Quality Control Specialist (1st shift)

About the role

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. We are driven by a meaningful mission—advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need.

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, 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, 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

Qualifications

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
• Previous experience handling radioactive materials
• Understanding of pharmaceutical manufacturing processes, and familiarity with batch production records (BPR)
• Familiarity with alpha, gamma, and beta spectroscopy

Additional Information

Please note the company cannot provide immigration-related sponsorship 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.