Quality Assurance Specialist
About The Position
The Corporate Quality Assurance Specialist provides Quality oversight for the Production Support Lab, Technical Support Team, and Implementation Team. These corporate teams support U.S. sites that manufacture and distribute radioactive sterile injectables (PET) under 21 CFR Part 212 and USP 825. The specialist acts as the Quality System Officer (QSO) for the teams and supports Radiopharma’s Quality oversight functions. The role supports root cause and trend analyses of technical issues, including analytical equipment and manufacturing-related issues, and reviews GMP investigations, CAPAs, and change controls for technical accuracy. It also serves as a subject matter expert on assigned topics, contributes to policies and procedures, and participates in continuous improvement and trend-analysis projects. Additional work includes reviewing qualifications and other documentation, providing GMP training to corporate personnel, and supporting audits and inspections. This is an onsite position based in Knoxville, Tennessee, with travel of approximately 10%.
Requirements
- At least 3 years of experience manufacturing radiopharmaceuticals.
- At least 3 years of experience performing QC testing of radiopharmaceuticals.
- Experience with pharmaceutical industry work, preferably sterile drug manufacturing, and/or PET radiopharmaceuticals under 21 CFR Part 212 and Part 11 and/or USP 825.
- Experience in Quality Assurance disciplines, including problem-solving, root cause analysis, investigation writing, and management of corrective and preventive actions.
- Ability to identify procedural gaps and product risk and, where appropriate, recommend contingency plans and compliance-mitigation strategies.
- Ability to coordinate across departments to keep tasks on track and maintain compliance.
- Bachelor’s degree in a scientific field such as biology, chemistry, microbiology, or pharmacy, or equivalent experience.
- Excellent attention to detail and ability to manage a schedule efficiently and complete responsibilities accurately and on time.
- Creative problem-solving skills and ability to reprioritize multiple times per day while delivering results on time.
- Good PC skills, including Microsoft Word, PowerPoint, Excel, and Outlook.
- Willingness to travel approximately 10% and be flexible.
Nice To Haves
- Studies in Microbiology and/or Analytical Chemistry, or a similar technical discipline.
- Experience in sterile drug manufacturing.
Responsibilities
- Provide Quality oversight of the Production Support Lab, Technical Support Team, and Implementation Team.
- Act as the Quality System Officer (QSO) for the listed corporate teams.
- Assist with root cause analysis and trend analysis of technical issues, including analytical equipment and manufacturing-related issues, to support GMP investigations and CAPAs.
- Review assigned GMP-related investigations, CAPAs, and change controls to ensure technical components are accurate.
- Serve as a subject matter expert on assigned topics and provide input on related policies, procedures, and decisions.
- Participate in assigned continuous improvement and trend-analysis projects.
- Review qualifications and other documentation.
- Provide GMP training to corporate personnel as needed.
- Support audits and inspections for Radiopharma Quality oversight functions.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan
- Life insurance
- Long-term and short-term disability insurance
- Paid parking/public transportation
- Paid time off
- Paid sick and safe time
- Flexible and dynamic work environment
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
