Quality Assurance Specialist; 2nd Shift

Quality Assurance Specialist (2nd Shift)

Join to apply for the Quality Assurance Specialist (2nd Shift) role at North Star Medical Radioisotopes, LLC

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, North Star Medical Radioisotopes is the place to do it. North Star 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 North Star’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.

• Review and approve documents in support of manufacturing and quality testing including batch records, test data, and receiving inspection.
• Review and assess non‑conformances; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow‑up and reporting/trending.
• Review, approve and facilitate change controls including tracking, follow‑up, and reporting/trending and evaluating CAPA for effectiveness.
• Support remediation efforts to negative quality trends.
• Interact with all departments to effectively implement and maintain Quality Systems.

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and minimum three (3) years of Quality Control or other related experience in a regulated industry; or equivalent combination of education and experience.

• Four (4) years of related experience in a cGMP environment and previous experience handling 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 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.

Location:

Janesville, WI

Salary: $ - $

• Mid‑Senior level

• Full‑time

• Quality Assurance
• Pharmaceutical Manufacturing

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