 Successfully led 5 QMS transition projects (Agile, TrackWise, SampleManager, E1, SuccessFactors) after Thermo Fisher acquired the Detroit site (previously owned by Becton Dickinson). Led project to reformat and update Detroit documents to align with Thermo Fisher requirements and systems. Transitioned project into routine document review process, creating new instructions and forms. Led project to align the change management process across multiple sites, including creating new electronic form.• Coordinate audit prep, host audits, and lead audit finding responses (internal, customer, and ISO certification)• Lead root cause investigations and drive CAPAs to effective closure• Manage planned and unplanned deviations, including product impact assessments• Perform trend analysis and track metrics, coordinate management review, track action items• Administrate document control for site, including technical reviews and processing change orders in Agile eDMS• Administrate training system for site, including creation and maintenance of training items in SuccessFactors• Review batch records for good documentation practices, process parameters, test acceptance criteria, etc.• Raw Material and Product release, CofA generation, customer inquiries, questionnaires, and other requests• Schedule and coordinate production area inspections, and follow up on resulting tasks• Stability (shelf life) program coordination, including assessments for product/process changes

Site purchased by ThermoFisher Scientific in 2018Design of MS Access databases and Excel spreadsheets for quality system coordination and project management.Use enterprise systems (SAP) to develop quality system and technical documents, perform quality system and technical document reviews and/or release product. Perform technical writing as needed.Review of batch records for GMP errors. Development and maintenance of product stability testing program. Investigation and coordination of quality events, including deviations, notifications, CAPAs, and change controls.

Phase III clinical trial readiness and cell culture productionProduction process optimizationClean room operationsSOP, batch record, protocol, report and regulatory submission writing, reviewing and editingGMP and ISO standardsPersonnel trainingEnvironmental monitoringFacility cleaning program developmentGowning program developmentWaste handling program developmentMaterials handling program developmentMaterial specification design and writingInventory management

Robotic workstation operationManual pipetting of compounds onto plates for assaysCompound managementLab clean upSupply stocking

Cell culture monitoring, trending, and adjustmentBioreactor operationClean Room operationsWarm Room operationsCold Room operationsDrawing Water-for-InjectionEquipment operation and maintenance