Specialist Qa - 33484

Requirements:
Quality Professional with Manufacturing Process Audit and Batch Record Review experience. In addition, some knowledge or to be familiar with DAI process, PASx/MES application, MAXIMO, SAP and LIMS. Available for non-standard shift which includes nights and weekends. Project management skills. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Education:
Doctorate degree or master's degree and 3 years of directly related experience or bachelor's degree and 5 years of directly related experience.
Job Functions:
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.
This is a professional services contract and a non-standard shift.
Job Types: Full-time, Contract
Schedule:
8 hour shift
Work Location: In person