CAROL P.

ANDERSON
Apex, NC 27539 919.335.3077 http://www.linkedin.com/in/carolpanderson cpa88106@gmail.com

SUMMARY Quality Management Consultant with extensive background in problem solving quality and compliance issues in the pharmaceutical and medical device industry. Demonstrated ability to develop and implement Quality Systems compliant with national and international standards. Adept at providing guidance, facilitating sessions and delivering quality improvement programs to ensure compliance. Trained in Six Sigma and Lean Sigma methodologies and implementing Quality Control requirements including test specifications, sampling plan, method validation and instrument qualification. Key strengths are organization, pragmatic problem solving, accuracy, attention to detail and guiding, influencing and educating project teams to achieve compliance goals. Skilled GAMP Project Management Methodology LMS Plateau & Docent Computer System Validation RELATED EXPERIENCE SOLIANCE SERVICES AT DSM DYNEEMA, Greenville, NC 2011 QA Consultant - Contractor Project management oversight for the development of the procedural QMS Library. Facilitated meetings with representatives from different areas to review and define entire business process and develop process maps. Successfully met ISO requirements positioning organization to apply for certification. Ensured compliance for the manufacture of a new medical device product by leading the development of a procedural library to support ISO 13485 requirements. Reviewed and approved the documentation and provided guidance in the start-up and development of the laboratory to support the Quality Control requirements including test specifications, sampling plan, method validation and instrument qualification. Structured IT procedures and developed proposal for the development of IT governance procedures for software applications designed to support the medical device manufacturing process following GAMP guidance. Created process maps to determine which procedures needed to be created and defined the content of the procedures. Facilitated walk-through of entire process including sub-processes ensuring findings were recorded and documented items were addressed. GLAXOSMITHKLINE (GSK), RTP, NC 2000 2010 Quality Consultant / Sr. Quality Analyst (2003 2010) Consulted on global IT projects that enhanced the clinical trials and pharmaceutical development processes after providing quality oversight, mentoring and training of teams that ensured software development and testing was accurate and performed in a compliant manner. Conducted internal audits of computer systems and facilitated meetings to discuss findings and tracked CAPA findings to completion. Participated in external audits including inspection readiness training and support and oversight for audit preparation. Core Team member assigned to 3 separate initiatives that created software quality process / procedure frameworks using Six Sigma methodology, then implemented and maintained these frameworks which provided standardization and compliance to regulations and company standards in software development lifecycle activities. Performed Internal System Audits Quality Management System Development Adherence to GxP Regulations & Guidelines

CAROL P. ANDERSON
GlaxoSmithKline (GSK) RTP (Continued)

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Created a supplier audit process which included a generic questionnaire that allowed virtual audits and saved travel costs. Created a communication and training strategy for quality and compliance across R&D IT which included development of a web portal that allowed staff easy access to policies and procedures and provided communication of updates and training events. Developed a 21 CFR Part 11 assessment process for legacy and newly acquired computer systems and the acquired data that allowed system owners to easily determine the scope of compliance and any gaps in coverage and provided a generic set of test cases to cover all requirements. Led the roll out of the risk-based approach to computer systems validation by leading diverse business and IT teams in the development of GxP risk assessments of computer systems that provided a pragmatic analysis of business processes and validation requirements and ensured that IT projects focused validation efforts on critical items. Principal / Senior Support Analyst (2000 2003) Supported systems for Drug Development process across R&D that enhanced the regulatory submission process including incident resolution, software testing and creation of validation documentation set. Managed implementation of Remedy Call Tracking system in PreClinical IT which allowed computer system incidents to be tracked and reported centrally and standardized procedures. Supervised Remedy Administrators which included selection of candidates, appraising performance and providing guidance and support. HOWARD SYSTEMS INTL AT GLAXOWELLCOME, RTP, NC LIMS Technical Consultant 1997 2000

KNOLL PHARMACEUTICALS, Shreveport, LA 1983 1997 Analytical Chemist, Analytical Control Led lab team that successfully validated the Sample Manager LIMS, automated results, captured and generated reports and allowing for queries across fully documented data. Developed, qualified and validated analytical methods for new products and line extensions that ensured accurate and complete results that met Pharmacopeia (USP) standards. Authored SOPs and trained staff on analytical methods and LIMS usage that ensured consistent and accurate samples and collection of data. EDUCATION B.S., Microbiology, Northwestern State University of Louisiana, Natchitoches, LA CERTIFICATIONS IT Service Management (ITIL) Foundation, Council for Service Mgmt Institute, May 2007 Medical Technologist American Society for Clinical Pathologists - MT (ASCP) TECHNICAL SKILLS Microsoft Office: Reporting: Document Management: Software IT Service Management and Testing: Programming: Web: Learning Management: Word 2007, Excel 2007, PowerPoint 2007, Outlook 2007, Visio 2003 Crystal Reports, Toad for Oracle, Brio, Business Objects Documentum Webtop, Documentum Workspace Remedy IT Service Management, Hewlett Packard Quality Center HTML, SQL, Visual Basic Sharepoint 2007, Plumtree Content Publisher Plateau Learning Management System (LMS), Docent LMS