The Analyst oversees execution and maintenance of processes that support existing Quality System applications and their associated processes. This role helps to support business partners with the utilization of the application.
Quality Assurance Engineer needed to develop, modify, apply and maintain quality evaluation and control systems and protocols for processing materials into partially finished or finished electronic & mechanical spaceflight assemblies.
Interact with product management, project management and test teams to develop a strong understanding of the project and testing objectives; design and create test conditions and scripts to address business and technical use cases.
The candidate is expected to learn the business and technical components of the applications to perform activities related to Agile test planning, creation of test cases/scripts, test execution, defect management and project closure activities. The candidate is expected to have proven ability to work on complex testing projects and drive results by working across all levels - from test executioners to Senior Project and Technical Project Managers.
Lead internal analytical and process deviations associated with data integrity breach and train/guide site team in the investigation, root cause analysis and CAPA associated with these deviations including CAPA effectiveness checks.
Collaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations/exceptional conditions related to method validations, technical transfers or reference standard/critical reagent qualifications.
Assist in the deployment of risk tools in member firms, including configuration of rotation regulations and validation of historical data; schedule and run phone meetings with firms and document meeting results.