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.