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Full-time
bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Healthcare Flex Spending Account (FSA), Dependent Care FSA, Short-term Disability
Posted 18d ago
Apply by Jul 21
~40 hrs/week
Responsibilities
The QA Specialist maintains quality systems and ensures compliance with GMP, GLP, and regulatory requirements through on-the-floor oversight. Key duties include reviewing production records, managing nonconformances, and leading root cause analyses to support continuous improvement.
Requirements
Requires a Bachelor's degree in Chemistry, Biology, or a related scientific field with at least three years of GMP experience in a regulated industry. Candidates must be able to work second shift and comply with strict cleanroom and radiation safety protocols.
Full 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.
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
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.
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.
One Mission. One Campus. Providing Patients Global Access to Game-Changing Radiopharmaceuticals.
Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Founded
2006
LinkedIn followers
15,672
Total funding
$117M
NorthStar is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies.
NorthStar produces copper-67 (Cu-67) and is the first commercial-scale producer of no-carrier-added actinium-225 (n.c.a. Ac-225) using electron-accelerator technology. The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs.
For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com.
Health DiagnosticsHealth CareHospitalityManufacturingPharmaceuticalTherapeutics
Based on 1240 listings with disclosed salaries, most manufacturing jobs in Wisconsin pay between $64k–$142k per year. Individual offers vary with seniority, company size, and specialization.
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There are currently 9,905 open manufacturing positions in Wisconsin listed on Clera. New openings are added daily as companies post roles.
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