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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
United States - Nationwide
Fred Hutchinson Cancer Center
Multiple Locations, Washington
University of North Carolina Wilmington
Wilmington, North Carolina
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Radiopharmacy Quality Manager
Job SummaryReporting to the Radiopharmaceutical Sciences Manager, the Radiopharmacy Quality Assurance Manager is accountable for the comprehensive Quality Management Program within the Radiopharmaceutical Sciences (RPS). The Quality Assurance Manager is responsible for obtaining and maintaining a Drug Establishment Licence (DEL) and assisting in the generation of Clinical Trial Applications (CTA). This includes a radiopharmaceutical production program that meets Health Canada Good Manufacturing Practices (GMP) and staff safety program that meets Occupational Health & Safety, Radiation Safety, in conjunction with the Radiation Safety Officer and other applicable standards. The position is responsible for developing, implementing and auditing compliance with
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