QA Operations Leader — GMP Radiopharma

NorthStar Medical Radioisotopes; Beloit (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) match

Paid holidays and PTO

Bonus plan

Equity Incentive Program

Job summary

NorthStar Medical Radioisotopes in Beloit, Wisconsin, seeks a Quality Assurance Operations Supervisor to lead daily QA activities, ensuring GMP compliance and adherence to company quality standards. You will oversee the QA team, manage investigations, CAPA, and change controls, and drive a culture of quality and continuous improvement.

The role emphasizes staff training, performance evaluations, audit readiness, and support for inspections, with opportunities for professional growth in a rapidly

Qualifications

• Bachelor’s degree in chemistry, biology, or related science with ≥6 years GMP‑related QA experience; 1 year of leadership.
• Working knowledge of 21 CFR Parts 210, 211, and 11, and ICH guidelines.
• Experience supervising QA personnel in a regulated GMP manufacturing environment.
• Experience leading investigations, CAPAs, change controls, and audit activities.
• ASQ certification preferred.

Responsibilities

• Communicate safety and quality issues promptly.
• Lead day‑to‑day QA operations and team activities.
• Coach and develop QA staff to ensure compliance and performance expectations.
• Monitor adherence to GMP requirements, quality systems, procedures, and applicable regulations.
• Oversee investigations, CAPAs, change controls, and audit readiness.
• Support inspections and drive process improvements and efficiency.
• Coordinate with QA Operations to enable cost‑effective development programs.

Skills

Leadership

Quality Assurance

Investigations

CAPA

Risk Management

Education

Bachelor's degree in chemistry, biology, or related

Job description

NorthStar Medical Radioisotopes in Beloit, Wisconsin, seeks a Quality Assurance Operations Supervisor to lead daily QA activities, ensuring GMP compliance and adherence to company quality standards. You will oversee the QA team, manage investigations, CAPA, and change controls, and drive a culture of quality and continuous improvement.

The role emphasizes staff training, performance evaluations, audit readiness, and support for inspections, with opportunities for professional growth in a rapidly