Qa Specialist-Edm Quality-Project Management Skill

Descripción del Empleo:
Perform one or more of the following duties and responsibilities in support of Company’s Quality Assurance program under minimal supervision. 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:
Minimum 5 years of directly related experience. Experience in working in a complex network environment/Quality Management System Requirements. Previous experience managing documents in EDM Quality. Project Management Skills. Strong Negotiation and Communication Skills. Writing controlled documents. Knowledge of Regulatory Requirements for GMP documents. Bachelor Degree in Science or Engineering Completed. Fully bilingual. Must be available to work any shift. Qualified candidates please send resume to: **********.