Senior Associate Manufacturing Deviation Owner Environmental and Contamination Control

Accountable for end-to-end management of deviation records, including investigation, documentation, and resolution, ensuring compliance with site procedures and regulatory expectations. Owns deviation records (scope may include Environmental and Contamination Control; can extend across manufacturing events). Defines investigation strategy, conducts shopfloor observations and RCA, leads CAPA development and effectiveness verification, and collaborates cross-functionally with QA, QC, Process Development, Facilities, and other teams. Serves as SME during inspections, defends rationale and classification decisions, and utilizes digital tools to streamline investigation processes while advancing deviation documentation updates and ensuring data integrity. Demonstrates technical writing ability to articulate complex events clearly and inspection-ready, with a focus on continuous improvement and contamination control opportunities.