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    Laboratory Technician II - Louisville, United States - Biodesix, Inc.

    Biodesix, Inc.
    Biodesix, Inc. Louisville, United States

    3 weeks ago

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    Description

    ABOUT US:
    Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases.

    The blood based Nodify Lung nodule risk assessment testing strategy, consisting of the Nodify XL2 and the Nodify CDT tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action.

    The blood based IQLung strategy for lung cancer patients integrates the GeneStrat targeted ddPCR test, the GeneStrat NGS test and the VeriStrat test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment.

    Biodesix also leverages the proprietary and advanced Diagnostic Cortex AI (Artificial Intelligence) platform, to collaborate with many of the world's leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease.

    For more information about Biodesix, please visit


    OBJECTIVE OF THE POSITION:
    Laboratory Technicians II assist with the setup and support of the daily activities of the laboratory.

    In addition, Laboratory Technicians II have the technical training and experience required to perform regulated clinical laboratory test realization (test specimen receipt through test result generation) using standard in-vitro laboratory techniques in Molecular Biology (PCR) and in Mass Spectrometry.

    Our focus areas of test development include oncology and virology.

    This experienced candidate is comfortable with SOPs and Work Instructions, working with data, standard laboratory chemicals, human blood specimens and is versed in standard molecular biology techniques (PCR, nucleic acid isolation/purification and sequencing).

    The position also works in a functional matrix organization, including Development, Customer Service, Accounting, Quality Operations management team, the Laboratory Directors, and other departments as needed.

    Ongoing training will be provided to supplement key skills required to perform the functions of this position as applicable.

    Required:

    Must embrace a culture of transparency, willing and open to share data and technical knowledge, excellent communication skills, on time delivery of complete and quality results.

    Surfaces issues promptly to manager with follow through to a resolution.


    Appropriate designees may act as responsible delegates according to the Biodesix Quality Matrix, including day to day responsibilities required for CAP/CLIA as well as all state-specific requirements in which Biodesix is an approved test facility.


    REGULATORY REQUIREMENTS:
    This role shall comply, at a minimum, with the responsibilities and qualifications outlined in:

    *CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493
    *CAP: College of American Pathologists (CAP): All Common, General, Director Responsibility and Authority and all test-specific checklists
    *NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5
    *ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016

    • All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD

    RESPONSIBILITIES:

    • Completes training and Competency Assessment for all new and existing procedures
    • Takes responsibility for completing continuing education requirements set by applicable regulatory and accrediting agencies
    • Performs all test realization function in support of Biodesix products and services
    • Performs duties in line with established SOP
    • Enters appropriate data into LIMS
    • Uploads appropriate data to the Customer Service team
    • Contributes to the overall maintenance of laboratory equipment and supplies following SOPs
    • Contributes to the creation and revision of Laboratory SOP in the QMS
    • Contributes to the Internal Audit readiness through good documentation practices
    • Performs all job functions in accordance with HIPAA
    • Contributes to Development projects, as needed
    • Communicates effectively with on-site and remotely located management/support teams
    • Works independently and has exceptional written and verbal skills

    COMPETENCY OR POSITION REQUIREMENTS:

    • Outstanding technical laboratory skills. Excellent attention to detail with a strong commitment to thoroughness and error-free execution of procedures
    • Exceptional organizational and documentation skills
    • Participate in CE program
    • Knowledge of lab safety
    • Basic computer skills required (Microsoft suite)
    • Ability to work well in a team environment with strong work ethic

    EDUCATION AND EXPERIENCE:

    • Bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology or equivalent laboratory training and experience meeting the requirements defined by CLIA

    UNPLANNED ACTIVITIES:

    • Other duties as assigned

    TRAVEL PERCENTAGE:

    • Minimal

    COMPENSATION:

    We are excited to provide:

    • Competitive compensation $ $28.94
    • Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.
    • Discretionary Bonus opportunity
    • Comprehensive benefits package - effective date of hire
    • Medical
    • Dental
    • Vision
    • Short/Long Term Disability
    • Life Insurance
    • Flex Spending Account
    • 401(k)
    • 120 hours of annual vacation
    • 72 hours of paid sick time off
    • 11 paid holidays
    • 3 floating holidays
    • Employee Assistance Program
    • Voluntary Benefits
    • Employee recognition program

    JOB LOCATION:

    • Louisville, CO
    Biodesix is an equal opportunity employer.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.


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