Stony Brook University, home to many highly ranked graduate research programs, is located 60 miles from New York City on Long Island's scenic North Shore. Our 1,100-acre campus is home to 24,000 undergraduate, graduate, and doctoral students and more than 13,500 faculty and staff. The University is a member of the prestigious Association of American Universities and co-manager of nearby Brookhaven National Laboratory, a multidisciplinary research laboratory supporting world class scientific programs utilizing state-of-the-art facilities. Stony Brook Medicine is Suffolk County's only academic medical center and tertiary care provider. Many opportunities exist for collaborative research, and in some cases, joint appointments with BNL or with Medical School departments.
Descriptive Title: Quality Control Director
Budget Title: Director
Research Foundation Professional Position
RF Line#: TBD
Campus: Stony Brook West Campus/HSC
Salary: Commensurate with experience
Required Qualifications: Master's degree in Basic or Applied Science or a closely related field. Five years of full time experience in establishing and maintaining quality assurance for PET operations. Experience in keeping electronic records and laboratory information management systems (LIMS). Mastery of specialized techniques and ingenuity in selecting and evaluating approaches to unforeseen or novel problems. Progressively responsible related work experience including supporting complex scientific research programs, developing methods and standards for investigation and experimentation. Ability to perform assignments with a high level of efficiency.
Preferred Qualifications: PhD/Certificate in Radiopharmacy.
Brief Description of Duties: The primary purpose of the Quality Control Director is to conduct research, implement quality control measures, and to conduct investigations of any unacceptable quality control test results.
- Perform routine research and clinical radiotracer production for human and preclinical use.
- Instrument qualification, quality control for releasing tracer for human injection, and auditing of batch records.
- Responsible for confirming that the quality controls, production procedures, laboratory procedures, staff training, facilities, and equipment systems employed during the manufacturing and processing of Positron Emission Tomography (PET) drug products are in conformity with the PET Center's Standard Operating Procedures(SOPs) and in-turn with U.S. Pharmaceutical's compounding standards and official monograph for PET drugs as well as other FDA and applicable government standards.
- Conduct investigations of unacceptable quality control test results and document outcomes of investigations. Modify, as needed, all relevant SOPs or written procedures to implement corrections to prevent similar occurrences or the occurrence of other violations.
- Report to Scientific Staff, Group Leaders or Senior Scientific Associates.
- Correspond with the FDA and serve as the point person for inspections.
- If applicable, Radiopharmacist is responsible for clinical dose production.
Special Notes: This is a full-time position. The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA exempt position, not eligible for the overtime provisions of the FLSA. Internal and external search to occur simultaneously.
The selected candidate must successfully clear a background investigation.
Stony Brook University
- 2 years ago - save job