- Provide Business Partner interface between the business and IS. - Elicit and document user requirements and workflow. - Evaluate workflow and requirements for process improvement. - Lead Computer validation efforts and author/approve documents for GxP systems. - Provide project management for medium/small projects. - Participate and support a Business Analysis Community of Practice team for identifying and recommending tools for BA activities.

Assist with cross-functional teams on project deliverable and activities for control system validation projects using the GAMP. Develop, revise, and approve documentation supporting manufacturing and utilities for Legacy, Prospective Qualification - Plan/manage validation activities for the Site Validation Master Plan which included co-developing Risk Assessments and Risk Mitigation in line with ISPE (GMPs for the 21st century) to facilitate work in resource-constrained environment to achieve 100% against metrics.- Project management and technical supervision of vendors, contractors and employees during validation projects with new and existing control systems that allowed timely completion of assigned project.- Perform troubleshooting with corrective and preventive actions (CAPA) of computer systems follow-up.- Conduct on-going Control Systems Validation activities.- Primary site trainer of computer validation life cycle and 21 CFR Part 11 for the Rouses Point TO&PS.

§ Volunteered to assist with the development of several computer systems Corporate (Level IIs) policies.§ Team Leader reviewing Level I/IIs against existing procedures for comments, Gap Analysis, Remediation Planning, Remediation Activities, Design Confirmation and Design Verification proposed as a Best Practice. § Team Leader for new process development (supplier assessment, periodic review, and risk management) and process improvement of document flow and efficiency.§ Approved Legacy, Periodic, and Prospective Qualification and Validation documentation and SOPs against current corporate and industry practice effectively and efficiently to effect a promotion.§ Mentored all levels of personnel on-site and between sites/corporate regarding Computer Validation and 21 CFR Part 11 as site Subject Matter Expert.§ Managed budget, metrics, development plans and objectives and assisted with departmental restructuring.

Managed personnel, trained, and supervised GLP studies for the Reproductive Toxicology Laboratory and performed system administrative duties for the department data management systems.• Assisted with development of protocols, amendments, and reports for New Drug Applications and Investigative New Drugs for FDA submissions.• Assisted with and trained personnel for ongoing in-life animal research studies and techniques.• Mentored/supervised personnel to teach various in-life data parameters (e.g. oral dose, C-sections, Clinical Observations, etc.) and Postmortem Examinations (e.g. adult and fetal postmortem, skeletal exams, etc.)• Trained users and managed the Teratology Fertility and Reproductive Toxicology (TFR/Tox) Data Management System (including design and qualification of new data parameters for TFR/Tox).• Developed requirements for and responsible for validation activities for Terastat (data access from TFR/Tox Oracle database for statistical analysis) and Teramate (queries designed to access same data for final report inclusion) in a GLP environment.• Supervised and trained personnel to validate and maintain computer controlled instruments used to measure behavioral/learning parameters of laboratory animals.• Decommissioned the obsolete data management system in compliance with GLPs.