Quality Assonance Specialist / Software Test EngineerWe are currently looking for a Quality Assonance Specialist / Software Test Engineer with experience verifying and validating software solution governed by cGMP requirements.
Experience with Oracle EBS Application is a must. The project supports a critical national security mission. You will certainly find purpose with your work.The successful candidate will serve as the cGMP Quality & Validation Specialist supporting a re-implementation of an existing on-premise Oracle ERP installation to Oracle Cloud Infrastructure. The Oracle EBS is a large, complex Financial and Supply Chain implementation supporting Department of Human and Health Services. The project will cover, among other areas, Project Management, Technical architecture and cloud infrastructure, Core ERP implementation, Analytics and business intelligence configuration, Data migration, Warehouse interface implementation, and Current Good Manufacturing Practices (cGMP) validation. You will be a key contributor to ensure the Oracle EBS based product meet the functional requirement specifications and cGMP requirements. Ultimately, our team reduces costs and supports innovation to streamline the financial and supply chain operations of a critical public health mission. The candidate can be located anywhere in the U.S. with no travel expected but must be able to work during Eastern Time Zone.EDUCATION & EXPERIENCE:A Bachelor’s degree and 5 years of software testing experience and 3 years in Oracle eBusiness Suite3 or more years of cGMP experience for validation of computer systems in a pharmaceutical company or in a computer validation companyGood knowledge of 21 CFR Part 11 Electronic Records and Electronic Signature21 CFR Part 820 Quality Management system21 CFR Part 210 & 211 Good Manufacturing PracticesKnowledge of validation based on SDLC (System Development Life Cycle)Knowledge of Good Documentation PracticesKnowledge of Change ManagementHas experience of developing and executing test scripts and other validation documents such as Functional Requirement Specifications and Traceability Matrix.