| · Administer the CAPA process and Change Control process for GBO NA, Inc. · Provide support for CAPA for manufacturing process. · Organize and administer CAPA meetings. Drive CAPA progress together with Vice President of Operations and QRM. · Evaluate CAPA acceptance, root cause investigation and action items together with process owners and QRM. · Provide support for process owners to ensure corrections are timely and supply chain functions are aligned with investigation progress and results. · Participate in internal and intersite continuous improvement efforts by GBO project teams for CAPA and Change Control. · Ensure all deviations from established procedures are appropriately documented and investigated for root cause. Requires direct input on the creation and effectiveness of corrective and preventive action plans. · Assist with implementation and supporting on- going continuous improvements. · Identify, develop and implement process robustness improvements through lean principals. · Support site change controls as needed. · Responsible for maintaining quality standards to meet FDA requirements, CFRs, and internal company policies with respect to the CAPA and Change Control processes. · Responsible for investigating complex deviations and supporting the applicable CAPAs discovered in the upstream, downstream, manufacturing. · Ensure our programs and manufacturing are in a state of control and processes feeding into the CAPA System are monitored. · Maintain current procedures and execute quality functions within the Change Control/CAPA processes. · Review change control information for accuracy and conformance to established guidelines and procedures. · Other duties as assigned. | 
