Cary Thomas Email & Phone Number

• Responsibilities include:
• Coordinate FDA Readiness activities and training needs
• Facilitate FDA & DEA inspections, customer audits and third party certifications
• Prepare responses for audit observations and verify CAPA completion for observations
• Manage internal audit plans, perform system audits and routine Gemba walkthroughs
• Oversee supplier management and supplier qualifications activities

• Responsibilities included:
• Facilitated FDA inspections and customer audits and prepared CAPA responses
• Maintained audit plans and conducted internal and external compliance audits
• Tracked and verified CAPA completion for audit observations
• Assessed product quality issues and compliance concerns for senior management
• Reported audit activities and observation trends to senior management

New York, New York, US

• Responsibilities included:
• Facilitated FDA inspections and corporate audits and provided CAPA responses
• Maintained audit plans and conducted internal and external compliance audits
• Tracked and implemented CAPA for audit observations
• Assessed product quality issues and compliance concerns
• Reported audit activities and observation trends to senior management

New York, New York, US

• Responsibilities included:
• Supported audit team with FDA inspections and corporate audits
• Conducted internal and external GMP compliance audits
• Provided project teams guidance on compliance requirements and regulations
• Maintained and trained on Systems Development Life Cycle procedures
• Reviewed and managed computer validation deliverables

New York, New York, US

• Responsibilities included:
• Project management, computer systems support and validation activities
• Coordinated upgrade of an environmental monitoring system
• Developed and upgraded databases used to support business needs
• Administered the calibration management system

New York, New York, US

• Responsibilities included:
• Developed computer validation standards, policies and procedures
• Wrote Standard Operating Procedures for computer systems
• Developed Disaster Recovery plans for computer systems
• Implemented Service Level Agreements with IT groups for validated computer systems
• Developed and validated databases and reports supporting business needs

New York, New York, US

• Responsibilities included:
• Supported computer systems for approximately 200 clients
• Managed a computer hardware and software inventory
• Justified and implemented systems for use in a Research and Development facility