Join the team as a Quality Control Specialist at NorthStar Medical Radioisotopes in Beloit, WI.
As a Quality Control Specialist, you will support various quality functions related to radiopharmaceutical isotope processing and laboratory operations. This includes sampling, GMP lab testing, manufacturing support, and batch release testing of radioactive products. You'll play a critical role in ensuring compliance with all applicable regulatory requirements while upholding the highest standards of safety and quality in a highly specialized, collaborative environment.
NorthStar Medical Radioisotopes seeks individuals who desire to work within the pharmaceutical industry who, possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner.
Benefits
- Access to innovative technology
- Opportunities for career advancement
- Competitive compensation
- Health and life insurance
- 401(k) match
- Paid holidays and paid time off (PTO)
- Paid parental leave
- Eligibility on day one for annual bonus and equity incentive plans
Shift Information
This position supports a 24-hour manufacturing facility; schedule includes weekday time off when weekend work is requiredEarly morning, late evening, weekend, and some holiday work will be requiredOccasional overtime may be necessaryRequired Education and Experience
Bachelor's Degree in Chemistry, Biology, or a related scientific discipline AND3+ years of experience in a regulated industry, OREquivalent combination of education and experiencePreferred Experience
4+ years in a cGMP environmentExperience handling radioactive materialsFamiliarity with pharmaceutical manufacturing processes and batch production recordsExperience with alpha, gamma, or beta spectroscopyEssential Functions
Operate analytical instrumentationAuthor and revise documents within the eQMS systemTrain team members on methods, procedures, and techniques as requiredSafely handle radioactive materials, including dose monitoring, sampling, aliquoting, and contamination surveysPerform and review receiving inspection tasks for material release in the ERP systemConduct environmental monitoring in accordance with applicable standardsCollaborate on DCOs related to manufacturing and quality testing documents, including test data, protocols, reports, and SOPsReview analytical data and laboratory logbooks for technical accuracyPerform microbiological, chemical, radiochemical, and stability testingInitiate and approve non-conforming material reports (NCMRs); investigate deviations, laboratory out-of-specification (OOS) results, and CAPA eventsParticipate in project teams and other assigned meetingsWorking Conditions
Work takes place in indoor office, cleanroom, and manufacturing environments with exposure to varying temperatures and noise levelsPPE is mandatory, including respirators, gloves, safety glasses, and full-body protectionEmployees must comply with cleanroom policies, including restrictions on jewelry, cosmetics, nail products, and fragranced itemsWork may involve radiation exposure; dosimetry and bioassay testing are requiredPhysical Demands
Specific vision abilities required, including near vision / acuity and color discriminationMust be able to perform tasks requiring manual dexterity and attention to detailGeneral Requirements
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 must 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.