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 and 3 years of Quality experience or Bachelor’s degree and 5 years of Qualtiy experience
Ultimate Solutions Corp is an Equal Opportunity Employer.
- Experience in Quality Systems (QA role as reviewer/approver) or Experience in execution (Manufacturing or PD role) of Deviations, Change Controls, Process/Cleaning Validation, Equipment/Utilities/Facilities Qualification, Annual Product Review, Periodic Review, Risk Assessment.
- Project Management Skills
- Strong Organizational Skills
- Initiate and lead cross functional teams
- Demonstrate ability to interact with regulatory agencies
- Advanced data trending and evaluation
- Ability to evaluate compliance issues