George Hollen, Mba Email & Phone Number

Wilmington, North Carolina, United States

• Independently lead multiple IRT/RTSM projects of high complexity.
• Act as primary point of contact for clients, keeping them apprised of all project developments while maintaining stellar client satisfaction.
• Build effective partnerships with other internal teams to move project through all phases of the development process.
• Develop and maintain project schedule, identify and track milestones and identify and manage cross-functional dependencies and risks.
• Act as subject matter expert on client clinical study protocol
• Manage ongoing reporting of project health and profitability to internal and external stakeholders.

Wilmington, North Carolina

• Perform review/approval of test cases for mid-level and other Senior Quality Analysts.
• Define scope of validation efforts for change controls
• Provide guidance on testing and departmental objectives.
• Perform IRT / Interface validation & UAT documentation including writing and executing test scripts based on system design specifications and protocols.
• Review and validate Supplies Distribution Management (SDM) configuration of depots, material groups, types, and statuses, initial and re-supply ordering plans, and inventory alerts
• Provide review of system design specifications prior to build to ensure validity.

Wilmington, North Carolina Area

• Perform IRT / Interface validation documentation including writing and executing test scripts based on system design specifications.
• Provide review of system design specifications prior to build to ensure validity.
• Perform document management functions including but not limited to: document review, organization and archiving
• Perform routine auditing functions ensuring that the IRT department is operating in compliance with PPD approved procedures as well as current FDA regulations (21 CFR Part 11).

• Ensured computer validation activities and use of electronic records are in compliance with internal procedures, policies, and international guidelines and regulations.
• Performed detailed internal audits and reviews of computer system validation and change control documentation to confirm consistency, accuracy, and compliance to PPD-approved procedures.
• Participated on vendor software assessments and contract service providers.
• Served as an audit host for external clients.
• Consulted and mentored computer validation coordinators and teams in the proper creation and execution of validation plans and testing scenarios.
• Trained employees on FDA requirements for electronic records and signatures.

Supervised and led a GMP pharmaceutical manufacturing team by directing daily manufacturing activities, training and developing employees to deliver quality products, reviewing production records, validation protocols and administering standard operating procedures. Experienced and trained in Root Cause Failure Analysis (RCFA). Used exceptional.

Part of a team of engineers responsible for the commissioning and validation of new equipment, facility, packaging and critical utilities (HVAC, Electrical, Compressed Air, USP Water). Experience with Johnson Controls Metasys Building Management Systems. As a Certified Trainer I was responsible for training staff on new SOP's and Training Modules in.

Created and executed IQ/OQ/PQ validation protocols with respect to: Packaging Equipment, Manufacturing Equipment, PLC validation, HVAC, Laboratory Equipment, Sterilizers, Autoclaves, Heating Ovens, Environmental Chambers, Critical Utilities and Facilities. Demonstrated ability to use regulatory knowledge to resolve quality and compliance issues with.

Responsible for assisting engineers with carrying out multiple experiments and projects. Responsible for making sure orders were shipped to external clients on time and that all measurement data was correct and accurate. Demonstrated ability to maintain a constructive problem-solving attitude while dealing with time demands, incomplete information or.

Masters, Business Administration

Activities and Societies: MBA Association Class President Norman Kaylor Most Outstanding MBA Student Award Recipient

Bachelor Of Science (Bs), Industrial Technology

Diploma