Quality Assurance Specialist (2nd Shift)

NorthStar Medical Technologies; Beloit (WI); On-site; USD 70,000 - 110,000; Full time

Job summary

NorthStar Medical Radioisotopes in Beloit, WI, seeks a Quality Assurance professional to ensure GMP-compliant manufacturing and documentation in a fast-growing radiopharmaceutical environment. You will help maintain product quality and regulatory readiness across complex processes.

The role focuses on reviewing records, approving CoA for final releases, supporting CAPAs, and driving continuous improvement within the eQMS to sustain patient safety and supply reliability.

Qualifications

• Bachelor’s Degree in Chemistry, Biology, or related field with GMP experience.
• Minimum three years of GMP-related experience in biopharma or regulated industry.
• Immigration sponsorship not provided; Form I-9 completion required.

Responsibilities

• Review and approve production records to ensure GMP compliance.
• Review and approve documentation supporting manufacturing and quality processes.
• Approve Certificate of Analysis (CoA) activities for final product release and shipment.
• Review environmental monitoring data and calibration certifications.
• Develop and improve quality system processes.
• Train team members on quality system requirements.

Skills

GMP knowledge

Quality Assurance

Documentation

Audit experience

Education

Bachelor’s Degree in Chemistry, Biology

Tools

eQMS experience

Job description

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.

Responsibilities

• Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
• Quality Assurance Responsibilities
  • 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 eQMS
  • 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
• 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

Qualifications

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.