Quality Control Lead

About the role

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 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.

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 troubleshooting analytical instruments.
• Proficiently operate analytical instrumentation.
• Perform company-wide training and facilitate training programs for QC personnel on industry best practices for ISO controlled environments.
• Author, review, and approve quality test data, protocols, reports, and 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.

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.