_{13th October, 2025}

SUMMARY
Perform one or more of the following duties and responsibilities in support of  program under minimal supervision.

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.
 
REQUIREMENTS
 

• Doctorate OR Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience OR Associates + 8 years of directly related experience OR High school/GED + 10 years of directly related experience
• Supply Chain
• Incoming sampling and inspection
• Quality audit of warehouse floor operations
• Proficient in Smartsheet, Generative AI, Power BI, SAP
• Initiating and approving Quality deviations (nonconformances)

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