Molecular Technologist I - Cambridge, United States - Foundation Medicine

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    Full time
    Description

    About the Job

    The Molecular Technologist I performs procedures in a complex patient sample testing process with
    limited supervision. Most prominently, the position is responsible for solution and reagent
    preparation, equipment maintenance, and the handling and testing of patient specimens. The
    incumbent works one of three established shifts and may be assigned to work any day that the lab is
    operational.


    This is a regulated position and additional information may be available from QA on the qualifications
    for this role pertaining to regulatory guidelines.


    Regular onsite work at a designated FMI location is an essential function of this role.

    Key Responsibilities:


    • Prepare the Next Generation Sequencing (NGS) library.

    • Under limited supervision of senior lab personnel and in adherence to established Standard
    Operating Procedures (SOPs):
     Extract and isolate nucleic acids.

     Complete hybridization capture, and genetic sequencing methods.
     Operate automated 8-span and 96-head liquid handling platforms.
     Operate quantification, sizing, and NGS instruments.
     Perform any other patient and client sample testing and processing steps needed.

    • Perform workflow that maintains quality, thoroughness, and optimum efficiency for Turn Around
    Time (TAT).

    • Utilize the Laboratory Information Management System (LIMS) to track and execute sample
    processing.

    • Document executed process steps per Good Documentation Practices (GDP).

    • Update and maintain records and data on test results per GDP.

    • Perform daily, weekly, monthly and as needed equipment maintenance checks.

    • Participate in additional continuous quality improvement activities.

    • Adhere to safety protocols, such as wearing laboratory coats and required safety gear.

    • Maintain organization and cleanliness in the labs.

    • Collaborate on SOPs revisions and drafts as needed to adjust for process improvement initiatives
    and regulatory changes.

    • Review SOPs at set intervals and sign-off to document knowledge of these procedures.

    • Document and assist with investigations for non-compliance events via Non-Conformance Reports
    (NCRs), Corrective Action/Preventative Action (CAPAs) and other reports.

    • Other duties as assigned.

    Qualifications:

    Basic Qualifications

    • Bachelor's Degree in a chemical, physical, biological, or life science (per NYSDOH regulatory
    requirements)

    • 1+ years of molecular laboratory work experience in a CAP/CLIA regulated lab

    • Certifications or licensure that is required by the state or county in which the job is posted.


    Preferred Qualifications

    • Molecular Biology American Society of Clinical Pathology (MB-ASCP) Certification

    • Quality System Regulations (QSR) compliant laboratory experience

    • Familiarity of and experience working with DNA manipulation techniques, enzymatic reactions, and
    sequencing chemistry

    • Familiarity with high throughput platforms and common molecular laboratory equipment (such as
    pipettes, thermocyclers, and liquid handlers)

    • Experience with Laboratory Information Management System (LIMS)

    • Experience ensuring and maintaining integrity and quality of the laboratory in the areas of sample
    processing, equipment maintenance, and SOPs

    • Knowledge about laboratory safety protocols

    • Demonstrated ability to:
     Work well under pressure while maintaining a professional demeanor both as an individual contributor and in a team
     Prioritize and thoroughly follow up on assigned tasks
     Handle multiple tasks at once and work in a fast-paced environment
     Adapt to changing procedures, policies and work environment
     Work in the presence of chemicals and reagents in a laboratory environment

    • Proficiency utilizing Microsoft Office Suite, most specifically Excel and Power Point

    • Excellent skills of written communication, oral communication, collaboration, and problem solving
    with other departments and colleagues

    • Excellent organization and attention to detail

    • Understanding of HIPAA and importance of patient data privacy

    • Commitment to reflect FMI's Values: Patients, Passion, Collaboration, and Innovation.

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