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.
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
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
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.
This position will remain open for a minimum of 5 days after which it will close when a qualified candidate is identified and/or hired.
We accept Word (.doc, .docx), Adobe (unsecured .pdf), Rich Text Format (.rtf), and HTML (.htm, .html) up to 5MB in size. Resumes from third party vendors will not be accepted; these resumes will be deleted and the candidates submitted will not be considered for employment.
Oak Ridge National Laboratory (ORNL) delivers scientific discoveries and technical breakthroughs needed to realize solutions in energy and national security and provide economic benefit to the nation. We address national needs through impactful research and world-leading research centers. Our wide range of partnerships with other US Department of Energy (DOE) laboratories and programs, universities, and industry allows us to pair our strengths with others for outstanding contributions to science.