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Advanced Assay Office/Validation Analyst

Bio-Techne · Minneapolis, MN

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QualityFull-time$56k–$91kCompany career page

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Role summary

Bio-Techne seeks an Advanced Assay Office/Validation Analyst to manage assay value assignment, perform calculations, and support product validation activities in a quality assurance capacity. The role involves data analysis, documentation preparation, and collaboration with validation and regulatory teams.

What they're looking for

  • Bachelor's degree in Medical Technology, Biological Sciences, or equivalent education and clinical laboratory experience
  • 3–5 years of related experience in laboratory or quality assurance settings
  • Hematology experience preferred
  • Proficiency with Microsoft Word, Excel, and computer entry/typing skills
  • Strong problem-solving, data analysis, and professional communication abilities
  • Knowledge of laboratory equipment and ability to work independently and with teams
  • Familiarity with CLSI EP05 and ISO 13485 standards desired

What you'll be doing

  • Perform assay value assignments and prepare calculations for assay sheet templates and data entry
  • Maintain product history records, monitor assay quality, and review finishing and laboratory documentation
  • Write, review, and maintain assay office procedures; collaborate on validation summaries and reports
  • Prepare and proofread Certificates of Analysis and batch records for internal and OEM customers
  • Coordinate customer data with QC laboratory testing and assist with calibration decisions for analyzers

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Date posted4 days ago
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