Supervisor, Quality Control (2nd shift)

NorthStar Medical Radioisotopes • Beloit, WI

13d • Onsite

About The 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.

Requirements

• Bachelor’s Degree in a scientific discipline and a minimum of four (6) 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.
• 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).
• 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.

Nice To Haves

• American Society of Quality (ASQ) certification preferred.

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.

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
• Relocation benefit

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level