Laboratory Technologist

1 month ago

Parsippany, New Jersey, United States Kaztronix Full time
Job Summary

As a Laboratory Technologist at Kaztronix, you will play a crucial role in supporting product development in the US for new Hematology and Hemostasis products. You will work closely with R&D, Clinical, and Regulatory teams in the US and France to provide clinical performance information and ensure compliance with U.S. regulatory requirements.

Key Responsibilities
  • Stay up-to-date with instrument capabilities and clinical trial regulations to provide input to clinical trial designs and execution.
  • Interact with organizations such as CLSI, CLIA, and CAP to ensure Kaztronix is at the forefront of market evolution.
  • Collaborate with French counterparts to conduct and support R&D activities and clinical trials in the US for new product launches.
  • Participate in study protocol development and ensure study designs are suitable for execution in the lab.
  • Verify technical conditions before study commencement, ensuring instruments are in working order and maintenance is up-to-date.
  • Coordinate logistical aspects of clinical studies, including reagent and instrument delivery, specimen exchange, and administrative tasks.
  • Ensure full understanding of protocol requirements to facilitate efficient study execution and meet organizational timelines.
  • Work with the NCRA to conduct site initiation and monitoring visits, and ensure corrective actions are taken for proper conduct.
  • Verify completeness of records, centralize and format data, and ensure traceability.
  • Apply knowledge of instrument validation, interference, and stability to perform Linearity and Method Comparison testing.
  • Maintain laboratory equipment according to daily, weekly, and monthly schedules, and perform quality control for analyzers.
  • Participate in validation of new equipment as necessary.
  • Assist in the development and maintenance of clinical study binders and eCRF utilization.
  • Manage laboratory equipment service contracts and clinical trial documentation.
  • Provide scientific presentations as required.
  • Support new product launches as needed.

Requirements
  • Bachelor's degree in Medical Technology/Clinical Laboratory Science or equivalent from an accredited institution.
  • Minimum five years of experience in Hematology and Coagulation, preferably with instrument validations, correlations, and training.
  • Proficiency in Excel and Windows Office Suite Applications.
  • Ability to read, analyze, and interpret complex documents, respond to technical inquiries, and deliver effective presentations.
  • Travel may be required up to 10%, including international travel.

  • Laboratory Technologist

    1 month ago

    Parsippany, United States Kaztronix Full time

    Description Execute Clinical Testing to support product development in the US for new Hematology and Hemostasis products (reagents and analyzers), working with R&D, Clinical and Regulatory in the US and France to provide appropriate clinical performance information to support device development as well as meeting U.S. regulatory requirements. Provides...