Medical Isotope Quality Representative

Overview: 

Oak Ridge National Laboratory is the largest US Department of Energy science and energy laboratory, conducting basic and applied research to deliver transformative solutions to compelling problems in energy and security.

We are seeking a Medical Isotope Senior Quality Assurance Representative to lead the quality team for a project that produces a medical isotope under current Good Manufacturing Practice (cGMP) controls.

The Isotope Program (IP) at ORNL produces and purifies radionuclides for medical and industrial applications as well as for fundamental research. This isotope is currently being utilized in multiple clinical trials as a therapeutic agent in the treatment of various cancers.  The isotope is offered for distribution through the DOE Isotope Program as part of their isotope portfolio. The successful candidate will maintain and continue to improve the existing quality program to address the compliance needs of cutting-edge Active Pharmaceutical Ingredients used in medical radiopharmaceuticals.

The Quality Representative ensures that the radioisotope intended for use as an Active Pharmaceutical Ingredient (API) is produced under appropriate controls and facility environments.

Major Duties/Responsibilities: 

• Interpret quality assurance requirements provided in 21 CFR 211 and ICH Q7 and determine appropriate application in work procedures and documents
• Review production batch records and perform final approval for release of radioisotope products for distribution
• Assist in development of technical procedures and documents, and assess for implementation of QA requirements
• Oversee and evaluate planned change controls for changes to the process, equipment, facilities, etc
• Maintain up-to-date filings with the Food and Drug Administration and other regulatory agencies, including maintenance of a Drug Master File
• Lead cGMP training for the program

Basic Qualifications:

• An Bachelor’s Degree in Science, Quality Assurance, or a related field and a minimum of 5 years experience. A combination of education and experience may also be considered
• Advanced knowledge of current Good Manufacturing Practice (cGMP) for drug manufacturing
• Advanced knowledge of and experience with quality assurance activities including supporting regulatory, customer, and performance audits, investigating non-conformances and deviations, recommending and implementing corrective actions, providing complete and accurate documentation of quality activities through technical reports, and ensuring quality assurance compliance
• Experience developing and managing document change control systems and performing necessary evaluations of proposed changes against regulatory filings and requirements.
• Experience successfully collaborating with internal and external organizations
• Experience with quality oversight of drug manufacturing (e.g., approval of production records, process validation, etc.)
• Demonstrated experience in providing quality support to a technical organization
• Understand the basics of radioactive decay

Preferred Qualifications:

• Experience with quality related aspects of analytical methods including gamma spectroscopy, inductively coupled plasma spectroscopy or similar analytical techniques
• Experience with radioisotope production
• Experience with new facility design and environmental controls for manufacturing
• Experience with radioactive decay calculations
• Excellent written and oral communication skills
• Motivated self-starter with the ability to work independently and to participate creatively in collaborative teams across the laboratory 
• Ability to function well in a fast-paced research environment, set priorities to accomplish multiple tasks within deadlines, and adapt to ever changing needs

Moving can be overwhelming and expensive. UT-Battelle offers a generous relocation package to ease the transition process. Domestic and international relocation assistance is available for certain positions. If invited to interview, be sure to ask your Recruiter (Talent Acquisition Partner) for details.

For more information about our benefits, working here, and living here, visit the “About” tab at jobs.ornl.gov.