Qa Spec. (Process Audit & Batch Record Review)

Perform one or more of the following duties and responsibilities in support of Company'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 records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
*Other duties may be assigned*
Requisitos:
Education: Doctorate degree or Master degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience. Sciences or Engineering
Preferred Qualifications:
Quality Professional with Manufacturing Process Audit and Batch Record Review experience. In addition, some knowledge or to be familiar with DAI process, PASx/MES application, MAXIMO, SAP and LIMS.
Available for non standard shift which includes nights and weekends.