Specialist Qa

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:
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience

Natural Science-related background (e.g. Chemistry, Biology, Microbiology, etc.)

• Quality Assurance (QA), Quality Control (QC), or Incoming. Preferably in QA
• Deviations, Data integrity, Validation, Work Orders (WO), Equipment Alarms, Compliance, Investigations, Technical Support, or Regulatory reviewing and approving records.

Highly Desirable:
• Experience with managing records in Trackwise, review and approval of validation records and documentation
• Experience in Change Control and managing Deviations