Supervisor, Quality Control

Overview:

Join the best radiopharmaceutical company in the world

If you're looking to make an impact while building a meaningful career in a specialized, fast-growing field, NorthStar Medical Radioisotopes is the place to do it. 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.

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. Our work is driven by a meaningful mission—advancing life-saving radiopharmaceutical development and ensuring a reliable supply of critical medical isotopes for patients in need. As a rapidly growing organization operating on the cutting edge of science, we offer exceptional career growth and professional development opportunities, supported by world-class facilities and a competitive benefits package.

Position:

This position is responsible for planning, managing, and supervising the activities of a Quality Control (QC) team. This role provides oversight of staffing, lab policies, and quality procedures. The QC Supervisor will provide quality control oversight and direction from incoming material inspection through product release to ensure quality processes are cGMP compliant and maintained. Projects and duties will be completed in compliance with applicable regulatory agency standards.

Responsibilities:

• Serve as the subject matter expert in certain areas of Quality Control.
• Provide on-the-floor QC oversight of manufacturing operations.
• Provide support and training to Quality Control Specialists in respect to component inspection, product testing, and laboratory analyses.
• Recruit, manage, and develop a team of quality specialists to ensure compliance with the applicable regulations and support NorthStar's Core Values.
• Develop and implement new programs/processes designed to drive continuous improvement.
• Exhibit strong problem solving skills, taking initiative, and focus on achieving company goals.

Early Development:

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories
• Trained on ALARA principles and RAD safety
• Provide support for routine manufacturing operations
• Start training on final product testing and batch release processes

After 6 months you will:

• Be qualified on analytical techniques and instrumentation
• Be proficient in the majority of QC batch release activities
• Support stability and product validation testing
• Be qualified to provide training to other team members on certain QC functions

Qualifications:

Bachelor's Degree in a scientific discipline and a minimum of four (4) years of experience in Quality in the pharmaceutical, radiopharmaceutical, and/or medical device industry with a minimum of one (1) year of experience leading others; or equivalent combination of education and experience. Knowledge of International Society for Pharmaceutical Engineering (ISPE) standards. American Society of Quality (ASQ) certification preferred.

Additional required experience includes:

• Managing audits by regulatory agencies and customers.
• Interacting directly with regulatory agencies and customers.
• Execution of Quality Control testing and methods.
• Knowledge of regulations/standards/guidance (specifically 21 CFR 210 & 211, ICH Q7, Q8, Q9, and Q10).

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. 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. Under federal law, only truthful information may be provided on the Form I-9.

Shift Information:

Second shift hours are Monday, Tuesday, Wednesday, Thursday 1:30pm –midnight (off on Fridays). During this position's training period (approximately 60 days), the ability to work an alternate shift at least once during the training period is required. Primary shift placement will occur upon completion of the training program. Additionally, this position supports production in a 24-hour manufacturing facility, Monday to Friday, occasional overtime and holidays required.

Benefits:

• Medical, dental, and vision insurance
• Healthcare Flex Spending