Quality Assurance Specialist; 2nd Shift

Quality Assurance Specialist

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, North Star Medical Radioisotopes is the place to do it. North Star 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 North Star'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.

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Review and approve production records (electronic and paper) to ensure accuracy, completeness, and compliance with GMP requirements
• Review and approve documentation supporting manufacturing and quality system processes, including batch records, test data, and supporting records
• Approve Certificate of Analysis (CoA) activities for final product release and shipment
• Review and approve environmental monitoring (EM) data, media fills, gowning qualifications, and calibration certifications
• Review, collaborate on, and approve controlled documents, including document change orders (DCOs) and change requests for released processes
• Author, revise, distribute, and reconcile controlled documents within the eQMS
• Support development and continuous improvement of quality system processes
• Initiate, investigate, and approve nonconformances, deviations, and laboratory out-of-specification (OOS) results
• Perform risk assessments and lead root cause analyses to support corrective and preventive actions
• Participate in internal, sponsor, and regulatory audits; lead internal audits as assigned
• Train team members on job functions and quality system requirements
• Develop and deliver company wide training on eQMS processes
• Create, track, and report departmental quality metrics
• Serve as a subject matter expert (SME) to support continuous improvement initiatives and new process implementation

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 and approve documentation for closure independently.
• Perform QA support functions during operations with QA trainer.

After 6 months, you will:

• Collaborate and approve Document Change Orders as applicable to operations and quality system documentation.
• Perform final BPR review and CoA completion for release and shipment.
• Review and investigate Events, review change requests for completeness.
• Collaborate with cross-functional departments, provide guidance and continuous improvements.
• Work independently with the ability to make decisions during production activities.

Bachelor's Degree in Chemistry, Biology, or other related scientific discipline and minimum three (3) years GMP related experience in biopharmaceutical/pharmaceutical or other regulated industry with direct Quality experience; or equivalent combination of education and experience.

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.

Second shift hours are Monday–Friday, 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–Friday manufacturing environment.

As such, schedule flexibility, occasional extended hours, stand-by responsibilities, and holiday work may be required.

• 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…