Karen Dechandt

Led quality approvals for the development and validation of a new manufacturing facility for BWXT Medical

• Expertise in developing and implementing comprehensive quality plans, process flows, test methods, verification protocols, reports, and procedures, significantly enhancing process efficiency and risk management.
• Achieved 100% approval for multiple assets and documents in asset management and quality management databases.
• Supported process validations life-cycle by investigating deviations, implementing corrective actions, and contributing to process improvement through change control management
• Led quality approval and training of updated procedures and other controlled records in the quality management database
• Cross-analyzed user and functional requirement specifications for software development and validation of automated radiopharmaceutical facilities

• Led process improvement initiatives, utilizing Six Sigma methodologies to enhance operational efficiency and product quality
• Conducted risk assessments, developed, and implemented risk mitigation controls, improving process reliability and safety
• Managed projects from conception through to completion, including facility qualifications and asset management
• Implemented and managed corrective actions (CAPAs), change controls, and supplier qualifications

• Verified and documented in-process controls to ensure food safety under Hazard Analysis and Critical Control Point (HACCP) regulations and BRC global standards
• Managed non-conformances, evaluated analytical methods and led training to processes improvement and quality standards, significantly reducing non-conformance rates
• Participated in internal audits and work in compliance with established safe work practices and procedures