GMP Quality Assurance Specialist – Radiopharma

NorthStar Medical Technologies; Beloit (WI); On-site; USD 70,000 - 110,000; Full time

Job summary

NorthStar Medical Radioisotopes in Beloit, WI, seeks a Quality Assurance professional to ensure GMP-compliant manufacturing and documentation in a fast-growing radiopharmaceutical environment. You will help maintain product quality and regulatory readiness across complex processes.

The role focuses on reviewing records, approving CoA for final releases, supporting CAPAs, and driving continuous improvement within the eQMS to sustain patient safety and supply reliability.

Qualifications

• Bachelor’s Degree in Chemistry, Biology, or related field with GMP experience.
• Minimum three years of GMP-related experience in biopharma or regulated industry.
• Immigration sponsorship not provided; Form I-9 completion required.

Responsibilities

• Review and approve production records to ensure GMP compliance.
• Review and approve documentation supporting manufacturing and quality processes.
• Approve Certificate of Analysis (CoA) activities for final product release and shipment.
• Review environmental monitoring data and calibration certifications.
• Develop and improve quality system processes.
• Train team members on quality system requirements.

Skills

GMP knowledge

Quality Assurance

Documentation

Audit experience

Education

Bachelor’s Degree in Chemistry, Biology

Tools

eQMS experience

Job description

NorthStar Medical Radioisotopes in Beloit, WI, seeks a Quality Assurance professional to ensure GMP-compliant manufacturing and documentation in a fast-growing radiopharmaceutical environment. You will help maintain product quality and regulatory readiness across complex processes.

The role focuses on reviewing records, approving CoA for final releases, supporting CAPAs, and driving continuous improvement within the eQMS to sustain patient safety and supply reliability.