Quality Assurance Specialist (2nd Shift)

NorthStar Medical Radioisotopes • Beloit, WI

1d • Onsite

About The Position

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 The Quality Assurance (QA) Specialist is responsible for providing QA input and guidance for Manufacturing, Supply Chain, Quality, and R&D activities. The QA Specialist will perform all responsibilities in accordance with company policies, procedures, global regulations and safety requirements.

Requirements

• Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and minimum two (2) years GMP related experience in biopharmaceutical/pharmaceutical or related industry with direct Quality experience; or equivalent combination of education and experience.
• Familiarity with pharmaceutical manufacturing processes, 21CFR210/211/820/11.
• 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.

Responsibilities

• Review and approve documents in support of manufacturing and quality testing including batch records, test data, and receiving inspection.
• Review and assess non-conformances; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
• Review, approve and facilitate change controls including tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
• Support remediation efforts to negative quality trends.
• Interact with all departments to effectively implement and maintain Quality Systems.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees