Yaritza Mateo

Subject Matter Expert (SME) on Dispensing and Thawing processes (upstream). Lean Six Sigma project lead for cross-functional teams to ensure quality and delivery of products are consistently met for commercial facility. Support regulatory inspections as SME. Proficient in quality systems used for process lifecycle management for SOP’s, Change Controls, CAPA, Deviations, Protocols generations / executions and EBR. Ensures Risk Management activities are effectively completed to prevent potential failures to process, and systems based on severity and detection controls.

Subject Matter Expert (SME) on Aseptic Processing Vial and Syringe Filling (downstream) manufacturing using Isolators Technology. Support regulatory inspections as SME. Proficient in quality systems used for process lifecycle management for SOP’s, Change Controls, CAPA, Deviations and EBR. Ensures Risk Management activities are effectively completed to prevent potential failures to process, and systems based on severity and detection controls. Acting supervisor of the Syringe and Vial Filling Lines during the AML14 equipment qualification plan and Media Fills execution. Provided direct hands-on leadership and management of the vial line media fills (45,000 units during a 1-month period). Interact with suppliers for solutions to issues related to materials supply or upgrades to materials used for the fill and finish of drug products.

SME of the Syringe Filling process. Line leader of the Syringe Filling group. Assure that the required materials, supplies, equipment calibrations, facilities, utilities and documents are complete and available before starting the Filling Process. Provide trainings and Certifications to new personnel as well as to other team members. Active participation on the “Robot Introduction Syringe Filling Line Room 477” Project