Production Operator I

Job description

Overview Operator I supports cGMP pharmaceutical manufacturing activities by executing batch operations, cleaning and setup, in-process checks, and documentation with a strong focus on safety, quality, and right-first-time performance. This role is fully trained to operate designated equipment and to work effectively within a cross-functional team in a regulated environment. Responsibilities: Documentation & Quality • Complete batch records, logbooks, and forms accurately and legibly; reconcile materials and yields.• Initiate notifications for deviations, OOS/OOT, or atypical events; support investigations and CAPAs as needed.• Participate in audits, room/equipment release, and lot sampling activities.• Meet or exceed KPIs (Right-First-Time, schedule adherence, yield, 5S audit scores etc.).• Suggest and help implement process and documentation improvements (lean, 5S, SMED).• Collaborate with QA, QC, MSAT/Process Engineering, Supply Chain, Facilities, and EHS. - Perform manufacturing steps per approved batch records (e.g., dispensing, measuring, charging, mixing, filtration, filling, capping, packaging etc.) and record results contemporaneously.• Set up, operate, and monitor assigne...