Quality Assurance Specialist
hace 4 semanas
Validation & Engineering Group, Inc. is seeking a talented Quality Assurance Specialist to join our team.
Job SummaryWe are looking for a Quality Assurance Specialist with experience in manufacturing process audit and batch record review. The ideal candidate will have knowledge of DAI process, PASx/MES application, MAXIMO, SAP, and LIMS.
Key Responsibilities- Review and approve product manufacturing processes
- 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
We are looking for a candidate with a Doctorate degree, or Master's degree and 3 years, or Bachelor's degree and 5 years of directly related experience.
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