Brandon Donner, MSEM, SSGB, PMP

Design, develop, document, and implement a microbiology laboratory program in accordance with ISO 17025 for Microbiological test methods and Reusable Device reprocessing validation test methods Oversee and manage daily laboratory operations and test flow Oversee inventory stock and ordering Assist in development of laboratory LIMS system Assist in Microbiological laboratory ISO 17025 needs across the SmithNephew network Conduct and ensure completion of laboratory instrumentation calibrations Work with third party vendors on preventive maintenance activities of lab equipment Assist in medical device sterilization activities. Participate in Nonconformance and corrective and preventive action (NC/CAPA) program. Align Microbiology Laboratory with facilities, production and Health and Safety departments. Documentation Review and Sign-off Proper storage and protection of microbiology, sterilization and cleaning validation test and lab documentation. Ensure Good Documentation Practices Oversee microbiology laboratory Environmental Monitoring Program. Complete risk assessments. Complete testing method validations. Track laboratory data and trends. Support continuous improvement of lab processes and record management for optimal lab performance and compliance and access to data and documentation for reduction of cost and improvement of customer outcomes Participate as SME for lab audit Provide training for personnel on proper and safe use of laboratory equipment. Serve as back-up for microbiology and cleaning validation testing/projects Assist as needed in the preparation of lab solutions, reagents, and media and/or other laboratory apparatus Assist with IQ/OQ/PQ of lab equipment Maintaining good laboratory practices of cleanliness and order of Memphis lab Conduct laboratory audits for compliance with ISO 17025 and cGMP practices Lead Microbiology, Reprocessing, and cleaning teams "check in" meetings for scheduling or concerns related to testing or instrumentation

Restrict final product in SAP, Record deviations, verify and change HAACP skip lot, edit tests and results per specifications Verify update and validate site EMP program, lead QIR investigations, take investigative swabs around plant for root cause Train analysts and retrain analysts if nonconformities found. Participate in Kaizen activities root cause failure analysis CAPAs, documentation control and sign off, Validate lab equipment, order inventory, record POs and create service requisitions Trigger tests per deviations, maintain lab equipment, put in maintenance requests when needed Verify tests and results, run reports for missing analysis, communicate with production leads and supervisors based on results Lead weekly microlab meetings, update lab metrics for corporate and site food safety, manage daily lab activities Ensure lab and plant are within SQF and FDA guidelines, send out hazardous samples for positive confirmations,

Verify overall sterility of production processes using microbiological testing methods Test final product for various biological impurities associated with manufacturing environment regulations Coordinate with production on out of specification product, retests triggers and skip-lot modification Member of various continuous improvement projects and teams including safety team and implementation task force Implement TRACC best practices to improve production culture Active participation in CAPA action items and kaizen initiatives Collect and analyze data according to results, export and verify data, run reports for missing or out of spec, ensure microbiological quality goals are met Swab areas of plant for general cleanliness and contaminants Abide by FSMA, SQF, AOAC, and FDA guidelines and validated testing methods Develop/Correct SOPs and WIs for production and lab operations

Guarantee and ensure product quality and integrity by performing various analytical methods and instrumentation, analyze raw materials, in-process samples, and final product for accuracy and production documentation. Handle and resolve quality issues using research and testing, follow procedural discipline and company privacy, manage data using company LIMS, responsible for specification and release of product. Ensure safe working environment, follow SQF and GMP guidelines, ensure FDA regulations are met, coordinate with production