Quality Events Specialist
Core
Lead investigations for manufacturing deviations, environmental excursions, and process issues in Windsor biologics operations to identify root causes and implement corrective actions.
Role type
Quality Events Specialist (Biologics Manufacturing)
Builds
CAPAs and continuous process improvement initiatives for biologics production
Domain
Biopharmaceuticals / Advanced Manufacturing
Deliverable
client delivery
Required skills
Root cause analysis (RCA), deviation investigation, CAPA development, trend analysis, change control support, audit participation, cleanroom investigation, regulatory compliance
Preferred skills
Technical writing, cross-functional team leadership, aseptic behavior knowledge, environmental monitoring, QMS systems (MasterControl, TrackWise, Veeva)
Technologies
MasterControl, TrackWise, Veeva
Responsibilities
Lead investigations using structured tools (RCA, 5-Why, fishbone), assess product and equipment impact, develop and document CAPAs, analyze trends, support change controls and documentation revisions, participate in audits, support cleanroom and contamination investigations
Seniority
Mid-level, hands-on IC