Job Information
ARUP Laboratories IT Quality Analyst in Salt Lake City, Utah
Description
Schedule :Monday - Friday (40 hrs/wk)8:00 AM - 5:00 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 Information Technology. Coordinates quality system activities for the IT group(s). Supports IT division nonconformance investigations (root cause analyses) and corrective and preventive actions (CAPA’s). Evaluates and supports that problem solving and corrective actions are thorough, timely, complete, accurate, and effective. Evaluates compliance with all associated policies, procedures, and regulations and communicates status to IT management and Quality Systems & Support management. Identifies and partners on potential 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 ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.
Essential Functions :
Functions as nonconformance – evaluator/responder and/or reviewer (minimally either a responder or reviewer, preferably able to serve any of the roles)
Supports, educates and trains IT designees on the roles and responsibilities for responding to nonconformance quality action requests (QARs)
Serves as a liaison between IT and Technical Operations for resolving nonconformances
Assists in assessing and enhancing IT quality programs
Reviews monthly QA summary reports and reports trends to IT and Quality management
Evaluates and assists in development and maintenance of corporate Information Technology procedures as they relate to the Quality Management System
Assists in conducting 21CFR Part 11 assessments, as needed
Supports monthly IT division QA meetings per direction by the Director of IT Business Planning (includes collecting and preparing Salesforce nonconformance data)
Performs and authors root cause analysis investigations for IT-related major nonconformances
Facilitates CAPAs and Effectiveness Checks
Trains IT designees as CAPA task owners and how to navigate the CAPA system
Develops audit tools and performs audits
Supports process improvement activities as directed by Quality and IT leadership
Provides quality related guidance for department procedure updates upon request
Presents IT-related client QA issues at weekly/monthly review meetings
Initiates nonconformances in either the POB or enterprise nonconformance systems
Establishes and maintains open and effective communication as required with and between IT groups, Quality and Tech-ops
Attends IT meetings as a quality liaison
Supports IT during assessments/inspections by CAP, FDA, NY, California, ISO, other regulatory agencies, and CRO audits
Serves as support for Quality Corporate Programs functions as time allows and at management’s discretion
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 make general observations of depth and distance.
Qualifications
Education
Required
- Bachelor's Degree or better
Preferred
- Master's Degree or better
Experience
Required
Bachelor’s degree in Science, Information Technology, Healthcare or Business
4 years of healthcare information systems or quality experience in a regulated environment
At least 2 years of experience in application administration, software development or other direct information technology experience or quality experience in software validation, as a software quality auditor, or equivalent
Preferred
Advanced written and verbal communication skills
Strong attention to detail
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)