Lead day-to-day plant activities ensuring that instruments and systems under GMP scope are maintained in compliance with SOP’s and Regulatory guidelines with an annual budgetary responsibility. Own metrology software maintenance, environmental monitoring, and paper records in an oral dose pharmaceutical plant with accountability for initiating, documenting, and completing investigations, change control, deviations, and CAPA. Responsible for overseeing project and people management and respective goals by supporting, directing, coaching, and disciplining employees while cross-collaborating with 5 departments in project planning, to modify methods and policies.◼Managed and perform day-to-day functions of the Metrology Department and provide training and supervision to Facilities, Manufacturing, Validation and Analytical Sciences with over 15 Staff Members and three Metrologists◼Improved overall Quality Control Metrics by 36% by implementing new environmental data management system (Dickson One), which also resulted in process improvement by reduction in related deviations on 93% and related work orders in 100%◼Increased overall In-house calibrations by +110%◼Support Regulatory Submissions, Quality Agreements, and Technology Transfers activities, resulting in on-time completion rate of 95% (training completed by assigned due date) & Safety Compliance rate of 100% (no accidents)

Served as a QC Specialist for Metrology Department within a Technical role charged with developing and evaluating calibration systems that measured characteristics of objects. Identified magnitude of error sources contributing to uncertainty of results to determine reliability of measurement process in quantitative terms. Developed calibration methods, procedure, and techniques based on principles of measurement science, technical analysis of measurement problems, analyzing data, accuracy, and precision requirements. Directed engineering, quality, and personnel in design, manufacture, evaluation, and calibration of measurement standards, instruments, and test systems.◼Coordinated use of over 5 outside contractors performing QC Metrology functions and the approval of over 13 suppliers and vendors resulting in achieving an 87% downtime in calibration and a 93% improvement in efficiency in the 1st year◼Audited calibration and preventive maintenance date and approved release instruments for use resulting in 100% released on-time after 9-months◼Organized 250+ gauges calibration activities for mechanical, electrical, and linear equipment monthly and scheduled and coordinated calibrations for 6- departments

Technical QA Specialist tasked with ensuring that devices, instruments, and monitoring systems under cGMP scope were maintained in compliance with the plant SOP’s, systems, procedures, FDA requirements, cGMP, GLP, and ISO standards. Responsible for input to the variance systems and CAPA program; including identification, data generation, summarization, closure and effectiveness. Reviewed and approved product Certificates of Analysis and labeled measuring devices. Aided Operations and R&D departments with Technical Knowledge, collaborative and creative ideas.

Held various leadership roles increasing in scope and responsibility over the period of 8-years; Metrology Supervisor 2yr, Compliance Expert & Project Manager 1yr, Technical Services/Calibration Supervisor 2yr, Field Service Engineer & Instrumentation 2yr, and Field Service Engineer & Scales Specialist.◼Managed ISO 9001 & 17025 standards accreditation projects demonstrating ability to interpret instructions and specifications◼Increased overall laboratory performance over 30% and team members’ performance in over a 25%◼First year in supervisory role within the Service Department, achieved 100% efficiency goal and surpassed team performance goal with 96%◼Enhance inventory by establishing control & distribution guidelines resulting in an inventory reduction in over 50%◼Awarded 2004 Employee of the year for Advanced Instruments Sales & Service◼Won 2004/05 Most Service Calls completed for Balances & Scales Technician