Ncr -Batch Rec.Review -Capa-Qa Specialist

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. Other functions may be assigned.
Requisitos:
Minimum 5 years of experience within the Manufacturing Environment. Direct experience in Quality Assurance related to the Manufacturing Process that included but not limited to Batch Record review, Non-conformance, Validation documentation, Facilities audit, general regulatory inspections. ASQ Certifications (CQE, CQA, etc.) or similar. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills. Bachelor Degree in Science or Engineering Completed. Bilingual. Qualified candidates please send resume to: **********