Quality Control Supervisor
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. NorthStar is 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 the Mo-99 is 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 which 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 Control (QC) Supervisor is responsible for providing oversight for the company’s day to day compliance with applicable domestic and international regulations and standards so that product distribution to the desired markets is realized. The QC Supervisor will be responsible for ensuring that cGMP compliant quality processes within Quality Control are maintained.
Duties and Responsibilities
- Direct the NorthStar (NS) – Columbia daily QC functions by maintaining internal QC and site systems to meet site needs while ensuring adherence to Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and other regulatory requirements.
- Direct the review of documentation including but not limited to Procedures, Batch Production Records, Equipment Qualifications Protocols, Analytical Method Validation, Process Validation Protocols, and Nonconformity/Deviations/Events/OOS.
- Assist in the development of QC plans by identifying critical control points and preventive measures, monitoring adherence to procedures, and implementing corrective actions and verification procedures.
- Assist with regulatory audits.
- Bachelor’s Degree in Chemistry, Biology or other related scientific discipline and three or more years of Quality experience within the pharmaceutical industry and a minimum of two years of supervisory experience preferred; or equivalent combination of education and experience.
- Experience working directly with regulatory agencies, sound knowledge of applicable portions of agency guidance’s, and regulations (21CFR Part 210/211/820). Experience with radiopharmaceuticals preferred.
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 Control Supervisor – 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.