Quality Assurance & Process Improvement Specialist I

Arup; Salt Lake City (UT); On-site; USD 65,000 - 90,000; Full time

Job summary

ARUP Laboratories in Salt Lake City is seeking a Quality Specialist I to support sequencing and clinical analytics. You will oversee QA/I plans, coordinate quality initiatives, and lead nonconformance investigations, CAPAs, and proficiency activities within a fast-paced laboratory setting.

The role emphasizes data trends, quality meetings, and collaboration with Technical Operations and management to uphold regulatory requirements and process excellence.

Qualifications

• Bachelor's Degree or better in Medical Laboratory Sciences or related field.
• Three years high complexity testing experience in a clinical laboratory or quality experience in a regulated environment.
• Preferred: MLS (ASCP), MT (ASCP), or related quality/certification in area(s) of responsibility.

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 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

Education

Bachelor's Degree in Medical Laboratory Sciences or related field

Job description

ARUP Laboratories in Salt Lake City is seeking a Quality Specialist I to support sequencing and clinical analytics. You will oversee QA/I plans, coordinate quality initiatives, and lead nonconformance investigations, CAPAs, and proficiency activities within a fast-paced laboratory setting.

The role emphasizes data trends, quality meetings, and collaboration with Technical Operations and management to uphold regulatory requirements and process excellence.