Kirsten Hurst

Experience

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  ImpactLife

  Jan 2005 - Jan 2010

  Nucleic Acid Testing Lab, Bench Technician

  Performed PCR testing for HIV, HCV, and HBV and rtPCR testing for WNV, as company trained SME.• Performed duties within Phase III Clinical Trials of new testing platforms.• Validated testing and computer systems, analyzed and audited results prior to batch release.

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  ImpactLife

  Aug 2010 - Nov 2015

  • Supervised daily lab operations for shift staff—communicating changes and priorities to team.• Performed non-conformance audits and root cause analysis.• Managed quality control procedures and data capture.• Performed regulatory and QC document reviews.• Operated, maintained and serviced equipment in the scope of IVD testing: ELISA, flow cytometry, immunoassay and solid phase platforms.• SME for immunoassay platform testing and training.• IQ, OQ, PQ validation team experience with working knowledge of FDA expectations.• Authored, reviewed, revised, and validated SOPs, forms and job aids ensuring clarity, completeness, and accuracy.• Supported validations for LIS implementation and testing platform qualifications in compliance with CFRs.• Prepared site/interacted with auditors for FDA, AABB, European pharmaceutical inspections. Show less

  • Immunohematology Reference Lab Tech

    Sept 2011 - Nov 2015

  • Lead Tech, Processing Laboratory

    Aug 2010 - Nov 2015
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  American Red Cross

  Nov 2015 - Dec 2022

  Immunohematology Reference Technologist

  • Perform complex patient antibody identifications as a part of blood bank requisitions with strong written/verbal communication development.• Consulted clients on recommendations.• Supported strong relationships with over 50 hospital clients to maximize efficient turn-around-time metrics.• Performed GMP regulatory documentation and methodologies.• EDM/QMS experience.• Managed sample submissions for molecular genotyping and National Inventory Management System. • Provided immunohematology related educational presentations for large groups at local conferences.• Acted as a voice of the customer—communicating new ideas and needs upward to leadership. • Strategic analytical skills with an ability to adapt to a changing, fast-paced environment. Show less

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  QuidelOrtho

  May 2023 - now

  Field Application Specialist