Radiopharmaceutical QC Specialist - Impactful Analytics

NorthStar Medical Technologies; Beloit (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

NorthStar Medical Radioisotopes is seeking a skilled scientist to operate analytical instrumentation and contribute to regulated radiopharmaceutical development. The role emphasizes documentation in an electronic quality management system and collaboration across teams to ensure data integrity in a GMP environment.

You will train colleagues on techniques, monitor radioactive materials safely, and support manufacturing, quality testing, and CAPA investigations.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related scientific discipline; 3+ years in a regulated industry (analytical instrumentation/lab).
• Preferred: 4+ years in a cGMP environment and handling radioactive materials.
• Understanding of pharmaceutical manufacturing processes; familiarity with batch production records (BPR).
• Familiarity with alpha, gamma, and beta spectroscopy is a plus.

Responsibilities

• Operate analytical instrumentation.
• Author and revise documents in the eQMS system.
• Train others on methods, procedures and techniques.
• Safely handle radioactive material and monitor dose.
• Perform receiving inspection tasks for ERP release.
• Conduct environmental monitoring per standards.
• Collaborate on document control and CAPA investigations.
• Review analytical data and lab logbooks.
• Conduct microbiological, chemical, radiochemical, and stability testing.
• Investigate deviations and non-conforming materials.”

Skills

Analytical instrumentation

Laboratory experience

Education

Bachelor's degree in Chemistry/Biology

Tools

eQMS

ERP system

Job description

NorthStar Medical Radioisotopes is seeking a skilled scientist to operate analytical instrumentation and contribute to regulated radiopharmaceutical development. The role emphasizes documentation in an electronic quality management system and collaboration across teams to ensure data integrity in a GMP environment.

You will train colleagues on techniques, monitor radioactive materials safely, and support manufacturing, quality testing, and CAPA investigations.