Quality Assurance Specialist

NorthStar Medical Radioisotopes; Beloit (WI); Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401(k) match

Paid holidays and PTO

Bonus plan

Equity Incentive Program

Relocation benefit

Résumé du poste

NorthStar Medical Radioisotopes in Beloit, Wisconsin, is seeking a QA Specialist to support manufacturing and quality operations. You will maintain quality systems, ensure GMP/GLP compliance, review production records, and collaborate across teams to uphold quality standards.

The role involves on-floor QA oversight, investigations, audits, and continuous improvement of quality processes, with shifts in a 24-hour facility and relocation benefits available.

Qualifications

• Bachelor’s degree in a scientific discipline with GMP-related experience.
• Experience reviewing production records and documentation for GMP compliance.
• Ability to lead investigations and support CAPA activities.

Responsabilités

• Review and approve production records (electronic and paper) for GMP compliance.
• Review and approve documentation supporting manufacturing and quality system processes.
• Approve CoA activities for final product release and shipment.
• Review environmental monitoring data, media fills, gowning qualifications, and calibration certifications.
• Review controlled documents and assist with eQMS document management.
• Support development and continuous improvement of quality system processes.
• Initiate and investigate nonconformances and deviations; lead root cause analyses.
• Participate in internal and regulatory audits; lead internal audits as assigned.
• Train team members on job functions and quality system requirements.
• Create and report departmental quality metrics; support new process implementations.

Connaissances

GMP experience

QA oversight

Documentation

Audit support

Formation

Bachelor’s Degree in Chemistry/Biology or related field

Description du poste

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.

Position

The Quality Assurance (QA) Specialist supports manufacturing and quality operations by maintaining quality systems and ensuring compliance with GMP, GLP, safety, and regulatory requirements. This role provides on the floor QA oversight, supports quality issue remediation, and collaborates with cross-functional teams to uphold quality standards.

All responsibilities are performed in accordance with company policies, procedures, global regulations, and safety requirements.

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
• 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

Early Development

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.

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.

Shift Information

This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required. Early morning, weekend, and some holiday work will be required.

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

Working Conditions

This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include:

• Exposure to varying temperatures, both indoors (heated/air-conditioned spaces) and outdoors
• Noise levels range from quiet to loud, depending on the work area
• Specific vision abilities, including near vision, visual acuity, and color discrimination

Personal Protective Equipment (PPE) is required and may include:

• Respirators, gloves, safety glasses, and full protective clothing
• Compliance with cleanroom gowning protocols (e.g., removal of all jewelry, including piercings)
• Prohibition of cosmetics, fragrances (perfume, aftershave), and nail products, including polish, artificial nails, or extensions

As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to:

• Follow strict radiation safety procedures
• Participate in dosimetry monitoring and bioassay testing as part of the company protocol
• Inform leadership of any health conditions that may affect product integrity, by cleanroom standards

Location

NorthStar Medical Radioisotopes is proud to call Beloit, Wisconsin home. Our headquarters and primary manufacturing facility are located in this vibrant, growing community that combines the charm of a small city with the advantages of a central Midwest location. Beloit features a lively, revitalized downtown filled with local restaurants, shops, and cultural events, and is just a short drive from major metropolitan areas including Madison, Milwaukee, Chicago, and Rockford.

Situated in the heart of the South Central Wisconsin and Northern Illinois region, Beloit offers a rare blend of urban amenities and scenic natural surroundings. Whether you’re drawn to outdoor recreation, educational institutions, the arts, or historic landmarks, the area provides rich and diverse experiences for all interests. A variety of nearby communities, ranging from rural towns to suburban neighborhoods, offer flexible housing options and access to multiple school districts, making Beloit an excellent choice for individuals and families considering relocation.

Please note that this position is eligible for a lump sum relocation benefit!

NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.