ARUP Laboratories · 1 month ago
Quality Specialist I, Testing Support
Salt Lake City, UT
Full-time
Onsite
Mid Level
3+ years expARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. The Quality Specialist I role involves providing quality assurance services, overseeing quality assurance activities, and supporting laboratory investigations and compliance efforts.
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
Bachelor's Degree or better in Medical Laboratory Sciences or related field
Bachelor's degree in Clinical or Medical Laboratory Science, Medical Technology or in the chemical or biological sciences and three years high complexity testing experience in a clinical laboratory or quality experience in a regulated environment
Preferred
Combination of high complexity clinical laboratory experience and quality experience in a regulated environment
ASCP certification in area of support (MLS or Molecular Biology)
Quality-focused certification such as ASQ belt
Master's degree
Applicable ASQ
Company
ARUP Laboratories
ARUP Laboratories is a research and development laboratory that provides laboratory operations and system laboratory alignment solutions.
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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