Clinical Lab Specialist

1 week ago

Franklin Lakes, NJ, United States Cynet Systems Full time
Job Description:

Pay Range: $50.57hr - $53.57hr
  • The Clinical Lab Specialist supports scientific investigations, conducts clinical testing, maintains laboratory instrumentation, and ensures compliance with quality and regulatory standards.
  • This role contributes to clinical strategy, supports product development, and provides clinical expertise across multiple projects.
Requirement/Must Have:
  • bility to conduct scientific investigations and recommend solutions.
  • Experience adapting methodologies for clinical laboratory needs.
  • bility to conduct clinical testing and maintain instrumentation and reagent systems.
  • Experience implementing and documenting QA/QC procedures.
  • bility to perform instrument verification per guidelines and assist with procedure updates.
  • Experience performing Clinical Software Validations and instrument validation/qualification.
  • bility to stay current with clinical laboratory science developments.
  • bility to train new associates on laboratory workflow.
  • bility to identify laboratory practice trends and recommend projects.
  • Experience supporting clinical strategy and generating scientific information for products.
  • bility to resolve customer complaints through clinical investigations.
  • bility to support innovation, product development, clinical testing, manufacturing, and post-market activities.
Experience:
  • 5+ years of experience in a clinical laboratory environment.
  • Experience in clinical laboratory testing, blood collection, urinalysis, and LIS/LIMS systems.
  • Experience conducting or supporting clinical investigations.
  • Experience supporting multiple clinical projects.
Responsibilities:
  • Conduct scientific investigations and recommend concepts and principles.
  • dapt methodologies for core clinical laboratory operations.
  • Conduct clinical testing and maintain instrumentation and inventory.
  • Implement and document QA/QC procedures.
  • Perform instrument verification and assist with procedure and documentation updates.
  • Conduct Clinical Software Validations and support instrument qualification activities.
  • Participate in continued education and stay updated on laboratory science
  • Train new laboratory associates.
  • Monitor laboratory trends and recommend new initiatives.
  • Support clinical strategy and contribute scientific information to product development.
  • Ensure scientific and clinical accuracy of product claims.
  • Manage individual and complex clinical projects.
  • Resolve customer complaints through clinical investigation.
  • Support innovation, clinical testing, product development, and post-market surveillance.
Should Have:
  • Familiarity with GCP/GLP and ISO regulations.
  • Understanding of product troubleshooting related to clinical results.
  • bility to collaborate with R&D on new testing methodologies.
  • Experience with human blood specimen collection products.
Skills:
  • Strong working knowledge of clinical laboratory science.
  • Strong communication skills.
  • Strong computer skills.
  • Project planning and budget management skills.
Qualification And Education:
  • BS/BA/MA in Clinical Laboratory Science, Medical Technology, Biology, Life Sciences, or a related field.
  • MT/MLT CLS (ASCP) or equivalent experience in a research environment.

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