Schedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM
Department: IT Clin Validation Sup - 815
Primary Purpose:
Information Technology – Clinical Validation Support: The IT Clinical Validation Support Supervisor leads the team, is responsible for ensuring all clinical laboratory tests are configured and performing according to defined expectations within related systems. Oversees the daily activities of the validation engineers, specialists, and support specialists. Provides support and knowledge to the team. Works closely with departments and leadership to coordinate Technical Operations Validation resources in a manner that supports corporate priorities and customer needs. Directs the work of individuals with diverse responsibilities and expertise.
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:
Information Technology – Clinical Validation Support:
Pertaining to LIS Tests:
Responsible for operations of the department utilizing available resources to ensure reliable services.
Plans, manages, and prioritizes validation activities.
Collaborates with the laboratory validation owner in the development and delivery of validation protocols.
Creates, edits, reviews, and maintains validation documentation including but not limited to best practice and guide documents, specifications, acceptance criteria, test protocols, and validation summary reports.
Acts as a subject-matter expert to provide consistency in the validation approach and defining policies, processes, and procedures.
Provides project management and resource coordination as needed to ensure validation is conducted appropriately.
Coordinates and ensures validation is conducted appropriately.
Provides training on validation best practices and on specific ARUP validation policies, processes, and procedures to IT departments, Technical Operations, and other departments as needed.
Troubleshoots and investigates validation related issues.
Identifies and resolves non-conformances and deviations.
Contributes to documentation of data and process flow diagrams of the total test process.
Promotes total test process validation best practices.
Participates in cross-functional groups to solve problems.
Monitors and reports on validation activities.
Acts as a contact for technical supervisors, IT, and Quality to triage validation related issues, as needed.
Prepares annual financial budget and manages expenditures against the approved budget.
Develops and maintains departmental policies, procedures, and QA measures.
Prepares annual strategic plan and goals, and reports progress.
Responsible for hiring, training, mentoring, counseling, and engagement of direct reports including terminating employment when needed.
Conducts annual reviews for direct reports, promotes employee engagement.
Tracks, monitors, approves, and enforces time and attendance policies.
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.
Required
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Bachelor’s degree in a Laboratory Science, Information Technology, Engineering or related field
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Two (2) years of leadership experience in a supervisory, lead, or engineer role
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Six (6) years of experience in a clinical laboratory or regulated environment
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Two (2) years of previous software and/or process validation experience in a regulated environment
Preferred
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Project experience
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Technology transfer experience
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Experience implementing and/or configuring a Laboratory Information System (LIS) or a Laboratory Information Management System (LIMS)
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Working knowledge of GAMP principles
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Understanding of 21 CFR Part 11
Required
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Bachelor's Degree or better in Laboratory Medicine and Biomedical Science or related field
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
