Radiopharma QA Specialist — GMP, Audits & Compliance

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) match

Paid holidays and PTO

Bonus plan

Equity Incentive Program

Relocation benefit

Job summary

NorthStar Medical Radioisotopes in Beloit, Wisconsin, is seeking a QA Specialist to support manufacturing and quality operations. You will maintain quality systems, ensure GMP/GLP compliance, review production records, and collaborate across teams to uphold quality standards.

The role involves on-floor QA oversight, investigations, audits, and continuous improvement of quality processes, with shifts in a 24-hour facility and relocation benefits available.

Qualifications

• Bachelor’s degree in a scientific discipline with GMP-related experience.
• Experience reviewing production records and documentation for GMP compliance.
• Ability to lead investigations and support CAPA activities.

Responsibilities

• Review and approve production records (electronic and paper) for GMP compliance.
• Review and approve documentation supporting manufacturing and quality system processes.
• Approve CoA activities for final product release and shipment.
• Review environmental monitoring data, media fills, gowning qualifications, and calibration certifications.
• Review controlled documents and assist with eQMS document management.
• Support development and continuous improvement of quality system processes.
• Initiate and investigate nonconformances and deviations; lead root cause analyses.
• Participate in internal and regulatory audits; lead internal audits as assigned.
• Train team members on job functions and quality system requirements.
• Create and report departmental quality metrics; support new process implementations.

Skills

GMP experience

QA oversight

Documentation

Audit support

Education

Bachelor’s Degree in Chemistry/Biology or related field

Job description

NorthStar Medical Radioisotopes in Beloit, Wisconsin, is seeking a QA Specialist to support manufacturing and quality operations. You will maintain quality systems, ensure GMP/GLP compliance, review production records, and collaborate across teams to uphold quality standards.

The role involves on-floor QA oversight, investigations, audits, and continuous improvement of quality processes, with shifts in a 24-hour facility and relocation benefits available.