Overview

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 supervisor is responsible for training, coaching, and evaluating staff while promoting a culture of quality and continuous improvement. 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. Projects and duties will be completed in compliance with applicable regulatory agency standards.

Responsibilities

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• 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.
• Conduct regular team meetings, provide feedback, and complete performance evaluations for direct reports.
• Ensure team compliance with GMP requirements, quality systems, procedures, and applicable regulations.
• Oversee timely completion of investigations, CAPAs, change controls, and other quality system activities.
• Maintain audit readiness and support responses to internal and external audit findings.
• Promote a culture of quality, compliance, accountability, and continuous improvement.
• Identify and implement improvements to quality processes, systems, and operational efficiency.
• Monitor quality metrics and support risk management and continuous improvement initiatives.
• Coordinate with QA Operations to ensure that development programs and projects can be implemented efficiently and cost effectively within the operational environment.

Early Development

After 3 months you will:

• Understand Quality Assurance Operations roles and responsibilities as they apply to radiopharmaceutical manufacturing.
• Complete Radiation Training for Building access.
• Review, approve and ensure timely closure of quality documentation
• Provide QA oversight and operational support during manufacturing activities

After 6 months you will:

• Independently review, approve and provide oversight for Document Change Orders (DCO) and Change Requests (CR) impacting operations and quality system documentation
• Oversee final Batch release, and completion/approval of CoA (Certificate of Analysis)
• Lead and review investigations of quality events
• Demonstrate independent decision-making and leadership during production activities ensuring compliance, product quality, and efficient issue resolution

Qualifications

MINIMUM EDUCATION/EXPERIENCE:

Bachelors degree in chemistry, Biology, or other related scientific discipline with a minimum of six (6) years of GMP-related experience in biopharmaceutical, pharmaceutical, or related industry with direct quality experience; or equivalent combination of education and experience. 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.

PREFERRED EDUCATION/EXPERIENCE:

• Prior experience supervising Quality Assurance personnel in a regulated GMP manufacturing environment.
• Experience leading investigations, CAPAs, change controls, and audit activities.
• Demonstrated experience driving continuous improvement, risk management, or lean manufacturing initiatives.
• Strong knowledge of pharmaceutical or biopharmaceutical manufacturing processes and quality systems.
• American Society of Quality (ASQ) certification preferred.

Shift Information

Second shift hours are Monday 6Friday, generally 3:00 p.m. to 12:00 a.m. (shift concludes Friday night). Actual daily hours may vary slightly depending on meal breaks. During the training period (approximately 60 days), the ability to work 1st shift is required for the first 30 days. Primary shift placement will be assigned upon successful completion of the training program. This position supports production in a 24-hour, Monday 6Friday manufacturing environment. As such, schedule flexibility, occasional extended hours, stand-by responsibilities, and holiday work may be required.

Benefits

• Medical, dental, and vision insurance
• Healthcare Flex Spending Account (FSA) and Dependent Care FSA
• Company-paid short-term and long-term disability
• Company-paid life insurance & AD&D coverage
• Pet insurance
• 401(k) match
• Paid holidays and paid time off (PTO)
• Paid parental leave
• Bonus plan
• Equity Incentive Program

Working Conditions

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:

• Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
• Noise levels range from quiet to loud, depending on the work area
• Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

• Respirators, gloves, safety glasses, and full protective clothing
• Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
• Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:

• Follow strict radiation safety procedures
• Participate in dosimetry monitoring and bioassay testing as part of the company protocol
• Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

Location

NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. 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.

Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether youre drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation.