Qa Specialist-Qualifications-Validations-

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 experience in Quality Assurance (QA), Quality Control (QC), Incoming, Deviations, Data integrity, Validation, Laboratory Equipment, Work Orders (WO), Compliance, Investigations, Change Control, Technical Support, or Regulatory reviewing and approving records. Experience with managing records in Trackwise and with the review of validation records and documentation. Support various Transfer/Incoming/Validation activities across various areas such as Incoming/QC/Process Development/Facilities. Must have experience in Qualification/Validation activities. Bachelor Degree in Natural Science. Fully Bilingual. Available to work any shift. Qualified candidates please send resume to: **********