Quality Control Lead

NorthStar Medical Radioisotopes PositionThe primary role of this position is to conduct and validate various biological and analytical quality control assays associated with the processing of radiopharmaceutical isotopes and drugs to ensure compliance with established standards. This role requires extensive training on radiation safety including ALARA ("as low as reasonably achievable") principles.Projects and duties will be completed in compliance with applicable regulatory agency standards.This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required. Early morning, late evening, weekend, and some holiday work will be required with occasional overtime.ResponsibilitiesEffectively communicate safety and quality issues raised by customers or staff in a timely manner.Lead, coordinate, and communicate QC Team responsibilities and activities.Provide on the job training for QC team and assist in trouble shooting analytical instruments.Proficiently operate analytical instrumentation.Perform company-wide training and facilitate training program for QC personnel on industry best practices for ISO controlled environments.Author, review, and approve quality test data, protocols, reports, SOPs.Assist with the transfer of validation activities of Quality Control (QC) test methods.Serve as the subject matter expert in analytical instrumentation.Participate independently as the lead on multiple projects and meetings.Support the department manager and/or designee in their absence.Initiate and approve non-conforming materials reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations. Perform risk assessments, participate in root cause analysis investigations, tracking, follow-up, and reporting/trending.Participate in internal assessments and regulatory audits as required.Early DevelopmentAfter 3 months you will:Be qualified to enter controlled spaces such as laboratoriesTrained on ALARA principles and RAD safetyProvide support to site operational readinessStart training on final product testing and batch processesAfter 6 months you will:Be qualified on more advanced analytical techniques such as HPLCBe proficient in the majority of QC batch release activitiesSupport tech transfer, stability, and product validation testingBe qualified to provide training to other team members on certain QC functionsQualificationsBachelor's Degree in Chemistry, Biology, or other related scientific discipline and minimum nine (9) years of experience in a regulated industry; or equivalent combination of education and experience. Preferred qualifications include:Nine (9) years of related experience in a cGMP environment and previous experience handling radioactive materials preferred.Understanding of pharmaceutical manufacturing processes.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 Information1st Shift: This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required. Early morning, late evening, weekend, and some holiday work will be required with occasional overtime.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 discriminationPersonal 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!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.