Quality Specialist I, Testing Support Molecular Division

Schedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 4:30 PM

Training Schedule:
Monday - Friday (40 hrs/wk)
7:30 AM - 4:00 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 laboratorys 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 patients 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.

Required Experience:

IC