Position
This position is responsible for planning, managing, and supervising the activities of a Quality Control (QC) team. The QC Supervisor will provide oversight of staffing, lab policies, and quality procedures, ensuring that all processes from incoming material inspection through product release remain cGMP compliant and meet applicable regulatory standards.
Responsibilities
- Serve as the subject matter expert in selected areas of Quality Control.
- Provide on-the-floor QC oversight of manufacturing operations.
- Support and train Quality Control Specialists in component inspection, product testing, and laboratory analyses.
- Recruit, manage, and develop a team of quality specialists to ensure regulatory compliance and support NorthStar’s core values.
- Develop and implement new programs/processes to drive continuous improvement.
- Exhibit strong problem‑solving skills, taking initiative and focusing on achieving company goals.
Early Development
After 3 months you will:
- Be qualified to enter controlled spaces such as laboratories.
- Undergo training on ALARA principles and radiation safety.
- Provide support for routine manufacturing operations.
- Start training on final product testing and batch release processes.
After 6 months you will:
- Be qualified on analytical techniques and instrumentation.
- Be proficient in the majority of QC batch release activities.
- Support stability and product validation testing.
- Be qualified to provide training to other team members on certain QC functions.
Qualifications
Bachelor’s Degree in a scientific discipline and a minimum of four (4) years of experience in quality within the pharmaceutical, radiopharmaceutical, and/or medical device industry, with at least one (1) year of supervisory experience; or an equivalent combination of education and experience. Knowledge of ISPE standards and ASQ certification is preferred.
- Managing audits by regulatory agencies and customers.
- Direct interaction with regulatory agencies and customers.
- Execution of Quality Control testing and method implementation.
- Knowledge of regulations/standards/guidance (21 CFR 210 & 211, ICH Q7, Q8, Q9, Q10).
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, Tuesday, Wednesday, Thursday 1:30 pm – midnight (off on Fridays). During the 60‑day training period, the ability to work an alternate shift at least once is required. Primary shift placement will occur upon completion of training. This position supports production in a 24‑hour manufacturing facility, Monday to Friday, with occasional extended hours and holidays 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
- 401(k) match
- Paid holidays and paid time off (PTO)
- Paid parental leave
- Equity Incentive Program
Working Conditions
Physical demands include specific vision requirements such as near vision, visual acuity, and color discrimination.
This role may involve working in a controlled cleanroom environment, a general office setting, or specific manufacturing areas. Conditions may include:
- Exposure to varying temperatures, both indoors (heated/air‑conditioned spaces) and outdoors
- Noise levels ranging from quiet to loud, depending on the work area
- Specific vision abilities, including near vision, visual acuity, and color discrimination
Personal Protective Equipment (PPE)
- 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, and nail products, including polish, artificial nails, or extensions
Radiation Safety
- Follow strict radiation safety procedures
- Participate in dosimetry monitoring and bioassay testing as part of company protocol
- Inform leadership of any health conditions that may affect product integrity, in accordance with cleanroom standards
Location
NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant community that offers small‑city charm with the advantages of a central Midwest location. Beloit features a lively downtown with local restaurants, shops, and cultural events and is within a short drive of Madison, Milwaukee, Chicago, and Rockford. The region provides a blend of urban amenities and scenic natural surroundings, alongside opportunities for outdoor recreation, education, arts, and historic landmarks.
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 any other characteristic protected by law.