SUMMARY:

• Transformational technical leader with more than 20 - years of experience performing validation and QC testing.
• Technically sophisticated Senior Validation Specialist with notable expertise developing and executing validation strategies and project plans for computerized systems and software.
• Highly skilled in integration/qualification and testing of equipment driven by computer system interfaces.
• Extensive knowledge and success in a computer system validation, with a keen ability to analyze existing systems, develop testing and validation plans, identify root causes for system failures, and create technical solutions to minimize production impact.
• Skilled trainer and project manager capable to directing multiple tasks effectively and master innovative software tools.

CORE COMPETENCIES:

• Project Management
• Systems Launch / Implementation
• Process Validation Protocols
• Client Relationship Management
• Computer System Validation Lifecycle
• Quality Assurance and Testing
• Software/Hardware Testing Methodologies
• Problem Resolution / Troubleshooting
• Validation Strategies
• SOPs, Validation Plans, Change Control

TECHNICAL PROFICIENCIES:

Platforms: Windows

Tools: GAMP, 21 CFR Part 11, GxP compliance, Data Integrity compliance

PROFESSIONAL EXPERIENCE:

Confidential, Framingham, MA

Manufacturing Systems Specialist

Responsibilities:

• Managed a project team for a data integrity remediation project.
• Generated supporting documentation to confirm systems met the regulatory requirements for data integrity, which included updating user requirements, functional requirement specifications, configuration specifications, and creating protocols to confirm systems met the regulatory requirements for data integrity.
• Operated as primary point of contact between the Business Owners and Information Systems to govern data integrity compliance.

Confidential, Willow Grove, PA

Sr. Validation Specialist

Responsibilities:

• Developed validation strategies to govern the entire validation process.
• Phases include gathering and analyzing user requirements, functional requirement specifications, creating validation plans, qualification protocols, and qualification protocol summary reports. Integrated a risk-based methodology consistent with Confidential and other industry best practices for operating and managing laboratory instruments and equipment. Implemented a critical monitoring system, a computerized maintenance and calibration management system, and a laboratory information management system to automate processes and eliminate a laborious validation procedure.
• Generated supporting documentation to confirm systems met the regulatory requirements for data integrity.
• Designed data acquisition and analysis software templates, and MS Excel spreadsheets to streamline reporting and data distribution.
• Implemented an enterprise resource planning system, and a distributed numerical control/program change management system to centralize operational tasks and consolidate system functionality.
• Created and implemented Standard Operating Procedures and work instructions for administration of various computerized systems, and their associated validation processes.
• Operated as primary point of contact between the Business Owners and Information Systems to govern software validation and computer system compliance.

Sr. IT PMO Technical Writer/Project Coordinator

Confidential

Responsibilities:

• Developed and implemented work instructions, configuration specifications and qualifications checklists for barcode scanners.
• Consulted with project stakeholders to provide status updates, discuss change management processes, and discuss possible delays according to approved changes.
• Managed User Acceptance Testing, and oversaw testing schedules for barcode scanners.
• Delivered training presentations to personnel for the qualification and usage of barcode scanners.
• Facilitated system testing for an automated data collection system, documented test results, and forwarded to associated business units for further review.
• Operated as liaison between IT and system owners, ensure ongoing communication regarding projects, delays, and criteria for final deliverables.

Confidential, Phoenix, AZ

Computer System Validation Specialist

Responsibilities:

• Drafted validation documentation including user requirements specifications, validation plans, system requirements specifications, summaries, Standard Operating Procedures (SOPs), and qualification protocols in support of laboratory remediation for a Consent Decree.
• Generated supporting documentation to confirm systems met the regulatory requirements for data integrity.
• Facilitated the development and implementation of Validation/Qualification protocols.
• Mentored three Computer System Validation Specialists on computer system validation strategies.
• Coordinated the execution of comprehensive qualification testing programs in compliance with company, customer, and industry requirements.

Confidential, McLean, VA

Validation Test Specialist

Responsibilities:

• Gathered and analyzed system requirements and assessed project feasibility based on requested timeline, budgets, and staff availability.
• Designed and implemented testing strategies and associated documentation for a Laboratory Information Management System project.
• Created UAT plans, performance test plans, and master plans, and allocated the necessary resources to set and maintain a stringent testing schedule.
• Oversaw operations for the test team including task assignments, coordinating activities with cross-functional project teams, ensuring compliance with project timelines and quality standards.
• Developed and executed test plans; generated, presented, and documented results, and forwarded to associated business units for further review.

Confidential, Fairport, NY

Validation Specialist

Responsibilities:

• Constructed Qualification protocols and summaries to integrate a risk-based approach for computer interfaced analytical equipment (e.g., bio-analyzer systems, surface Plasmon resonance-based analytical systems, and real-time PCR systems).
• Generated supporting documentation to confirm systems met the regulatory requirements for data integrity. Facilitated communications between Quality Systems and IT teams to coordinate Software Validation and ensure IT Compliance.
• Operated as team lead for a project validate computer interfaced analytical equipment, enterprise software systems, and laboratory information systems.
• Operated as primary point of contact between the business and IT to govern software validation and computer system compliance.
• Developed new workflow process to help establish efficiency, accuracy, and enhance productivity for the client.
• Diagnosed and supported root cause analysis of testing failures by gathering and interpreting data.