Clinical Laboratory Specialist

1 day ago


Franklin Lakes, New Jersey, United States Insight Global Full time
Job Title: Clinical Laboratory Specialist

Insight Global is seeking a highly skilled Clinical Laboratory Specialist to join our team in Franklin Lakes, NJ. This role will involve designing, evaluating, executing, and reporting on the safety and efficacy of in-vitro diagnostic devices.

Key Responsibilities:
  • Conduct clinical testing and manage laboratory studies and complaint testing.
  • Develop and implement new testing methodologies in collaboration with R&D.
  • Perform Clinical Software Validations (CSV) and instrument validation/qualification.
  • Maintain laboratory instrumentation and reagent test systems.
  • Implement and document Quality Assurance and Quality Control procedures.
  • Train new associates and stay current in Clinical Laboratory Science through continuing education.
  • Resolve customer complaints through clinical investigations.
  • Support innovation, product development, clinical testing, manufacturing, and post-market surveillance.
Requirements:
  • 1-5+ years of experience in a Clinical Laboratory environment.
  • Strong knowledge of clinical laboratory science.
  • Excellent verbal and written communication skills.
  • Experience testing medical instruments (syringes, catheters, etc).
  • Experience processing specimens within the hematology, clinical chemistry, and urinalysis spaces.
  • Awareness of GCP/GLP and ISO regulations.
  • Experience with human blood specimen collection products.
  • Strong computer skills and project planning/budget management skills.
  • BS/BA/MA in Clinical Laboratory Science, Medical Technology, Biology Life Sciences, or a related health field.

Insight Global is an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.



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