Quality Control Analyst (2nd shift) at NorthStar Medical Technologies in US-WI-Beloit

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.
• The primary role of this position is to provide operational support for the Quality Control (QC) cGMP functions for laboratory, radiologic science laboratory, and manufacturing operations. Role will focus on support activities, such as sampling, material inspection, and general laboratory testing/support.
• Projects and duties will be completed in compliance with applicable regulatory agency standards.

Responsibilities

• Monitor equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
• Operate analytical instrumentation.
• Provide on-the-floor QC presence for manufacturing operations.
• Perform incoming inspection of raw materials and components.
• Review and approve Receiving Inspection documents and release in the ERP system.
• Perform environmental monitoring tasks and plate reads
• Isolate microorganisms
• Participate in DCO collaboration of documents in support of manufacturing and quality testing including test data, protocols, reports, SOPs.
• Safely handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys.
• Maintain QC and Micro lab which includes routine housekeeping, review of logbooks and inventory maintenance.
• Train others on methods, procedures and techniques as required.
• Participate in Project Teams and other meetings.

Requirements

• High school diploma or general education degree (GED) and minimum four (4) years of experience in a regulated industry (e.g., analytical instrumentation / prior laboratory experience) ; OR Bachelor's Degree in chemistry, biology, or other related scientific discipline; OR equivalent combination of education and experience. Preferred qualifications include:
• Familiarity with use of basic to advanced metrological equipment.
• Knowledge of ALARA principles, operating radiation detection equipment, and handling of radioactive materials.
• Benchtop chemistry, titration, chemical ID testing.
• 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.

Skills

Required

• Analytical instrumentation operation
• Laboratory testing
• Sampling
• Material inspection
• Environmental monitoring
• Microorganism isolation
• Documentation and SOPs
• Radioactive material handling
• Equipment monitoring and calibration
• ERP system usage
• Training others

Preferred

• Knowledge of ALARA principles
• Operating radiation detection equipment
• Handling of radioactive materials
• Benchtop chemistry
• Titration
• Chemical ID testing