Supervisor, Quality Control (2nd shift)

NorthStar Medical Technologies; Beloit (WI); In loco; USD 95.000 - 125.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

FSA

Disability insurance

Life insurance

401(k) match

Paid time off

Parental leave

Equity incentive

Descrizione del lavoro

NorthStar Medical Radioisotopes in Beloit, Wisconsin, seeks a QC Supervisor to plan, manage, and supervise the QC team and ensure cGMP compliance from material inspection through product release.

The role requires a scientific degree with several years leading QC/QA in pharma or radiopharmaceuticals, plus experience with regulatory audits. Training on ALARA and RAD safety is included as part of growth in a fast‑growing field.

Competenze

• Bachelor’s Degree in a scientific discipline with 4–6 years QC/QA experience in pharma/radiopharma.
• Experience leading a team and interacting with regulatory agencies.
• Knowledge of ISPE standards; ASQ certification preferred.

Mansioni

• Oversee QC staff and on-the-floor QC activities for manufacturing operations.
• Support audits by regulators and customers and ensure compliance.
• Develop and implement continuous improvement programs within QC.
• Train QC Specialists in component inspection, product testing, and lab analyses.
• Ensure cGMP compliance from incoming materials to product release.

Conoscenze

Quality leadership

Regulatory audits

Laboratory oversight

Quality control testing

Formazione

Bachelor’s Degree in a scientific discipline

Descrizione del lavoro

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

This position is responsible for planning, managing, and supervising the activities of a Quality Control (QC) team. This role provides oversight of staffing, lab policies, and quality procedures. The QC Supervisor will provide quality control oversight and direction from incoming material inspection through product release to ensure quality processes are cGMP compliant and maintained. Projects and duties will be completed in compliance with applicable regulatory agency standards.

Responsibilities

• Serve as the subject matter expert in certain areas of Quality Control.
• Provide on-the-floor QC oversight of manufacturing operations.
• Provide support and training to Quality Control Specialists in respect to component inspection, product testing, and laboratory analyses.
• Recruit, manage, and develop a team of quality specialists to ensure compliance with the applicable regulations and support NorthStar’s Core Values.
• Develop and implement new programs/processes designed to drive continuous improvement.
• Exhibit strong problem solving skills, taking initiative, and focus on achieving company goals.

Early Development

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories
• Trained on ALARA principles and RAD 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 (6) years of experience in Quality in the pharmaceutical, radiopharmaceutical, and/or medical device industry with a minimum of one (1) year of experience leading others; or equivalent combination of education and experience. Knowledge of International Society for Pharmaceutical Engineering (ISPE) standards. American Society of Quality (ASQ) certification preferred.

Additional required experience includes:

• Managing audits by regulatory agencies and customers.
• Interacting directly with regulatory agencies and customers.
• Execution of Quality Control testing and methods.
• Knowledge of regulations/standards/guidance (specifically 21 CFR 210 & 211, ICH Q7, Q8, Q9, and 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 Tuesday, Wednesday, Thursday, Friday 1:30pm –midnight (off on Mondays). During this position’s training period (approximately 60 days), the ability to work an alternate shift at least once during the training period is required. Primary shift placement will occur upon completion of the training program. Additionally, this position supports production in a 24-hour manufacturing facility, Monday to Friday, occasional overtime and holidays required.

• 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 may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.

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)

• 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.

Please note that this position is eligible for a lump sum relocation benefit!

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.