 Provide Flexibility and Opportunities for improvement to the packaging lines Manage Documents and Systems as required. Responsible for packaging lines operational improvements Eliminate bottle necks and provide overall support to the Packaging Operations Assured compliance with GMP as well as compliance with all federal, state, and local government regulations. Assured a safe working environment for manufacturing personnel and maintains all equipment and facilities in order to meet manufacturing requirements Developed plan, line schedules to deliver results Assured that production lines, efficiency, OEE, training was met. Participated in the communication meetings and reviews required to assure results were met. Managed and led a technical area responsible to improve line efficiencies, OEE, reduce changeover and Maintenance times, and execute daily communication systems to track result, analyze reason for gaps and design a corrective plan to close those gaps

 Audited documents related to Quality Control/Quality Assurance, Manufacturing and Microbiology Laboratory to identify opportunities for a remediation response to the Regulatory Authorities. Enhance the client manufacturing batch record by redesigning the documentation, eliminated the redundant and unnecessary sections and reduced the Operators documentation errors. Improved accuracy and consistency of batch record documentation. Improved and identified opportunities to streamlined integrated manufacturing and QA documentation system increasing client compliance and reduce product disposition cycle and lead times.

 Manage overall accountability to lead the production/distribution operations and facilities of an assigned plant, in an integrated lean six sigma culture. Ensuring the pillars associated with TPM are progressing and being executed effectively. Responsibilities include the leadership and involvement in daily operations,  Developed and managed quality projects related to an FDA (Consent Decree) for major Life Science Companies. These projects included the re-engineering of the quality systems, designs and implementation of SOPs, Batch Records and Medical Device History Records, Line Clearance Solutions, Working Instructions and Quality Audit Process. Created solutions that explained both simple and complicated processes. These solutions have increased productivity, standardized work and minimized waste. Deliver professional solutions in compliance with the requirements of the FDA, ISO and GMP.