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Clinical Laboratory Specialist

Amerit Consulting
Franklin, NJ Temporary
POSTED ON 1/20/2025
AVAILABLE BEFORE 4/20/2025

Position : Clinical Lab Scientist

Location : Franklin Lakes, NJ 07417

Duration : 12-month contract with possible extension

Pay Rate : $40 / hr - $44 / hr (depending on experience)

Relocation Expenses / Assistance : NO

Job Description :

  • Work on-site in Franklin Lakes 5 days a week from 8 : 30 AM to 5 : 00 PM.
  • Handle human blood within a dynamic laboratory environment.
  • Contribute to the design, evaluation, execution, and reporting of safety and efficacy for innovative in-vitro diagnostic devices.
  • Utilize your expertise in clinical laboratory disciplines including phlebotomy, chemistry, hematology, coagulation, urinalysis, and point of care testing, while operating various instrument platforms.
  • Oversee clinical laboratory studies and perform complaint testing using diverse clinical testing methods.
  • Showcase your knowledge in demonstrating the safety and effectiveness of new or modified in-vitro diagnostic devices.
  • Collaborate with R&D to develop and implement new testing methodologies.
  • Understand product design and function while applying quality and regulatory standards effectively.
  • Perform Clinical Software Validations (CSV) for new instrument validation / qualification, ensuring best practices in IQ / OQ / PQ compliance.
  • Engage with multiple disciplines (manufacturing, marketing, quality, regulatory, etc.) to support clinical laboratory operations and services.
  • Conduct scientific investigations, contributing innovative ideas and solutions to complex projects.
  • Adapt methodologies as necessary to maintain alignment with core laboratory goals.
  • Conduct clinical testing and maintain laboratory instruments, reagents, and inventory in line with lab priorities and business objectives.
  • Implement and document effective Quality Assurance and Quality Control procedures.
  • Carry out instrument verification according to CLSI guidelines, and assist with updates and compliance documentation related to GLP and GCP.
  • Stay informed in the field of Clinical Laboratory Science through continued education and literature reviews.
  • Train new associates on laboratory workflows and procedures.
  • Monitor trends in laboratory practices and recommend new initiatives to enhance operations.
  • Contribute to the clinical strategy for IDS-Specimen Management products and support the generation of scientific and clinical data.
  • Ensure scientific integrity and clinical accuracy of communications regarding PAS products globally.
  • Manage individual and complex projects involving multiple internal clinical studies and evaluations.
  • Utilize clinical expertise to resolve customer complaints through investigations.
  • Support innovation, product development, clinical testing, and post-market surveillance by collaborating with R&D and GCD.

Job Requirements :

  • BS / BA / MA in Clinical Laboratory Science, Medical Technology, Biology, or a related health field.
  • MT / MLT CLS (ASCP) certification or equivalent research experience.
  • 5 years of experience in a Clinical Laboratory setting.
  • Solid working knowledge of clinical laboratory science.
  • Strong verbal and written communication skills.
  • Basic awareness of GCP / GLP and ISO regulations.
  • Experience with Clinical Software Validations (CSV) and instrument validation best practices.
  • Phlebotomy skills are a plus.
  • Experience with human blood specimen collection products.
  • Proficiency in troubleshooting clinical results.
  • Advanced computer skills and project management capabilities.
  • Proven ability to develop and implement new testing methodologies in cooperation with R&D.
  • Comprehensive understanding of laboratory testing, blood collection, urinalysis, and LIS / LIMS systems, with an ability to apply this knowledge creatively in projects beyond core clinical practices.
  • Salary : $40 - $44

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