Research Quality Assurance and Validation Specialist

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Job Category:

Employment Type:

Job Profile:

Job Duties:

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.

Key Job Responsibilities:

• 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

Department:

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

This position is within the School of Medicine and Public Healths 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.

• 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.
• Technology Solutions:We provide technology solutions to the School of Medicine and Public Health including cybersecurity educational technology and IT support.

Compensation:

The starting salary for the position is $70000 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

Required Qualifications:

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

• Strong organizational analytical verbal and written communication skills

Preferred Qualifications:

• 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

Education:

Bachelors degree preferred

How to Apply:

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.

Contact Information:

Cody Roekle

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

Institutional Statement on Diversity:

Diversity is a source of strength creativity and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity culture background experience status abilities and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching research outreach and diversity as inextricably linked goals.

The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students faculty and staff serve Wisconsin and the world.

For more information on diversity and inclusion on campus please visit:Diversity and Inclusion

The University of Wisconsin-Madison is an Equal OpportunityEmployer.

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 backgroundsand encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings click here.

To request a disability or pregnancy-related accommodationfor any step in the hiring process (e.g. application interview pre-employment testing etc.) please contact the Divisional Disability Representative (DDR)in the division you are applying make your request as soon as possible to help the university respond most effectively to you.