Integrated DNA Technologies

  • Quality Specialist

    Job Locations US-IA-Coralville
    Posted Date 1 week ago(1 week ago)
    ID
    2018-3974
    # of Openings
    1
    Category
    Quality Assurance
    Shift/Schedule
    M-F 40 Hour Week (United States of America)
  • Overview

    The Quality Specialist is responsible for providing administration of key components of the Quality Management System.  This may include but is not limited to document control, audit, training or process control functions.  

    Responsibilities

    Essential Functions:



    • Reports to the Manager of Quality Systems and is responsible for coordinating and maintaining key components of the Quality Management System

    • Maintains records and processes for document handling, audit, process controls (NCR/Deviation/CAPA) and training – may participate in several aspects.

    • Interacts professionally and efficiently with manufacturing and support staff: administrates /supports the intra-department functionality of the QMS with departments throughout IDT.

    • Prepares reports of quality system performance for internal departmental use, as well as management review.

    • Serves as a member of internal audit teams for execution of audits at the Coralville location, as needed.

    • Assists in developing content for and delivering training on various quality systems functions such as NCR’s, deviations, document control, training system administration, and validation activities.

    • Participates in customer and third-party audits, as needed.

    • Assists with the development and implementation of responses for customer, regulatory and certifying body audits, as needed.

    • Performs other duties as assigned.

    Qualifications

    Education:



    • Bachelor’s degree in a related field required.


    Professional Experience:



    • Previous professional quality assurance experience in manufacturing industry preferred

    • Experience and familiarity with ISO:9000/13485 standards and FDA QSR/cGMP standards, strongly preferred


    Other Job Qualifications



    • Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management.

    • 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 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.


    Physical Requirements:


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


    Constant (67%-100% of work day)



    • 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.


    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.

    • 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.


    Occasional (33% or less of work day)



    • Reaching: extending hand(s) and arm(s) in any direction.

    • 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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed