Careers Northstarnm.icims.com
Supervisor, Quality Assurance – Operations (2nd shift)
Beloit, WI, US
Work authorization requiredDetected 1 day ago
AuditingPatient CareGMPLeadershipMentoringInternal AuditLean Manufacturing
About the role
- Overview Join the best radiopharmaceutical company in the world!
- NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer.
- The supervisor is responsible for training, coaching, and evaluating staff while promoting a culture of quality and continuous improvement.
Responsibilities
- Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.
- At the forefront of NorthStar's technological innovation is scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing.
- Position The Quality Assurance Operations Supervisor leads daily QA activities to ensure compliance with GMP regulations and company quality standards.
- This role supports and directs the QA team, manages day-to-day operations, and ensures issues are resolved quickly and effectively.
- The position also oversees key quality processes such as investigations, CAPA, and change management, maintains audit readiness, supports inspections, and drives improvements in processes and efficiency.
- Lead and coordinate day-to-day Quality Assurance operations and team activities.
- Supervise, coach, train, and develop QA staff to ensure compliance and performance expectations are met.
- Assign, prioritize, and monitor work to support departmental objectives and operational needs.
- Maintain audit readiness and support responses to internal and external audit findings.
- Identify and implement improvements to quality processes, systems, and operational efficiency.
Requirements
- One (1) year of direct leadership experience required.
- Working knowledge of applicable regulations, including 21 CFR Parts 210, 211, and 11, and ICH guidelines required.
- Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment.
- shift is required for the first 30 days.
- Personal Protective Equipment (PPE) is required and may include:
Benefits
- As such, schedule flexibility, occasional extended hours, stand-by responsibilities, and holiday work may be required.
- Whether you're drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests.
Company info
- Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
Visa & Work Authorization
- Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.
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