cGMP Validation & Oracle EBS Quality Assurance Analyst

Description Leidos is seeking an experienced cGMP Validation Quality Assurance Analyst with strong Oracle EBS testing experienceto support the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Strategic National Stockpile (SNS).Contingent upon contract awardCandidate MUST: Be a US Citizen or Green Card holder with the ability to obtain a Public Trust Clearance. Role is remote but MUST be located in the UNITED STATES preference for candidates who are local to the Atlanta, GA areaPosition Summary The successful candidate will support validation and quality assurance for mission-critical Oracle E-Business Suite (EBS) systems supporting inventory, supply chain, asset management, financial, and warehouse operations. The analyst will ensure system changes meet applicable cGMP, 21 CFR Part 11, HHS, SNS, and system-development requirements while planning and executing functional, integration, regression, and user acceptance testing for Oracle EBS applications. The SNS mission depends on 24x7 availability of systems that support the nation's emergency medical supply readiness and public health response. This position will participate in on-call services and must be able to acknowledge critical incidents within 15 minutes while on call.Primary ResponsibilitiesLead and support cGMP computerized-system validation activities for Oracle EBS applications and enhancements. Develop and maintain validation plans, requirements traceability, test protocols/scripts, validation evidence, deviation records, and validation summary documentation. Ensure system changes comply with applicable cGMP, 21 CFR Part 11, SNS change-control, and validation requirements. Integrate validation activities and evidence into Agile development iterations and release processes. Review requirements, user stories, acceptance criteria, functional designs, configurations, and changes for testability and validation impact. Develop and execute te