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    Clinical Lab Scientist I - Tucson, United States - Planet Pharma

    Planet Pharma
    Planet Pharma Tucson, United States

    2 weeks ago

    Default job background
    Description

    CONTRACT

    MUST HAVES:

    • Bachelor's Degree Must possess a BS or BA degree in a related discipline
    • 1 year experience working in a clinical laboratory, histology laboratory (CAP/CLIA), or similar laboratory setting
    • Experience and/or knowledge of Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), immunoassays and molecular biology techniques

    Description:

    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.


    • Other duties as assigned by management.

    Education Level:


    • Bachelor's Degree Must possess a BS or BA degree in a related discipline (REQUIRED)

    Years of Experience:


    • 1 year experience working in a clinical laboratory (PREFERRED)


    • Immunohistochemistry (IHC), chromogenic in-situ hybridization (ISH), histology lab experience (CAP/CLIA), immunoassays and molecular biology experience. (PREFERRED)

    Knowledge, Skill or Ability:


    • Demonstrated proficiency in computer skills, such as word processing, statistical analysis, and laboratory information systems. (REQUIRED)


    • Excellent verbal and written communication skills. (REQUIRED)


    • Strong understanding of good laboratory practices and regulatory compliance. (REQUIRED


    • Requires excellent attention to detail; ability to multi-task and be flexible with tasks and schedules. (REQUIRED)

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