Portage, Michigan, United States
Quality Specialist: Validation, UAT, Business Analysis, Project Management, Computer System Validation, Computer Software Assurance Experienced with requirement elicitation, developing, documenting, and managing validation and user acceptance testing across multiple product platforms. Specifically computer software systems, laboratory equipment, medical devices and ERPs. Ad hoc PM to help facilitate project progression and completion as needed.
Provide client support for the computer system validation life cycle with emphasis on computer software assurance principles
Plan, design, research, elicit, write, and edit User Requirement Specifications and Functional Requirement Specifications for the in-house and SaaS database software platforms for data analytics. Requirement elicitation Bridge between business and IT Process workflows Project Management Documentation: User Requirements Functional Requirements Product Design Specification Traceability Matrix
Lead validation activities for configuration of clinical trial databases utilizing Medidata RAVE and Oracle Inform software platforms. Risk assessment Develop testing strategy Issue reporting and resolution Project management Documentation: Requirements/Specifications Test Plans Test Scripts Trace Matrix Summary Report