Specialist QA

SUMMARY

Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance 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 reco...

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