Integrated DNA Technologies

  • Quality Systems Validation Specialist

    Job Locations US-IA-Coralville
    Posted Date 4 weeks ago(6/25/2018 5:01 PM)
    ID
    2018-3876
    # of Openings
    1
    Category
    Quality Assurance
    Shift/Schedule
    M-F 40 Hour Week (United States of America)
  • Overview

    The QS Validation Specialist is responsible for providing administration, technical review, and investigation activities to maintain compliance of the IDT validation program with established quality system policies and external regulations.  This role is accountable for accurate and timely review of IDT Quality Systems records related to the validation of manufacturing equipment, processes, methods, and software.  This role will also support general IDT quality systems activities including: change control, deviation, process risk management, complaints, non-conformances, and root cause investigation.

    Responsibilities

    Essential Functions:

    • Completes daily tasks associated with detailed QA review and release of validation IQ/OQ/PQ records for manufacturing processes/equipment/methods using the equipment management software system (Maintenance Connection).
    • Interacts professionally and efficiently with global manufacturing and support staff to administer risk-based change control within the electronic QMS software (Master Control).
    • Assists with root cause investigation and closure of non-conformances / complaints and actions related to the manufacture of IDT products.
    • Assists with the development and QA review of validation planning documentation to ensure compliance with IDT QA policy, ISO 9001, ISO13485, and 21CFR Part 820 FDA Quality System expectations.
    • Prepares reports of quality system performance and validation gap assessments for internal departmental use as well as management review.
    • Performs activities and tasks assigned as part of QA based improvement initiatives and projects.
    • Participates in documentation of general risk management process records including FMEA formats.
    • Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.
    • Performs other duties as assigned.

    Qualifications

    Education:

    • Bachelor’s degree in engineering or science related field (or equivalent experience) required.

     

    Professional Experience:

    • Minimum of three years of oligonucleotide manufacturing experience preferred
    • Experience and familiarity with validation requirements which are compliant with ISO:9000/13485 standards and FDA QSR/cGMP standards preferred
    • Experience and familiarity with risk-based (FMEA) investigation, validation and change control systems preferred
    • Experience and familiarity with Lean manufacturing principles preferred

     

    Other Job Qualifications

    • Strong verbal, written, analytical and persuasive skills with ability to interact effectively with all levels of employees and management.
    • Ability to learn advanced calculations and reporting with Microsoft Office applications (emphasis in Excel, Word, PowerPoint).
    • Statistical analysis, precision measurement and process capability studies will become an intricate part of quality assurance programs; therefore, formal education in courses related to these areas such as mathematics, statistics, and industrial practices, may be essential for this position.
    • Ability to perform a variety of duties, often changing from one task to another without loss of efficiency or composure
    • 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.
    • 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.
    • 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.
    • Repetitive Motion: substantial movements (motion) of the wrists, hands, and/or fingers.

    Frequent (34-66% of work day)

    • 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.

    Occasional (33% or less of work day)

    • Standing: maintaining an upright position.
    • Walking: moving about on foot to accomplish tasks.
    • 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:

    • Work requires close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
    • Ability to read pertinent printed material and distinguish colors.
    • Ability to accurately read measurements on equipment.
    • 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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