[Next-Generation Sequencing Book]
  • [Photo] Jim Davidson • June 9, 2005

    BACKGROUND

    Technical Writer with knowledge of Lab instrumentation validation

    RESPONSIBILITIES

    Lead Documentation/Validation Instrumentation



    Coordinate and manage the efforts of 4 individuals performing the following job function.

    Long term assignment to update and revalidate instrumentation, software and data acquisition and calibration.

    Use existing templates, develop standardize templates, review vendor validation procedures for all existing laboratory equipment within the organization. Experience validating and documenting using the following techniques is highly desirable:
    • IQ Installation Qualification
    • OQ Operational Qualification (including authorized access, limited access to selected functions, audit trail, data integrity, data archiving & retrieval related to 21 CFR part 11.
    • PQ to test specific critical functions
    Set up revalidation or PV Performance Validation as defined by SOP.

    Establish change control procedures.

    PREFERENCES:
    local to Boston, leadship experience on validaton project

    TERMS:
    consultant-length is approx 2 years

    LOCALE:
    Cambridge, MA

    COMPENSATION

    $60hr w2 pay rate,

    HOW TO APPLY

    email jdavidson[at]grouptechinc.com

    DEADLINE

    ASAP, need 5th person for this project

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