NorthStar Medical Radioisotopes, LLC

Quality Assurance Specialist (2nd Shift)

Job Locations US-WI-Beloit
ID
2025-2070
Category
Quality
Position Type
Regular Full-Time

Overview

Join the best radiopharmaceutical company in the world!

If you’re looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.

At the forefront of NorthStar’s technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. Our work is driven by a meaningful mission—advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package.

Position

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.

Responsibilities

  • Review and approve documents in support of manufacturing and quality testing including batch records, test data, and receiving inspection.
  • 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.
  • Interact with all departments to effectively implement and maintain Quality Systems.

Qualifications

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and minimum three (3) years of Quality Control or other related experience in a regulated industry; or equivalent combination of education and experience. 

 

Preferred qualifications include:

  • Four (4) years of related experience in a cGMP environment and previous experience handling radioactive materials.
  • Understanding of pharmaceutical manufacturing processes, and familiarity with batch production records (BPR) preferred. 
  • Familiarity with alpha, gamma, and beta spectroscopy is a plus.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.  Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment.  Under federal law, only truthful information may be provided on the Form I-9.

Shift Information

Second shift hours are Monday–Thursday, generally 1:00 p.m. to 12:00 a.m. (shift concludes early Friday morning). Actual daily hours may vary slightly depending on meal breaks.  During the training period (approximately 60 days), the ability to work 1st shift is required for the first 30 days, followed by flexibility to work varying shifts during the second 30 days. Primary shift placement will be assigned upon successful completion of the training program. This position supports production in a 24-hour, Monday–Friday manufacturing environment. As such, schedule flexibility, occasional extended hours, stand-by responsibilities, and holiday work may be required.

Benefits

  • Medical, dental, and vision insurance
  • Healthcare Flex Spending Account (FSA) and Dependent Care FSA
  • Company-paid short-term and long-term disability
  • Company-paid life insurance & AD&D coverage
  • Pet insurance
  • 401(k) match
  • Paid holidays and paid time off (PTO)
  • Paid parental leave
  • Bonus plan
  • Equity Incentive Program

Working Conditions

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:

  • Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
  • Noise levels range from quiet to loud, depending on the work area
  • Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

  • Respirators, gloves, safety glasses, and full protective clothing
  • Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
  • Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:

  • Follow strict radiation safety procedures
  • Participate in dosimetry monitoring and bioassay testing as part of the company protocol
  • Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

Location

NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.

Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you’re drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families 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.

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