Clinical Lab Scientist

2 months ago

Tucson, United States Compass Consulting Full time

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.


Job Summary:


Responsible for performing high complexity laboratory testing on clinical specimens, interpreting and reporting results and complying with study protocols, Standard Operating Procedures, Test Instructions, and related CAP/CLIA Regulations and guidelines. Participates in scientific studies and activities supporting registrational and non-registrational clinical trials. Receives general instructions; plans and executes own work.


Responsibilities:

  • Works under general supervision, to support aspects of clinical testing and sample processing, adhering to CAP/CLIA regulations and ISO 15189 guidelines.
  • Performs high-complexity testing within the CDx CAP/CLIA Laboratory. Monitors performance of IHC, ISH, molecular assays, and immunoassays; assists with lab failure investigations and root cause analysis.
  • Performs accessioning of biological samples (blood, plasma, tissue) and quality control of demographic data input. Communicates with clients on held and rejected samples.
  • Performs work according to established internal safety guidelines and procedures, and as specified by appropriate regulatory agencies (SHE, OSHA)
  • Critically evaluated quality control and test results against acceptance criteria to support clinical testing.
  • Uses technical writing skills and Good Documentation Practices to complete lab documentation, SOPs, and Quality documents.
  • Participate in routine lab maintenance and lab safety inspections.
  • May perform basic troubleshooting for issues related to instrumentation.
  • Analyzes alternative approaches to solve problems or develop new perspectives on existing solutions; initiate and implement process improvements.


Qualifications:

  • Must possess a BS or BA degree in a related discipline.
  • 1 year experience working in a clinical laboratory.
  • Experience with Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology.


Knowledge, Skills and Abilities:

  • Demonstrated proficiency in computer skills, such as word processing, statistical analysis, and laboratory information systems.
  • Excellent verbal and written communication skills.
  • Strong understanding of good laboratory practices and regulatory compliance.
  • Requires excellent attention to detail; ability to multi-task and be flexible with tasks and schedules.

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