_{15th September, 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  in Sciences or Engineering + 4 years of directly related experience OR -Associates + 8 years of directly related experience OR -High school/GED + 10 years of directly related experience.
• Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ, PQ, Functional Test).
• Technical Writing
• Quality Systems (Deviations, Change Control) and Maintenance (PM, Work Orders, Job Plans review and approval) knowledge.
• Technical Documents review (Validation Reports, Procedures, Forms).

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