Renee U.

Manager Site Quality Systems @Quva

Sugar Land, TX, US

Manage, develop and lead 2-5 Quality System Specialists• Manage the internal audit and inspection readiness programs for site including coordination of regulatory (FDA) audits, and customer audits• Responsible for all activities related to the Batch Record Issuance/ Quality Document Administration/CAPA/Deviation/Investigation/Change Management Systems• Manage investigation/deviation activities by working with other departments to determine the possible causes of the deviation. Aid in the analysis of each of the possible causes in order to determine the true root cause. Coordinate follow up on due dates and status reports and closure• Provide review of investigation reports and supportive documentation (including data) for accuracy and completeness, where needed• Maintain the CAPA System and Change Management System, following up on due dates and status reports and closure with appropriate documentation• Proposes and executes process and procedural changes to improve QS process performance, robustness, and efficiency • Establishes standard and meaningful metrics that align to goals, mission, and objectives for applicable department/program. Develops and distributes metrics to support the business• Facilitates site Quality Review and Management Review Board meetings• Collaborates functionally and cross-functionally to meet Quality Systems objectives and initiatives• Interacts with site efforts to ensure consistency in policies and practices

University of California, Los Angeles

Bachelor's Degree

University of California, Merced

Transferred to UCLA to finish degree