The cGMP Validation & Oracle EBS Quality Assurance Analyst joins the team to support mission-critical Oracle E-Business Suite systems managing inventory, supply chain, asset management, financial, and warehouse operations. The analyst ensures system changes comply with cGMP, 21 CFR Part 11, and specific federal requirements while performing functional, integration, regression, and user acceptance testing. Daily responsibilities include developing validation plans, requirement traceability matrices, test protocols, and summary documentation within Agile development cycles. The role involves translating user stories into executable scripts, documenting defects, and coordinating with developers and stakeholders to ensure release readiness. Key technical competencies include extensive experience in computerized-system validation, Oracle EBS applications, and automated testing tools. This position addresses the critical need for 24/7 system availability to support emergency medical supply readiness and public health response infrastructure.
System Test
Validation
pre‑silicon planning
post‑silicon validation
SoC
GPU
high‑volume manufacturing
Product Development
Office
Windows OS
Quality Metrics