ARUP Laboratories · 1 month ago
Quality Specialist I, Testing Support
Salt Lake City, Utah, United States
Full-time
Onsite
New Grad, Entry LevelARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah. The Quality Specialist I, Testing Support role involves providing quality assurance services, overseeing quality assurance activities, and supporting laboratory compliance and process improvement initiatives.
Biotechnology
Responsibilities
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 ARUP's 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
Qualification
Required
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
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
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 ARUP's 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
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
Company
ARUP Laboratories
ARUP Laboratories is a research and development laboratory that provides laboratory operations and system laboratory alignment solutions.
Founded in 1983
1001-5000 employees
H1B Sponsorship
ARUP Laboratories has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (147)
2024 (75)
2023 (98)
2022 (155)
2021 (72)
2020 (52)
Funding
Current Stage
Late StageTotal Funding
$3MKey Investors
Health Resources and Services Administration
2023-01-10Grant· $3M
Leadership Team
Kent Gordon
CFO
Alex P.
Talent Acquisition Partner
Recent News
2025-10-28
Medical Xpress - latest medical and health news stories
2025-10-23
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