The position partners with QMS record owners across Manufacturing, Quality Control, Analytical Development, Supply Chain, Facilities and Engineering, and external partners to ensure that deviations, nonconformances, OOS/OOT and atypical results, CAPAs, and associated change control records are investigated thoroughly, documented accurately, and closed on time. Collaborate cross functionally with site personnel to provide guidance and drive resolution of end-to-end manufacturing and quality issues, working independently while partnering effectively with Manufacturing, Quality Control, Analytical Development, Supply Chain, Project Management, and external partners.