Quality Control Lead

NorthStar Medical Radioisotopes • Beloit, WI

1d • Onsite

About The Position

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, 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.
The 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.

Requirements

• Bachelor’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.
• 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.

Nice To Haves

• Previous experience handling radioactive materials preferred.
• Familiarity with alpha, gamma, and beta spectroscopy is a plus.

Responsibilities

• Effectively 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.

Benefits

• 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
• Pet insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Bonus plan
• Equity Incentive Program
• Relocation assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior