_{17th February, 2026}

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.
• Bachelor Science (Biology, Chemistry, Physics, etc)
• Expericence in Quality and Compliance, experience with validation protocols and reports for clean utilities, manufacturing processes, cleaning processes, equipment, computerized systems, change control records, deviations,etc.
• Experience in biological processes desired.

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