Quality Control Scientist – Radiopharmaceuticals & Analytics

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

Job summary

NorthStar Medical Radioisotopes seeks an experienced scientist to operate analytical instruments, document in the eQMS, and train colleagues. The role involves safe handling of radioactive materials, environmental monitoring, and collaboration on manufacturing quality tests.

You will review data, perform stability testing, and participate in CAPA investigations and cross‑functional project teams in a regulated, growth‑oriented setting.

Qualifications

• Bachelor’s Degree in Chemistry, Biology, or related scientific discipline and minimum three (3) years of experience in a regulated industry; or equivalent combination of education and experience.
• Preferred: Four (4) years of related experience in a cGMP environment and handling radioactive materials.
• Understanding of pharmaceutical manufacturing processes; familiarity with batch production records (BPR) preferred.
• 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 as required.
• Safely handle radioactive material, monitor radioactive dose, sample, aliquot and perform contamination surveys.
• Perform and review receiving inspection tasks for release in the ERP system.
• Perform environmental monitoring in accordance with applicable standards.
• Participate in DCO collaboration of documents to support manufacturing and quality testing.
• Perform technical review of analytical data and lab logbooks.
• Execute microbiological, chemical, radiochemical, and stability testing.
• Initiate and approve non‑conforming material reports and investigate deviations and CAPA investigations.
• Participate in Project Teams and other meetings.

Skills

Analytical instrumentation

Documentation in eQMS

Laboratory techniques

Quality compliance

Education

Bachelor's degree in Chemistry/Biology or related science

Experience in regulated industry (3+ years)

Tools

eQMS system

ERP system

Job description

NorthStar Medical Radioisotopes seeks an experienced scientist to operate analytical instruments, document in the eQMS, and train colleagues. The role involves safe handling of radioactive materials, environmental monitoring, and collaboration on manufacturing quality tests.

You will review data, perform stability testing, and participate in CAPA investigations and cross‑functional project teams in a regulated, growth‑oriented setting.