The Specialist QA will 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.
Master’s degree in Sciences/Engineering and 3 years of Quality experience or Bachelor’s degree in Sciences/Engineering and 5 years of Quality experience.
Ultimate Solutions Corp. is an equal opportunity employer.
- Quality Assurance experience (on-the-floor Quality experience)
- Batch record review
- Lean six sigma or application of other process improvement methodologies
- Demonstrated leadership skills
- Available to work: 1st shift 5am – 1:30pm, Sunday to Thursday or Tuesday to Saturday; or 2nd shift 1pm – 9:30pm, Sunday to Thursday or Tuesday to Saturday