Michael Ramirez Email & Phone Number

United States

Pleasanton, California

■ Competent in using ERP Systems (QAD): Release and close work orders, issue components to FG Builds upon completion, and transferring of materials into Clean Room. ■ Lead and participate in Quality Audit Teams to ensure procedures are followed accordingly ■ Direct production team to ensure goals and quotas are met ■ Worked closely with Engineers and Technicians to improve current processes ■ Assist Management team to create a 5W2H during a CAPA ■ Review Device History Records (DHR) upon completion of Work Order ■ Leaned manufacturing line to increase daily throughput

Pleasanton, California

Supported Manufacturing set-up, operation, troubleshooting and dismantling of equipment used for the preparation of drug delivery systems.Assisted with resolving technical issues as well as maintenance of production equipment. Followed all relevant standard operating procedures and complete master production records in a cGMP environment.Reviewed Batch/Lot material issuance for completeness and accuracy and performed Batch/Lot material reconciliation as required.Completed and Reviewed batch production records to ensure cGMP documentation practices are followed and information entered is complete and accurate.

Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, Good Manufacturing Practices, and FDA regulations.Maintain clean room integrity by using proper attire and adherence to clean room environment practices and procedures.Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, test fixtures, or other process equipment.Train Operation team on MPIs, WIs, and/or SOPsAssist in writing of Manufacturing Process Instructions (MPI) and Lot History Records (LHR).Work with engineers, quality assurance and technicians to resolve line issues and suggest improvements.Maintain accurate records/documentation related to quality, work in progress, test results, labor (e.g. timecards), and special projects.With the assistance of the production supervisor, establish production priorities.Coordinated Lean Flow Manufacturing within the Manufacturing Line