Research Quality Assurance and Validation Specialist

The University of Wisconsin-Madison School of Medicine and Public Health (SMPH) is embarking on an exciting mission of establishing state of the art data and informatics infrastructure to support cutting edge biomedical research. We are seeking a Research Quality Assurance (QA) and Validation Specialist to lead software validation efforts for FDA regulated projects. This position will work with research teams to define user requirements and write test cases to validate research projects.

It is anticipated that this position will be remote and requires work be performed at an offsite, non-campus work location.

• Performs analyses and prepares reports to ensure that programs meet or exceed schedule commitments

• May work with external vendors or service providers

• Determines and recommends programs required for optimal problem solution within cost/performance objectives

• Trains, serves as a resource, and provides guidance to other IT business analysts on routine problems, work processes, and policies

• Formulates and defines systems scope and objectives through research and fact-finding combined with an understanding of applicable business systems and industry requirements

• Participates in requirements planning and feasibility determination

• Works on tasks including project or functional requirements, functional design, functional configuration, testing, and documentation

• Devises or modifies moderately complex information systems including analysis of business and user needs, documenting requirements, and revising existing system logic difficulties as necessary

• Leads and executes validation for software and projects to maintain FDA 21 CFR Part 11 compliant systems

School of Medicine and Public Health, Office of Informatics and Information Technology, Applications Support.

This position is within the School of Medicine and Public Health's Office of Informatics and Information Technology (IIT). IIT is a multidisciplinary team of data scientists, engineers, developers, and IT support staff. We offer a variety of Informatics and IT services to departments and research staff within the School of Medicine and Public Health and beyond to support the conduct of high-quality clinical and translational research.

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  Informatics: We provide innovative solutions and training for a broad spectrum of clinical and translational research utilizing real-world data to facilitate rapid translation of research findings into clinical practice, with an emphasis on precision medicine, healthcare delivery, and population health.
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  Technology Solutions: We provide technology solutions to the School of Medicine and Public Health including cybersecurity, educational technology, and IT support.

The starting salary for the position is $70,000 but is negotiable based on experience and qualifications.

Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. For more information, refer to the campus benefits webpage and the SMPH Academic Staff Benefits Flyer

• Minimum two years of systems experience in software support, development or testing

• Strong organizational, analytical, verbal and written communication skills

• Experience writing system documentation and standard operating procedures

• Experience with REDCap data collection system

• Experience performing research data collection and data management

• Experience gathering user requirements and writing test cases

• Experience working in GxP environment or validation work to meet 21 CFR Part 11 requirements

Bachelor's degree preferred

To apply for this position, please click on the "I am a current employee" button or "I am not a current employee" button under Apply Now. You will be prompted to upload the following documents.

• Cover Letter
• Resume

Please note, there is only one attachment field. You must upload all of your documents in the attachment field.

Applicants are to submit a cover letter and resume detailing their training and experience relating to the required and preferred qualifications referenced above. The application reviewers will be relying on written application materials to determine which qualified applicants will advance in the recruitment process. We will notify selected applicants to participate further in the selection process directly. References will be requested of final candidates. All applicants will be notified after the search is complete and a candidate has been selected.

Cody Roekle, croekle@wisc.edu 608-263-7676

Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

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The University of Wisconsin-Madison is an Equal Opportunity Employer.

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, click here.

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