IBM Watson Health - QA Engineer - Pharmaceutical in Austin, Texas

*New hires can join in Rochester, MN; RTP, NC; Cambridge, MA; North Castle, NY *The newly formed IBM Watson Health business unit seeks talented individuals destined to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity. The convergence of data and technology is transforming healthcare and life sciences organizations in every way. New roles are being created that never existed before to meet the demands of this transformation.Quality Assurance Engineers with Clinical / Pharma experience are encouraged to work "where you can help change the world".The Quality Assurance Engineer works with the Quality Assurance and Test Development staff to author Validation/SDLC Documentation including Validation Plans/Summaries, Test Plans/Summaries, Test Matrices, etc. in order to verify that systems are performing as expected. ESSENTIAL JOB FUNCTIONS

  • Should have a diverse knowledge of GCP regulations and other regulatory guidance documentation as it applies to appropriate procedures to validate computerized systems used to capture and analyze data for clinical research

  • Works with Testing/QA team to fully understand product vision, scope, priorities, and requirements

  • Reviews completed test cases, test scripts and recorded results to verify that test results can be verified and that any defects are reported and corrected

  • Assists with creation of Validation/SDLC documentation for various systems, including, but not limited to:

  • Validation Plans

  • User Requirements

  • Test Plans

  • Test Cases

  • Test Scripts

  • Test Summary

  • Validation Summary

  • Assists with the review of Design/Development documentation to ensure any development documentation matches User Requirements and other related SDLC documentation

Ideally, you will have the following experience and education

  • Worked as a QA in the pharma industry

  • Worked on SW systems to support (e.g.) clinical trials EDC/CTMS systems, pharmacovigilance, drug adverse event reporting

  • Has worked with Pharmacovigilance PV products such as Oracle Argus

  • Experience with pharma terminology, GCP experience including User Requirements Spec (URS), Functional Requirements Spec (FRS), System Requirements Spec (SRS), Q/OQ/PQ tests

With cognitive computing, we are now able to see health data that was previously hidden, and do more than we ever thought possible. Discover what you can make of this moment. Embark on the journey with us at IBM Watson Health. watsonHlthCSUITSpecialist

  • At least 5 years direct related experience in a healthcare device or Life sciences pharmaceutical regulated process mature environment

  • At least 2 years direct related experience in a software development company