Senior 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 Beloit, WI. 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 Senior Quality Assurance (QA) Specialist is responsible for providing QA input and guidance for Manufacturing, Supply Chain, Quality, and R&D activities. The Senior QA Specialist will perform all responsibilities in accordance with company policies, procedures, global regulations and safety requirements.
Duties and Responsibilities
- Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends including production processes, environmental monitoring data, CAPA, Deviations, OOS data, and validation information. Report quality metrics to Manager, Quality Assurance.
- Provide on-the-floor QA oversight of manufacturing operations.
- Assist with the resolution of product/assembly issues in Operations/Manufacturing, through coordination of investigations, submitting and/or initiating Events/Deviations/OOS, or CARs & SCARs, recommending customer bulletins, etc.
- Organize data and prepare appropriate documentation for assigned projects in the areas of equipment, software, process, cleaning, control system and critical system validation.
- Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and five or more years GMP related experience in biopharmaceutical/pharmaceutical or related industry with direct Quality experience; or equivalent combination of education and experience.
- Familiarity with pharmaceutical manufacturing processes, 21CFR210/211/820/11.
Location – Beloit
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.
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.
Senior Quality Assurance Specialist – 1800 Gateway Blvd. Beloit, WI 53511
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.