-Manage Life Cycle documentation projects, adhering to GMP principles and utilizing controlled change management software (KNEAT/eVal, MEDS, Veeva Vault)-Provide technical expertise and support mission-critical manufacturing teams for site MES software (PAS-X) 24/7-Execute User Acceptance Testing for MES batch record acceptance protocols-Author various GMP critical documents-Enhance batch record Design Review workshops

-Facilitate supplier quality efforts: APQP, process capability, audits, PPM analysis, PPAP submissions, SCARs -Support (P)FMEA efforts in conjunction with Manufacturing Engineering and Operations, create and maintain area control plans, manage audit schedules for Quality Technicians-Create and maintain Corrective Action Request (CAR) SharePoint site-Manage and author ISO documentation (ISO 9001:2015 Site Coordinator), create and maintain ISO SharePoint site-Manage Quality Clinics utilizing various RCA tools, data analysis (paretos, pivot tables), project management-Supervise, direct, and coach Quality Technicians’ daily activities

-Coordinate all special and modification orders for Engineering-Research engineering specifications to appropriately facilitate and ensure BOM accuracy

-Produced extremely technical Installation & Operation Manuals-Facilitated collaboration between departments for the purpose of gaining useful insights for Marketing efforts