Specialist Qa (Aseptic Technique)- 33216

Functions: - Review and approve product MPs. - Approve process validation protocols and reports for manufacturing processes. - Request Quality on incident triage team.- Approve Environmental Characterization reports.- Release of sanitary utility systems.- Approve planned incidents.- Represent QA on NPI team.- Lead investigations.- Lead site audits.- Own site quality program procedures.- Designee for QA manager on local CCRB.- Review Risk Assessments.- Support Automation activities.- Support facilities and environmental programs.- Review and approve Work Orders.- Review and approve EMS/BMS alarms.- Approve NC investigations and CAPA records.- Approve change controls.- Provide lot disposition and authorize lots for shipment.Requisitos:Education: Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience.Science or Engineering.Preferred Qualifications:Aseptic Techniques, Change Control and New Product Introduction.