Validation Specialist II

ARUP Laboratories • Salt Lake City, UT • 3h ago

Description

Schedule :Monday - Friday (40 hrs/wk)8:00 AM - 4:30 PM

Department: IT Clin Validation Sup - 815

Primary Purpose :

Information Technology - Clinical Validation Support: Supports ensuring all clinical laboratory tests are configured and performing according to defined expectations within related test systems. Supports implementing and coordinating LIS test validation activities in conjunction with the laboratory and other IT departments. Supports providing best practices that promote reliability, quality, and compliance with regulations.

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, works independently on moderately complex tasks/projects with moderate direction, consulting with senior peers to support efforts to:

Plan, create, manage, and assist in executing validation activities.

Collaborate with other IT departments and the laboratory validation owner in the development, review, and delivery of validation plans/protocols.

Create, edit, review, and maintain validation documentation including but not limited to best practice and guide documents, templates, specifications, acceptance criteria, test protocols, and validation summary reports.

Provide consistency in the validation approach and performance of processes and procedures.

Coordinate with validation owner to ensure validation is conducted appropriately.

Troubleshoot and investigate validation related issues.

Participate in cross-functional groups to solve problems.

Monitor and report on validation activities.

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.

Qualifications

Education

Required

High School Diploma or Equivalent or better

Preferred

Associates Degree or better in Engineering

Experience

Required

Associate's Degree or college level course work in Medical Laboratory Science or related science, IT, engineering, healthcare, or business and one (1) year experience in the healthcare or IT industry and one (1) year experience in writing and performing software or process validations in a regulated environment OR High School diploma or equivalent and two (2) years of experience in writing and performing software or process validations in a regulated environment

Preferred

Previous software and/or process validation experience

Clinical laboratory experience

Project experience

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.

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