DescripciónDescriptionReview 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.
Requisitos RequirementsMasters + 2 years of directly related experience.
Bachelors + 4 years of directly related experience.
Associates + 8 years of directly related experience.
High school/GED + 10 years of directly related experience.
Life Sciences or Engineering
Preferred Qualifications:
Experience performing Quality Oversight Supporting Supply Chain & Incoming operations experience.
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