Quality Assurance Specialist
Are you looking to be part of something extraordinary and meaningful that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking motivated individuals like you to join our rapidly growing team in Columbia, MO. Innovative technology, Opportunities for career advancement, and competitive compensation are just the beginning at NorthStar. In addition to health and life insurance, paid holidays, and paid time off, all NorthStar employees are eligible on Day One for our annual bonus and equity incentive plans.
NorthStar develops, manufactures and distributes radioisotopes that are used daily for patients needing medically important diagnostic imaging tests. Our novel, high technology approaches have enabled NorthStar to be the first company in nearly 30 years to produce the radioisotope Mo-99 in the United States. NorthStar’s processes are non-uranium based and designed to help minimize waste while meeting the highest quality standards. The Mo-99 is used in NorthStar’s RadioGenix® System, an isotope separation platform used by radiopharmacies across the country to produce the imaging radioisotope Tc-99m. NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader. Beyond Mo-99, we have a pipeline of other novel and medically important isotopes that can further grow our business and provide development opportunities for our employees. Working with this novel and advanced technology is challenging yet rewarding for talented individuals who want to make a difference and be part of an exciting and rapidly growing business. NorthStar’s people drive our solutions and our success, and we are committed to ensuring that we provide fulfilling work experiences and valuable development opportunities.
The Quality Assurance (QA) Specialist is responsible for providing QA input and guidance for Manufacturing, Supply Chain, Quality, and R&D activities. The QA Specialist will perform all responsibilities in accordance with company policies, procedures, global regulations, and safety requirements.
Duties and Responsibilities
- Review and approve documents in support of manufacturing, engineering, validation, and quality testing including batch records, test data, and receiving inspection.
- Review and assess non-conformances, out of specifications, deviations, CAPA’s, and perform root cause analysis.
- Support creation and review of standard operating procedures, work instructions, protocols, batch records, and reports.
- Ensure operations compliance to standard operating procedures and work instructions by providing on-the-floor QA oversight of manufacturing operations.
- Bachelor’s Degree in a scientific discipline.
- Two to five years GMP related experience in biopharmaceutical, pharmaceutical or other regulated industry, direct Quality experience; or equivalent combination of education and experience.
- Familiarity with pharmaceutical manufacturing processes, 21CFR Parts 210, 211, 820, 11.
Location – Columbia, MO
NorthStar’s isotope production employees are based in Columbia, Mo. Our administrative offices are at the recently opened Missouri Innovation Center, and the team operates state-of-the-art processing equipment in the NorthStar Isotope Production suites at the Missouri University Research Reactor Campus, just a short walk away. From picturesque parks and clever cuisine to amazing art and superb shopping, visitors find that Columbia is more than a college town – it is a vibrant and sophisticated city.
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.
Quality Assurance Specialist – Columbia, MO
NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law.