Quality Control Specialist (2nd Shift)

About the role

Join a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. At NorthStar Medical Radioisotopes, you’ll operate at the forefront of scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. This role offers exceptional career growth and professional development opportunities in a specialized, fast-growing field.

Responsibilities

• Operate analytical instrumentation.
• Author and revise documents in the eQMS system.
• Train others on methods, procedures, and techniques as required.
• Safely handle radioactive material, including 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, and SOPs.
• Perform technical review of analytical data and lab logbooks.
• Execute microbiological, chemical, radiochemical, 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.

Requirements

• 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: 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.

Benefits

A competitive benefits package is offered, supported by world-class facilities.