Quality Specialist I, Testing Support - Anatomic Pathology

ARUP Laboratories

  • Salt Lake City, UT
  • 30+ days ago

    Highlights

    Initiates non-conformances, Report and Learn (RL) events, or MasterControl (MC) deviations as appropriate (may require technical operations' assistance for support departments with high volumes of non-conformances). Supports the associated laboratory's nonconformance investigations (root cause analyses) and corrective and preventive actions (CAPAs).

    Numbers & Facts

    LocationSalt Lake City, UT

    Description

    Schedule:

    Monday - Friday (40 hrs/wk)

    8:00 AM - 4:30 PM

    Department: Quality Systems & Support - 252

    Primary Purpose:

    Provides services of a quality nature. Participates in the development of Quality Assurance/Improvement (QA/I) plans for associated technical areas. Oversees and coordinates quality assurance activities for the group(s). Supports the associated laboratory's nonconformance investigations (root cause analyses) and corrective and preventive actions (CAPAs). Evaluates and supports that problem solving and corrective actions are thorough, timely, complete, accurate, and effective. Facilitates the proficiency testing and indicator processes within the areas of support. Evaluates compliance with all associated policies, procedures, and regulations and communicates status to laboratory management and Quality Systems & Support management. Leads quality-focused process improvement activities.

    About ARUP:

    ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

    ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient's life. We never forget that there is a patient behind every specimen we receive.

    We are looking for individuals who want to contribute to ARUPs culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

    Essential Functions:

    Facilitates quality improvement initiatives. Capture priorities in annual Quality Specialist fiscal year plan

    Functions as trainer/facilitator for process improvements

    Prepares annual QA/I plan

    Coordinates with Technical Operations leadership on support and prioritization of quality initiatives

    Trends/interprets data and facilitates QA discussion within laboratories' monthly quality meetings

    Prepares minutes from monthly QA meetings for circulation by DCS

    Together with department staff, investigates out of threshold quality metrics

    Initiates non-conformances, Report and Learn (RL) events, or MasterControl (MC) deviations as appropriate (may require technical operations' assistance for support departments with high volumes of non-conformances)

    Functions as nonconformance/RL/MC deviation - evaluator/responder OR reviewer (at least one)

    Facilitates Root Cause Analysis

    Facilitates CAPAs

    Evaluates minor nonconformances, RLs, MC deviations, and/or variances for trends

    Facilitates the updates and ensure accuracy through the annual review of the Quality Task Matrix, Medical Director Criteria Form and other quality documents

    Initiates/oversees the mislabel/suboptimal/pending challenge where applicable

    Provides suggestions for quality-related procedure updates. May serve as a document collaborator or author where appropriate

    Presents quality-related education to area staff meetings

    Prepares/presents client quality issues for weekly/monthly review meetings for ARUP leadership

    Provides Quality training to new supervisors as part of ARUPs new leader training

    Gathers lab specific data for Quality Steering Committee decision making

    Is involved in Pathology Review and Consensus (PaRC), where appropriate for areas of support

    Develops/coordinates mock inspections within areas of support, as appropriate

    Performs audits as part of the internal audit program

    Supports the proficiency testing programs and activities for labs; completion, coverage, records. May participate in PT Annual Ordering event

    Initiates PT Problem Reports - review, approval and follow up

    Supports labs during assessments/inspections/surveys from CAP, NY, FDA, AABB, California, ISO 15189, and other regulatory agencies

    Acts as a liaison as needed to assist with responses to accreditation deficiencies and/or gaps

    Reviews instrument correlation studies, where appropriate

    Develops instrument validation and re-validation/verification plans for instruments and equipment, as appropriate

    Evaluates and maintains corporate equipment verification plans and corresponding procedures

    Reviews/approves instrument/equipment validations (IQ/OQ/PQ)

    May review QC Summary report for completion, if applicable

    Other duties as assigned

    Physical and Other Requirements:

    Stooping: Bending body downward and forward by bending spine at the waist.

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

    Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

    Communicate: Frequently communicate with others.

    PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.

    ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

    Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.

    Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

    Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as making general observations of depth and distance.

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