Latoya Hunt Email and Phone Number

• Assists with visual inspection training and certifications/re-certifications for the Drug Product site for liquid and lyophilized products • Performs AQL’s and maintain visual inspection certifications• Subject Matter Expert (SME) for Component Prep and Compounding Areas• Assists with validation protocols and revising work instructions for Process Improvement• Serves as primary contact for Oracle transactions for all departments in the Drug Product site• Performs Batch Record Review for clinical and commercial Products in the Drug Product site to ensure all parameters are met during execution and all deviations are escalated and corrected. Write event notifications for found deviations as needed.• Provides process ownership through timely actions, related to equipment supplies, process concerns, safety concerns, and area for improvements

• Performed aseptic assistance within a vaccine environment to maintain sterility, required temperatures and pressure status.• Maintained inventory of departmental components to support process continuation activities.• Utilization of portable and stationary Particle Monitoring Systems to sample particulate air.• Performed wetted path cycles such as Cleaning-In-Place(CIP) and Steam-In-Place(SIP)to maintain sterility within a product transfer line• Performed Filter Integrity testing to ensure sterility of components• Utilization of filler machine to set up for vial filling activities• Proficient at Approval of Cycle documentation such as Rt Reports• SAP SME within the department training department personnel on SAP transactions and T-code usage• Performed Environmental Monitoring testing to support Quality activities.

• Requested and updated all SOP’s used in production area while maintaining new effective dates and revisions.• Collected sterility samples for microbiology in timely manner.• Completed product accountability for each batch and lot.• Reviewed production start-up and in-process batch records.• Entered production data into BPCS (Business Planning Control System) manufacturing execution system.• Update and Maintained Metric Boards

• Operated filling equipment in a sterile aseptic environment • Handled product within all applicable SOP’s cGMPs etc.• Operated equipment within the validated parameters.• Followed and maintained documentation records, accountability of solution and units throughout the production process.• Performed 100% final inspection on units. Operated packaging equipment to package production within all applicable SOP’s.