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NorthStar Medical Radioisotopes

Produces diagnostic and therapeutic radiopharmaceuticals.

Quality Control Analyst

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBeloit, WI, USA

About the Job

Requirements

  • A high school diploma or general education degree (GED) and at least four years of experience in a regulated industry, such as analytical instrumentation or prior laboratory experience; alternatively, a bachelor's degree in chemistry, biology, or another related scientific discipline, or an equivalent combination of education and experience.
  • Familiarity with basic to advanced metrological equipment is preferred.
  • Knowledge of ALARA principles, radiation detection equipment operation, and radioactive-material handling is preferred.
  • Experience with benchtop chemistry, titration, and chemical identification testing is preferred.
  • The role requires working an alternate shift at least once during the approximately 60-day training period.
  • Occasional overtime and holiday work is required.
  • The role requires use of personal protective equipment, compliance with cleanroom gowning protocols, and adherence to radiation-safety procedures; dosimetry monitoring and bioassay testing may be required.
  • The position requires near vision, visual acuity, and color discrimination.

Responsibilities

  • Monitor equipment and instrumentation daily to ensure proper operation and calibration.
  • Operate analytical instrumentation.
  • Provide an on-the-floor quality control presence for manufacturing operations.
  • Perform incoming inspection of raw materials and components.
  • Review and approve receiving inspection documents and release them in the enterprise resource planning (ERP) system.
  • Perform environmental monitoring tasks and plate reads.
  • Isolate microorganisms.
  • Collaborate on document change orders (DCOs) supporting manufacturing and quality testing, including test data, protocols, reports, and standard operating procedures (SOPs).
  • Safely handle radioactive material, including monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys.
  • Maintain the quality control and microbiology laboratories through routine housekeeping, logbook review, and inventory maintenance.
  • Train others on methods, procedures, and techniques as required.
  • Participate in project teams and other meetings.
  • Support production in a 24-hour manufacturing facility, Monday through Friday.

About the Company

NorthStar Medical Radioisotopes

Produces diagnostic and therapeutic radiopharmaceuticals.

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Company size
201-500
Company stage
Debt Financing
Total funding
$302.5M
Headquarters
Madison, WI
Founded
2006

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