Quality Control Supervisor - Radiochemistry Operations
NorthStar Medical Radioisotopes, LLC
2021-12-03 11:30:03
Janesville, Wisconsin, United States
Job type: fulltime
Job industry: Science & Technology
Job description
Are you looking to be part of a game-changing organization that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team in Beloit, WI.
NorthStar develops, manufactures, and distributes radioisotopes used daily for patients needing medically important diagnostic imaging tests. Using novel and advanced technologies, NorthStar will scale-up production over the coming months and years and intends to become the industry's market leader.
Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.
Position
The primary role of this position is to provide support to various aspects of the radiopharmaceutical production process and radiologic science laboratories within the Quality Control team. The role will focus on support activities, such as sampling, general GMP laboratory testing/support, manufacturing operations, and batch release testing of radioactive products. This individual will ensure day-to-day laboratory functions are carried out by providing guidance, training, and support to other technicians and associates.
Duties will be completed in compliance with applicable cGMP, cGLP, FDA, and all other regulatory agencies standards.
Duties and Responsibilities
· Work with management to support customer and regulatory needs as it pertains to laboratory testing and manufacturing operations. This includes but is not limited to quality control testing, batch release testing, and annual stability testing.
· Provide support and training to Quality Control Specialists in respect to product testing and laboratory analyses.
· Provide on-the-floor QC oversight of manufacturing operations.
· Proficiently operate analytical instrumentation (i.e. scintillation counters, ICP-MS, IC). This may also include dose calibrators, survey meters, dosimetry monitors, and wipe test counters.
· Assist in review and approval of documents in support of manufacturing and quality testing including test data, protocols, reports, SOPs.
Qualifications
Bachelor's degree in a related science discipline, or completion of an accredited Nuclear Medicine Technology educational program, with 5 or more years of quality control laboratory experience and three or more years of supervisory experience. Previous experience handling radioactive materials preferred. Understanding of pharmaceutical manufacturing processes, 21 CFR 210/211/820 ideal.
Location
NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.
Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.
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.