Quality Assurance Specialist (2nd Shift)

About the role

Join a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer. At NorthStar Medical Radioisotopes, you’ll work at the forefront of scientific excellence, using first-in-kind electron accelerator technology and integrated campus capabilities to drive progress in radiopharmaceutical manufacturing. This role supports 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.

Responsibilities

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Quality Assurance
  • 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.
• Quality Systems & Documentation
  • 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 eQMSS.
  • Support development and continuous improvement of quality system processes.
• Investigations & Compliance
  • 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.
• Training, Metrics & Continuous Improvement
  • Train team members on job functions and quality system requirements.
  • Develop and deliver companywide 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.

Requirements

• Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline.
• 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.
• 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.

Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position.