Senior QC Lead — Radiopharmaceuticals & Analytics

NorthStar Medical Technologies; Beloit (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

NorthStar Medical Radioisotopes is seeking a senior QC leader to oversee analytical instrumentation and quality control in a regulated setting. The role emphasizes safety, data integrity, and timely communication of issues within a fast-growing radiopharmaceutical environment.

The candidate will train QC staff, manage validation transfers, and support audits while maintaining ISO-compliant practices across operations.

Qualifications

• Bachelor’s Degree in Chemistry, Biology, or related discipline.
• Minimum nine (9) years of experience in a regulated industry.
• Experience handling radioactive materials preferred.
• Familiarity with cGMP environments.

Responsibilities

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Lead, coordinate, and communicate QC Team responsibilities and activities.
• Provide on the job training for QC team and assist in trouble shooting analytical instruments.
• Proficiently operate analytical instrumentation.
• Perform company-wide training and facilitate training program for QC personnel on industry best practices for ISO controlled environments.
• Author, review, and approve quality test data, protocols, reports, SOPs.
• Assist with the transfer of validation activities of Quality Control (QC) test methods.
• Serve as the subject matter expert in analytical instrumentation.
• Participate independently as the lead on multiple projects and meetings.
• Support the department manager and/or designee in their absence.
• Initiate and approve non-conforming materials reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations.
• Participate in internal assessments and regulatory audits as required.

Skills

Quality Control

Analytical Instrumentation

Training

Regulated Industry

Education

Bachelor's Degree in Chemistry, Biology, or related scientific discipline

9+ years of experience in a regulated industry

Tools

Spectroscopy (alpha/gamma/beta)

Job description

NorthStar Medical Radioisotopes is seeking a senior QC leader to oversee analytical instrumentation and quality control in a regulated setting. The role emphasizes safety, data integrity, and timely communication of issues within a fast-growing radiopharmaceutical environment.

The candidate will train QC staff, manage validation transfers, and support audits while maintaining ISO-compliant practices across operations.