Tracy Clarke Email and Phone Number

Short term international assignment

Coordinated periodic reviews and support for corporate IT and laboratory computer system applications.Conducted system retirement for obsolete corporate computer systems using internally developed tools and strategies.Maintained templates and tools for validation and electronic and hard-copy file handling.Supervised and mentored fellow technical writers and validation specialists on cGMPs.Tracked and coordinated action items for validated laboratory and IT systems.Supported documentation and project needs for major GMP computer system upgrades.Developed process improvement standards and guidelines.Created testing protocols for laboratory equipment and computer systems upgrades.Developed application specific change management process around large scale computer systems.Applied risk-based approach to all validation efforts using corporate standards to ensure project quality and efficiency for new computer system implementation.

Quality Managed quality assurance for major GMP computer systems upgrade, remediation and new construction projects.Conducted quality reviews of all validation, commissioning, and qualification documentation, including user requirements, design specifications and testing for various GxP automated computer systems.Developed local and corporate procedures/standards to support quality and automation engineering processes.Coordinated with clients regularly to ensure quality standards are addressed in new project development.Performed audits at client sites to measure risk and assess gaps in regulatory compliance.Assisted project managers and sales representatives with project scope development and pricing.Maintained Quality Manual and conducted team training on quality standards and processes.Created and maintained template documents for validation, qualification and commissioning document deliverables.Implemented Performance Quality Evaluation program to ensure proper maintenance of validated HVAC systems.Maintained system acceptance database and tracked action item resolutions for validated systems.Provided training for team on Good Documentation Practices and Good Engineering Practices.

Developed Standard Operating Procedures, Guidelines and Work Instructions for Corporate Data Center Operations and Infrastructure Teams.Provided customer satisfaction reports and service level agreement reports through Remedy ARS system for service level review.Created qualification protocols for Enterprise Information Services.Assisted Disaster Recovery Team and participated in mock disasters to validate and ensure appropriate security levels were met.