Careers

Quality Assurance Specialist

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 Quality Assurance (QA) Specialist is responsible for providing QA input and guidance for Manufacturing, Supply Chain, Quality, and R&D activities. Supporting the planning, management and radiochemical isotope manufacturing/filling processes including Batch Production review and assisting in other projects. This position could include PM hours and a weekend work schedule, this does include holidays, and flexibility in hours is needed.

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 and quality testing including batch records, test data, and receiving inspection. GDP and ALCOA Standard
  • Review and assess non-conformances; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
  • Review, approve and facilitate change controls including tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
  • Support remediation efforts to negative quality trends.

Qualifications

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and three to five years GMP related experience in biopharmaceutical/pharmaceutical or related industry with direct Quality experience; or equivalent combination of education and experience.  Familiarity of pharmaceutical manufacturing processes, 21CFR210/211/820/11.

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.

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.

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.

Quality Assurance Specialist – 1800 Gateway Blvd. Beloit, WI 53511