The St. Jude GMP has an exciting opportunity for a System Analyst as we transition to an fully electronic, FDA compliant environment, with GxP computerized systems meeting 21 CFR Part 11. As part of the TPQ Bio-Process Information System team, the System Analyst GMP (SA-GMP) will become a subject matter expert in the design, configuration, validation and maintenance of commercially available GxP compliant software solutions selected to meet the regulatory and business needs of the St Jude GMP Facility. The primary objective for the position will be to work with cross-functional teams to develop, implement, and support GxP compliant software applications to satisfy St Jude GMP user requirements for an Electronic Batch Record (EBR), Inventory Management (IM), and Quality Control testing and release of biotherapeutics manufactured for Phase I and Phase II clinical trials. The position and team will work closely with the Quality Assurance (QA) department to ensure GMP, GTP, and FACT compliance of the software applications. The role also involves processing system changes under change control, authoring and execution of validation document, training of end-users, and is ensuring the overall health of the electronic environment as per our Software Validation Life Cycle (SDLC) process.