Quality Assurance Specialist (2nd Shift)
On-siteBeloit, Wisconsin, United States
Job Summary
Review and approve production records, batch records, test data, and environmental monitoring data to ensure GMP compliance. Initiate investigations into nonconformances, deviations, and out-of-specification results while performing root cause analyses. Collaborate with cross-functional teams on document change orders and lead internal audits. Train team members on quality system requirements and eQMS processes. Work Monday through Friday on the second shift (3:00 p.m. to 12:00 a.m.) in a radiopharmaceutical manufacturing environment. This role supports NorthStar Medical Radioisotopes in advancing patient care through therapeutic radioisotopes and novel radiopharmaceuticals.
Required Qualifications
- 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
- equivalent combination of education and experience
- ability to work 1st shift for the first 30 days during the training period
- schedule flexibility
- occasional extended hours
- stand-by responsibilities
- holiday work
- Specific vision abilities, including near vision, visual acuity, and color discrimination
- 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
- 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
- Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization
Desired Qualifications
- Complete Radiation Training for Building access
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