Specialist Qa - Process Characterization

Descripción del Empleo:
Perform one or more of the following duties and responsibilities in support of 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:
Bachelor’s in Sciences degree and 5 years of directly related experience
Preferred Educational Background in Engineering or Biotechnology with experience in Parenteral Mfg.
Preferred experience: Project Management; Process Characterization; Environmental Qualification, Process Development.
Non-standard Work. Need to be available to work on 1st, 2nd & 3rd