Specialist QA 35271

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.

• →Review and approve product Master Plans (MPs).
• →Approve process validation protocols and reports for manufacturing processes.
• →Participate in Quality on Incident Triage Team.
• →Approve Environmental Characterization reports.
• →Release sanitary utility systems.
• →Approve planned incidents.
• →Represent QA in the New Product Introduction (NPI) team.
• →Lead investigations and site audits.
• →Own and maintain site quality program procedures.
• →Serve as QA Manager designee on local Change Control Review Board (CCRB).
• →Review and assess risk evaluations.
• →Support automation activities, facilities, and environmental programs.
• →Review and approve Work Orders and EMS/BMS alarms.
• →Approve non-conformance (NC) investigations and CAPA records.
• →Approve change controls

• Quality Professional with experience in Equipment, Automation and Validation.
• Knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, and LIMS.
• Experience in Change Control.

• Doctorate or Masters + 2 years of experience, Bachelors + 4 years of experience, Associates + 8 years of experience or High school/GED + 10 years of experience.
• Sciences or Engineering