Supervisor, Quality Control (2nd shift)
OverviewJoin 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.PositionThis 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.ResponsibilitiesServe 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 DevelopmentAfter 3 months you will:Be qualified to enter controlled spaces such as laboratoriesTrained on ALARA principles and RAD safetyProvide support for routine manufacturing operationsStart training on final product testing and batch release processes After 6 months you will: Be qualified on analytical techniques and instrumentationBe proficient in the majority of QC batch release activitiesSupport stability and product validation testingBe qualified to provide training to other team members on certain QC functionsQualificationsBachelor's Degree in a scientific discipline and a minimum of four (4) 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 InformationSecond shift hours are Monday, Tuesday, Wednesday, Thursday 1:30pm -midnight (off on Fridays). 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 extended hours and holidays required.BenefitsMedical, dental, and vision insuranceHealthcare Flex Spending Account (FSA) and Dependent Care FSACompany-paid short-term and long-term disabilityCompany-paid life insurance & AD&D coveragePet insurance401(k) matchPaid holidays and paid time off (PTO)Paid parental leaveBonus planEquity Incentive ProgramWorking ConditionsPhysical 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 outdoorsNoise levels range from quiet to loud, depending on the work areaSpecific 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 clothingCompliance 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 extensionsAs 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 proceduresParticipate in dosimetry monitoring and bioassay testing as part of the company protocolInform leadership of any health conditions that may affect product integrity, by cleanroom standardsLocationNorthStar 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!