Gregory Harris Email & Phone Number

Indianapolis, Indiana

Responsible for managing validation deliverables and compliance with regulations and procedures for an advanced technology initiative.

Indianapolis, Indiana Area

Provided business analysis, quality assurance testing, test management, and project leadership skills for an automotive finance corporation and a medical device company. AFC, Business Transformation ProjectProvided business analysis and project leadership skills for an automotive finance corporation as part of a major initiative to transform its current business processes into a distributed, cloud-centered, microservices model. Worked closely with client subject matter experts and… Show more Provided business analysis, quality assurance testing, test management, and project leadership skills for an automotive finance corporation and a medical device company. AFC, Business Transformation ProjectProvided business analysis and project leadership skills for an automotive finance corporation as part of a major initiative to transform its current business processes into a distributed, cloud-centered, microservices model. Worked closely with client subject matter experts and system architects to document both the current state and proposed future state of the transformation, providing advice and expertise throughout. Provided business and process analysis of company-wide business areas. Documented current state business processes using process flow diagrams. Helped design future state processes using microservices model. Advised client on process design and optimization and advocated for the future state.Cook Medical, Computer System Validation ProjectApplied quality assurance testing expertise and project leadership skills for a life science industry client of a business management and information technology company. Provided business analysis and quality assurance consulting for a warehouse management software suite and an internally developed application. Provided business and process analysis and recommended requirements enhancements. Tracked and reported project metrics for development and execution of more than 100 test cases. Wrote and executed validation test cases for a warehouse management software suite. Helped proctor test execution and provided documentation and regulatory guidance. Provided project management support for test case creation and execution metrics.Internal Staffing ProjectScreened and interviewed prospective applicants for a major client staffing effort. Show less

Indianapolis, Indiana Area

Developed a Master Test Strategy for an SAP upgrade project at a major state university, serving as client contact in development of business relations. Developed test cases, risk analyses, business process proposals, and testing scenarios for the release of a state Medicaid management software project, and tested security configuration and functionality of a newly developed state social services enterprise software platform.

Led the Quality Assurance effort for big data project management dashboard applications for a clinical research company, a Web-based student enrollment application database for a statewide community college, and an internal project to create a mobile employee engagement application. Internal CSpring, Mobile Application ProjectLed the Quality Assurance effort for the development of a mobile application from an internal company app to publicly released software. Participated in… Show more Led the Quality Assurance effort for big data project management dashboard applications for a clinical research company, a Web-based student enrollment application database for a statewide community college, and an internal project to create a mobile employee engagement application. Internal CSpring, Mobile Application ProjectLed the Quality Assurance effort for the development of a mobile application from an internal company app to publicly released software. Participated in sprint planning sessions. Identified and implemented solution for load testing using Apache JMeter automated testing software. Wrote and executed regression testing plan. Ivy Tech, Nursing Application Web PortalLed the Quality Assurance effort for the development of a Web-based application to accept and evaluate applications to the school’s nursing programs statewide. Served as Site Lead, ensuring good client relations.Researched, developed, and executed test cases to ensure application met program requirements. Identified defects and assisted with troubleshooting. Coordinated user acceptance testing. Mentored and provided expert guidance to client leadership and project team members; ensured good client relations. INC Research, Project Manager DashboardLed the Quality Assurance effort for the development of an event-based dashboard data platform and visualization project using Agile Project Management Methodology and Hadoop, based on the integration of multiple source systems data. Played vital role in client relations for a major project for a key new client. Created computer system quality strategy and testing plans. Validated SQL queries against various source databases, conversion of results into a common event format, and storage of the events in an event database. Wrote requirements and use case documentation and created requirements traceability matrix.Helped coordinate worldwide user feedback and develop user acceptance test plan. Show less

Indanapolis

Responsible for assisting the UAT Lead for a global Laboratory Information Management System software upgrade, maintaining a consistent process for user and SME support in the testing process, providing direction and consultation to script authors, reviewing test scripts, monitoring the UAT schedule, writing Test Summary Reports and compiling post-execution documentation, sharing best practices, coordinating with functional departments and supporting changes to the software.

Indianapolis, Indiana Area

Developed commissioning and qualification protocols for deployment of packaging serialization equipment for Eli Lilly and Company, a Fortune 500 global pharmaceutical firm in Indianapolis, participated in deployment commissioning and qualification activities, wrote validation deliverables, tracked & approved defect reports and change requests; created Factory Acceptance Test for a powder filling automation system for Mead Johnson & Company, in Holland, MI.

Developed and reviewed computer system validation testing documentation for a specialized software engineering firm providing custom software to the FDA-regulated medical device market, created and tracked software defects in Test Track Pro, executed computer system validation test cases and documented deviations.

Indianapolis, In

Provided strategic quality consultation and leadership for the validation and testing of IT processes and applications for Eli Lilly and Company. • Developed testing strategy and requirements for a mission-critical European physician payment transparency reporting process• Reviewed and approved deliverables and led risk management sessions for a computer system validation of software supporting a remotely controlled robotic chemistry lab• Reviewed and approved computer system… Show more Provided strategic quality consultation and leadership for the validation and testing of IT processes and applications for Eli Lilly and Company. • Developed testing strategy and requirements for a mission-critical European physician payment transparency reporting process• Reviewed and approved deliverables and led risk management sessions for a computer system validation of software supporting a remotely controlled robotic chemistry lab• Reviewed and approved computer system testing of a Web-based internal document storage and tracking site • Identified process gaps, provided guidance for compliance with applicable regulations and recommended improvements • Participated in project planning and scheduling and conducted risk management sessions; identified key validation deliverables • Functioned in leadership role for client and peers to develop solutions and rationales for testing and business processes and acted as advocate for continuous improvement and quality in business processes and IT systems• Developed deliverables, conducted reviews and provided leadership to ensure team members’ adherence to tight project timelines Show less

Indianapolis, Indiana Area

Developed and reviewed computer system validation testing documentation for a specialized software engineering firm providing custom software to the FDA-regulated medical device market, created and tracked software defects in Test Track Pro, executed computer system validation test cases and documented deviations.

Provided consultation for a Fortune 500 Pharmaceutical Company and a Fortune 500 Medical Device Company in Indiana, major Medical Device Companies in New York, Indiana, Michigan, Ohio and California, a biologics company in Massachusetts, and a major Nutritionals Company in Michigan. Served as Site Lead, responsible for coordination between company, clients and consultants, including project management and client relations duties, on several occasions.

Developed validation documentation for a Fortune 500 pharmaceutical company, performed gap analysis and developed Computer Systems Quality action plans and remediation activities, conducted training classes, evaluated and developed operating procedures, designed document templates, and assisted with software migration.

Bachelor Of Arts, Political Science

Activities and Societies: Worked four years on student newspaper, The Louisville Cardinal, culminating as arts section editor and member.

High School Diploma