Quality Control Specialist; 2nd shift

North Star Medical Radioisotopes is a leading radiopharmaceutical company dedicated to advancing patient care through the development and supply of therapeutic radioisotopes and novel radiopharmaceuticals.

The primary role is to support quality activities related to the processing of radiopharmaceutical isotopes and radiologic science laboratories within the Quality Control team. Tasks include sampling, GMP laboratory testing, manufacturing support, and batch release testing of radioactive products. Extensive training on radiation safety, including ALARA principles, is required.

• Operate analytical instrumentation.
• Author and revise documents in the eQMS system.
• Train others on methods, procedures, and techniques as needed.
• Safely handle radioactive material, monitor dose, sample, aliquot, and perform contamination surveys.
• Perform and review receiving inspection tasks for release in the ERP system.
• Conduct environmental monitoring per applicable standards.
• Participate in document collaboration for manufacturing and quality testing (test data, protocols, reports, SOPs).
• Perform technical review of analytical data and lab logbooks.
• Execute microbiological, chemical, radio chemical, and stability testing.
• Initiate and approve non-conforming material reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations.
• Participate in multiple Project Teams and meetings.

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories.
• Receive training on ALARA principles and radiation safety.
• Perform basic environmental monitoring and receiving inspection techniques.
• Support site operational readiness.

After 6 months you will:

• Be qualified on advanced analytical techniques such as HPLC.
• Support final product testing and batch processes.
• Be qualified to provide training to other team members on certain QC functions.

Bachelor’s Degree in Chemistry, Biology, or related scientific discipline and a minimum of three (3) years of experience in a regulated industry (e.g., analytical instrumentation or prior laboratory experience); or equivalent combination of education and experience.

• Four (4) years of related experience in a cGMP environment and prior handling of radioactive materials.
• Understanding of pharmaceutical manufacturing processes and familiarity with batch production records (BPR) preferred.
• 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 must complete the Form I-9, Employment Eligibility Verification, on or before the first day of employment.

Second shift hours:
Monday – Thursday, 1:30 pm – midnight (off Fridays). During the initial 60‑day training period, the ability to work an alternate shift at least once is required. Primary shift placement occurs after training. This position also supports production in a 24‑hour manufacturing facility with occasional overtime and holidays.

Hourly shift premium: $5.00 per hour for hours worked between 6:00 pm and 6:00 am.

• 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

• Exposure to varying temperatures, both indoors and outdoors.
• Noise levels range from quiet to loud, depending on the work area.
• Specific vision abilities: near vision, visual acuity, and color discrimination.

• Respirators, gloves, safety glasses, and full protective clothing.
• Compliance with cleanroom gowning protocols (e.g., removal of jewelry, including piercings).
• Prohibition of cosmetics, fragrances, and nail products (clear nail polish, artificial nails, extensions).

• Follow strict radiation safety procedures.
• Participate in dosimetry monitoring and bioassay testing as part of company protocol.
• Report health conditions that may affect product integrity per cleanroom standards.

North Star Medical Radioisotopes – Beloit, Wisconsin. This position is eligible for a lump sum relocation benefit.

North Star 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.