Quality Control Specialist; 2nd Shift

Overview

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.

The primary role of this position is to provide support to various quality aspects associated with the processing of radiopharmaceutical isotopes and radiologic science laboratories within the Quality Control team. The role will focus on support activities, such as sampling, general GMP laboratory testing/support, manufacturing operations, and batch release testing of radioactive products. 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.

• Operate analytical instrumentation.
• Author and revise documents in the eQMS system.
• Train others on methods, procedures and techniques as required.
• Safely handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys.
• Perform and review receiving inspection tasks for release in the ERP system.
• Perform environmental monitoring in accordance with all applicable standards.
• Participate in DCO collaboration of documents in support of manufacturing and quality testing including 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 other meetings.

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories
• Trained on ALARA principles and RAD safety
• Be able to perform basic environmental monitoring and receiving inspection techniques
• Provide support to site operational readiness

After 6 months you will:

• Be qualified on more 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 other related scientific discipline and minimum three (3) years of experience in a regulated industry (e.g., analytical instrumentation / prior laboratory experience); or equivalent combination of education and experience. Preferred qualifications include:

• 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.