Specialist Qa

Descripción del Empleo:
Perform one or more of the following duties and responsibilities in support of Amgen’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:
Master’s degree in Sciences and 3 years of directly related experience or Bachelor’s degree in Sciences and 5 years of directly related experience.

•Ability to oversee multiple projects simultaneously
•Applies tactical appropriate to ensure QS are affective, efficient and agile including reducing backlog of quality records
•Develops innovative and creative output based on interpretation and analysis
• Integrates trends, data and information into plans, deliverables and recommendations across QS
•Manages key projects or business processes
•Able to successfully manage workload to timelines
•Familiarity with basic project management tools
•Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, and high-quality results