Supports Stage 3: Continued Process Verification as a part of new industry standards for the validation lifecycle, ensuring achievement of a data driven, continuous improvement process for maintaining product quality. Works with sterile injection products, encapsulated products and tableted products.

Provided services to various clients, projects, and ongoing service accounts, including:o Commissioning, Qualification, Calibration, and Validation testing on manufacturing process equipment and instruments.o Authored protocols and initiated controlled documentation in support of CQV projects.o Provided project planning, management, execution, and follow up.o Reviewed equipment specifications, manuals, and developed an understanding of how an instrument works; tested equipment to accurately verify it was working as intended. o Investigated failures and deviations, created reports.o Spare parts review, fit for purpose, and analysis. o Reviewed design specs to establish fit-for-purpose for systems.o Reviewed engineering drawings for accuracy.o Performed system walk-downs, and change control of processes.o Initiated and resolved client Corrective and Preventive Actions (CAPAs).o Investigated deviations and failures.o Provided summary and analyses reportso Created and maintained job plans, maintenance and PMs

Capital project management in organizing project design with on-site construction mangers.Reviewed P&IDs/AF&IDs, forwarded changes to management as needed.Managed outside vendors, established communication between client and CM.Created hazard analyses for lyophilizers, vial fillers, syringe fillers and autoclaves.Created initial draft design documents with end users for construction fabrication of new lab spaces.

Assisted development of medical simulation tool videos for cricothyrotomy Created simulation and tutorial videos o Building of simulation tool o Proper execution of procedure on the tool by the practitioner o Various modifications on tool to improve realism of scenario

Created and edited web based sales on eCommerce channelso Amazon o Searso eBay Improved listing quality to boost sales to $22,000/monthCreated web store templates for use throughout all sales sites. Various in house jobs:o Ensured warehouse inventory of several thousand products stayed stocked, o Provided customer service over phone and in person o Created an easy to use platform for internet sales throughout the businesso Pre-fabricated merchandise for delivery and installation