IDT - Coralville Operations (1710 Commercial Park)

  • Quality Systems Software Administrator

    Job Locations US-IA-Coralville
    Posted Date 2 months ago(5/30/2019 9:51 AM)
    ID
    2019-4829
    # of Openings
    1
    Category
    Quality Assurance
    Shift/Schedule
    M-F 40 Hour Week (United States of America)
  • Overview

    The QS Software Administrator is responsible for ensuring production software validation records are compliant with current regulatory standards and are maintained according to IDT Quality System policies. The key areas of responsibility include maintenance of IDT software compliance program to generate compliant software validation records to be used during audits, to provide general guidance as well as support for software validation across all IDT locations, and administration support of IDT EQMS and supporting software.

    Responsibilities

    • Monitor, maintain, and improve IDT Quality Systems software validation compliance program
    • Provide guidance to business analysts, software developers, and process owners to achieve software validation compliance to ISO 13485 and cGMP expectations
    • Lead efforts for maintenance, upgrades, and validation testing of EQMS (Master Control)
    • Support and training for EQMS system administration
    • Support EQMS leads for advanced reporting and data processing
    • Support and maintenance of Office 365 SharePoint with advanced reporting
    • Provide quality assurance review and guidance for software compliance as part of IDT improvement projects
    • Developing SOPs, Process Flows, and Work Instruction level documentation
    • Demonstrates behavior consistent with the Integrated DNA Technologies Core Values
    • Performs other duties as assigned

    Qualifications

    Education:

    • Bachelor’s degree required.

    Professional Experience:

    • Microsoft Office 2016 with advanced Excel data reporting required
    • SharePoint 365 preferred
    • Previous experience with ISO 13485 and cGMP validation requirements preferred

    Other Job Qualifications

    • Ability to make plans and working independently to implement change effectively
    • Ability to communicate clearly and professionally with internal and external customers
    • Ability to make decisions using available resources and sound judgment
    • Ability to work effectively as part of a team to achieve established outcomes
    • Ability to perform a variety of duties, often changing from one task to another without loss of efficiency or composure.
    • Ability to maintain both a high standard of courtesy and cooperation in dealing with co-workers.
    • Ability to accept responsibility for the direction, control or planning of an activity.
    • Adaptability to situations requiring the precise attainment of set limits, tolerances or standards.
    • Ability to perform repetitive work or to perform continuously the same work, according to set procedures sequence or pace.

    Travel Requirements (anything requiring an overnight stay):

    • Seldom (Up to 5% of time)

    Physical Requirements:

    Exert up to 10 lbs. of force occasionally and/or up to a minimal amount frequently

    Constant (67%-100% of work day)

    • Reaching: extending hand(s) and arm(s) in any direction.
    • Sitting: to assume a position in which the weight is largely supported by the buttocks, usually with the body vertical and the thighs horizontal.
    • Talking: expressing or exchanging ideas by means of the spoken work- those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
    • Repetitive Motion: substantial movements (motion) of the wrists, hands, and/or fingers.

    Frequent (34-66% of work day)

    • Hearing: perceiving the nature of sounds at normal range; ability to receive detailed information through oral communication, and to make fine discriminations in sound, such as when auscultating and percussing.

    Occasional (33% or less of work day)

    • Standing: maintaining an upright position.
    • Walking: moving about on foot to accomplish tasks.
    • Using Fingers/Grasping/Feeling: writing or otherwise working, primarily with fingers rather than with the whole hand or arm as in handling. Applying pressure to an object with the fingers or palm and perceiving attributes of objects such as size, shape, temperature or texture by touch.
    • Lifting: raising objects from a lower to a higher position or moving objects horizontally from position to position.
    • Bending: bending body downward and forward by bending spine at the waist and/or bending leg; bending legs at knee to come to rest or kneel.
    • Pushing/Pulling: using upper extremities to press against something with steady force in order to thrust forward, downward or outward/using upper extremities to exert force in order to drag, haul, or tug objects in a sustained motion.
    • Climbing: stairs, stools, ramps, ladders. 

    Visual Acuity:

    • Ability to read pertinent printed material and distinguish colors.
    • Ability to prepare and read written documentation; use of computer.

     

    Integrated DNA Technologies is an equal employment and affirmative action employer. Minorities, women, veterans and individuals with disabilities are encouraged to apply.

     

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