Kathryn Lyons Email & Phone Number

• Implement error prevention, compliance improvement, and efficiency updates to systems, processes and SOPs
• Develop and manage company training program for new hire onboarding
• Generate and implement CAPA action plans in response to audit observations and customer complaints

Portsmouth, NH

• Management of Microbiology Laboratory and Environmental Monitoring departments (up to 45 staff)
• Provide operational oversight and technical leadership to maintain on-time delivery, manage productivity, reduce deviations, and uphold right-first-time execution
• Lead Microbiology representative for regulatory and customer audit inspections

Lexington, MA

• Management of Microbiology Laboratory In-Process and Drug Substance testing department (12 staff)
• Department representative on cross functional teams and committees in support of Manufacturing, Quality Assurance, Engineering, and Validation initiatives
• Disinfection Improvement Team Lead Member, tasked to implement a company-wide cleaning program for the Manufacturing cleanroom areas

Salem, NH

• Management of Microbiology Laboratory and Environmental Monitoring department
• Review and approve protocols, technical reports, assay data, release test results, trend report statistics and ensure compliance with technical standards and regulatory guidelines
• Coordinate department scheduling and assigning weekly tasks

North Billerica, MA

• Develop new & modified microbiological methods, evaluate new materials & products and establish testing standards
• Execute Validation projects for LIMS design, microbial identification instrumentation, endotoxin method qualification, sterility isolator implementation, and environmental monitoring equipment
• Perform extensive revisions and updates to cGMP procedures & relevant documentation

• Quality Management System process owner: Microbiological Deviations, Investigations, Change Controls, CAPA
• Execute and perform method validation for laboratory assays (Bioburden, Endotoxin, Sterility, Growth Promotion, Microbial Identification), including generation of summary qualification reports
• Perform Environmental Monitoring (total airborne particulate, airborne viable particulate, surface viable, settling plate, swab), including generation of Facility Trend Reports

Master Of Business Administration, Entrepreneurship/Entrepreneurial Studies

Bachelor'S Of Science, Biology

Activities and Societies: General Biology Laboratory Teaching Assistant, Multiple Dean's List Recipient