Sr. Manufacturing Supervisor/Sterile Supply Quality Assurance
Merck & Co
Initialize special operation team to review back log of sterilization records for product release of billion dollar global brands; Gardasil; Set goal, objectives, deadlines, schedule and approved staff component orders for customers; directly responsible for 16 direct reports on midnight shift operation; and 45 indirect reports in the department. 16 direct reports responsible for time approvals, disciplinary actions, merit compensation, evaluations, training, and overall integrity of components to global counterparts. Developed module for Global SAP(COMET 2.0) implementation; concentration supported Global PAS-X roll out and Standard Operating Procedure overhaul for BTM group for new MERCK brand recognition merger. Implemented standard Good Manufacturing Practice walk through with internal Compliance group which resulted in major reductions in APRs. Generated a high number in CAPAs to reduce the number of observation from external audits. This method resulted in a great inspection by 8 world health groups coming in within a 11 month span. Trained new associates for department that moved from a3x5 operation to a3x7 operation to support global manufacturing Organized and held weekly team meetings for associate to go over safety principles, metrics numbers, discuss performance on the floor, address changes in protocol, and impact to production.