study groups charged with considering problems or directions in the area of biologics.
· Serve as an expert witness in area of expertise in court cases dealing with biologics relating to assigned area of expertise.