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Quality Control Analyst
Quality Control Analyst-February 2024
Janesville
Feb 8, 2025
About Quality Control Analyst

  JOB REQUIREMENTS: SHINE Technologies is seeking a QC Analyst who willsupport the production of lutetium-177. The QC Analyst will set up andexecute daily testing of final API product and raw materials. TheAnalyst will ensure all QC analytical equipment remains in a state ofvalidation and calibration. Duties and Responsibilities: Specific dutiesand responsibilities of the QC Analyst include, but are not limited to:Perform analysis, evaluate, and report the quality of finished productand ensure compliance with established specifications. Sample rawmaterials per the material specifications and perform in-house testing.Coordinate testing and shipping to contract laboratories for externallab testing. Prepare solutions for testing. Daily set up of QualityControl lab equipment (analytical). Ensure preventative maintenance andcalibration activities for analytical equipment are carried out toschedule. Ensure QC Laboratory is maintained in a clean and compliantmanner. Comply with Good Manufacturing Practices, Good LaboratoryPractices and Good Documentation Practices. Other duties as assigned byManagement. ***** OTHER EXPERIENCE AND QUALIFICATIONS: Minimum: 2-4years of experience in a cGMP/GLP laboratory with experience operatinganalytical instrumentation. Preferred: BS in scientific discipline,analytical chemistry with 0-2 years of experience in Pharmaceuticals,Medical Device or Radiopharmaceuticals, knowledge of HPLC and ICP-MSinstrumentation, and previous work related to radiation pharmaceuticals,ability to conduct analytical assays with knowledge of cGMP, ICH, SP andother global compendial regulations and guidance. Willingness to be\"hands on\" and understand new technology required. Eligibility foremployment is conditioned on the applicant\'s ability to qualify foraccess to information subject to U.S. Export Controls. Additionally,applicant\'s eligibility may be conditioned based upon meeting theNuclear Regulatory Commission requirements for access to SafeguardsInformation, which typically requires a pre-employment drug screen,fingerprinting and criminal background check. SHINE values diversity inall its forms as a critical component of innovation, which isfundamental to our success. Every member of the SHINE community benefitsfrom the talents and experiences of our peers, from the mutual respectwe exercise, and from the responsibility we take for our actions.***** APPLICATION INSTRUCTIONS: Apply Online:https://recruiting.paylocity.com/recruiting/jobs/Apply/2133463/SHINE-Technologies-LLC/QC-Analyst?source=Job%20Center%20of%20WISC

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