Quality Control Specialist (1st shift)

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

Job summary

NorthStar Medical Radioisotopes is seeking a skilled analytical scientist in Beloit, Wisconsin, to operate analytical instrumentation and support regulatory testing in a fast-growing radiopharmaceutical setting.

The role includes documenting in the eQMS, training teammates on methods, and performing environmental monitoring and CAPA investigations as part of a cross-functional team.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related science with 3+ years in a regulated industry.
• Experience with analytical instrumentation and laboratory testing in a regulated setting.
• Familiarity with alpha, gamma, and beta spectroscopy is a plus.

Responsibilities

• Operate analytical instrumentation.
• Author and revise documents in the eQMS system.
• Train others on methods, procedures and techniques as required.
• Safely handle radioactive material, including monitoring dose and sampling.
• Perform and review receiving inspection tasks for ERP release.
• Perform environmental monitoring per applicable standards.
• Participate in DCO collaboration of documents for manufacturing and testing.
• Perform technical review of analytical data and lab logbooks.
• Execute microbiological, chemical, radiochemical, and stability testing.
• Initiate and approve non-conforming material reports (NCMRs) and CAPA investigations.
• Participate in multiple Project Teams and meetings.

Skills

Analytical instrumentation

GMP compliance

Laboratory data review

Documentation & eQMS

Education

Bachelor's degree in Chemistry, Biology, or related scientific discipline

Tools

eQMS system

ERP system

Job description

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.

• Operate analytical instrumentation.
• Author and revise documents in the eQMS system.
• Train others on methods, procedures and techniques as required.
• Safely handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys.
• Perform and review receiving inspection tasks for release in the ERP system.
• Perform environmental monitoring in accordance with all applicable standards.
• Participate in DCO collaboration of documents in support of manufacturing and quality testing including test data, protocols, reports, SOPs.
• Perform technical review of analytical data and lab logbooks
• Execute microbiological, chemical, radiochemical, and stability testing.
• Initiate and approve non-conforming material reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations.
• Participate in multiple Project Teams and other meetings.

Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and minimum three (3) years of experience in a regulated industry (e.g., analytical instrumentation / prior laboratory experience) ; or equivalent combination of education and experience. Preferred qualifications include:

• Four (4) years of related experience in a cGMP environment and previous experience handling radioactive materials.
• Understanding of pharmaceutical manufacturing processes, and familiarity with batch production records (BPR) preferred.
• Familiarity with alpha, gamma, and beta spectroscopy is a plus.

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.