UHealth Information Technology is seeking a Computer Systems Validation Specialist (IT Project Specialist) with technical writer experience that will work in consultation with Research IT, software vendors/consultants, and regulatory compliance personnel to author validation related documentation, including standard operating procedures, requirements documents, traceability matrices, test scripts, and use cases, for systems requiring validation under FDA Part 11, HIPAA, FISMA, or other regulatory compliance framework. Familiarity with regulatory compliance, FDA Part 11, HIPAA, GxP, etc. preferred.
The individual will also produce work instructions and user guides, assemble reports, identify deficiencies in documentation, participate in the change control/change management process, and assist in user acceptance testing. For all applicable systems, the incumbent will be expected to achieve the necessary depth of knowledge and understanding of system functionality in order to produce documentation that is precise, accurate, and clear. This individual will be responsible for ensuring that validation package documents adhere to established documentation standards and that assembled validation packages are complete, organized, and audit-ready at all times. Other duties as assigned, including providing support to end users.
- Bachelor's Degree in relevant field required
- Formal project management coursework or training (preferred)
- Six Sigma Green Belt or greater (preferred)
- 4 years of relevant experience
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University of Miami School of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.