Sr. Systems Analyst, QA IT Compliance

Posted on: 2006-08-19

Resume of Theresa Wright 5492 West H. Avenue, Kalamazoo, MI 49009 Work: 269-833-1756, Home: 269-382-3278 Email: [email protected] Summary: Sr. Systems Analyst with 15 years of experience in all aspects of computer system management and system life cycle development (SDLC). Strong business analysis, software engineering, project leadership and technical skills. Over 11 years experience in Quality Assurance (QA) and Compliance with a strong working knowledge of Good Manufacturing Practices (GMP), FDA and Regulatory Pharmaceutical Requirements to ensure system Regulatory Inspection Readiness. Professional IT Experience:  SDLC development methodologies, Business Analysis and Conceptual Design, Data and Process Modeling, Prototyping, Impact Analysis, Requirements definition, System documentation and facilitating business application fit.  System Test Strategy and Execution - Unit, Integration, Performance/Stress, Tuning, Exception Processing and Failure scenarios, Installation, Operational, Production and User Acceptance.  Comprehensive Business System support and solution oriented troubleshooting.  Programming skills to debug and review Source Code, Pseudocode, Algorithms, Logic Constructs and SQL query structure for relational database applications and customized reports.  Custom development of automated data acquisition systems and data transfer interfaces for laboratory instruments. (Chromatography, Balance, ISE, UV-VIS, Auto-Analyzer, GC, GC/MS.)  Project Leadership to support Global, Corporate and Site initiatives; including Planning, Estimating, Cost/Benefit Analysis, Quality Management and Metrics, Reporting, Risk Assessment and Change Management.  Dimensions of experience include roles as End-User, System Owner, Quality Authority, Leadership, Supervision, Development and Support in an IT environment. Professional QA Experience:  Computer Compliance Team – developed and implemented corporate compliance standards, policies, procedures, templates to drive system alignment to meet new regulatory requirements.  Compliance Program Administration for Corporate Shared Computer Systems – Governance of GMP and 21 CFR Part 11 System Assessments, remediation strategies and harmonization, implementation and enforcement of compliance plans.  Over 6 years of Quality Assurance Review of corporate computer system validation documentation against Quality and Compliance Standards.  Extensive skills in the interpretation and application of cGMP requirements in a Pharmaceutical FDA-regulated manufacturing environment and an Environmental / EPA regulated environment. Professional Skills:  Teamwork skills - exceptional ability to partner, collaborate, negotiate, drive consensus and set expectations by offering creative and innovative ideas and solutions.  Proven track record of delivering high quality, innovative solutions on-time for small and large-scale global projects. (Directed team that developed, delivered and validated 70 custom LIMS system modules in a 6 month period.)  Unique intuitive talent to conceptualize and understand the broad perspective as well as the key details simultaneously to formulate potent impact analysis and drive innovative solutions.  Excellent technical writing, communication, organization, multitasking and prioritization skills. Technical Qualifications:  SQL*LIMS System - 20 years experience in usage, development, technical validation and support for system modules and interfaces. Completed SQL*LIMS training courses.  Environments: Familiarity with PC, Client/Server, Metaframe, Server and Web based applications.  Microsoft Office, Microsoft Project, Visio, Front Page and Web portal development.  Databases and Tools: Oracle, Ingres, Microsoft Access, DB2.  Development/Modeling: Oracle Developer, SQL, Toad, Case Tools, Function Point Analysis.  Familiarity with HTML, C, Visual Basic. Education:  Master's Degree in Computer Science - Grand Valley State University (2001)  Master's Certificate in Information Systems Management - Grand Valley State University (2000)  Master's Certificate in Software Engineering - Grand Valley State University (1999)  Bachelor's Degree in Biology/Chemistry - Kalamazoo College (1979)  Graduate study Physics and Computer Science - Western Michigan University (1980-1985)  Clayton College of Natural Health Ph.D. program (2005-present)  Professional Development: GMP Lab Compliance courses Publications and Awards:  Authored Shared Computer Systems Validation and Change Control (SOP 16603)  Authored the Site Master Validation Plan for Corporate QA  Published "Segmented Flow Analysis" Methodology in Standard Methods, 20th ed.  Pioneered the Environmental Lab Analyst Certification program with Michigan Water and Environment Federation Laboratory Applications Group.  Joint Editorial Board for review and update of Standard Methods, editions 16 - 20.  Sigma Six Deviation Management team recognition (Mohamed Bawazeer, 2006)  Marketed Products Employee Recognition Award (Shelley Miller, 2001)  Departmental Employee Recognition for special service (Rick Whitfield, 1999) Employment Highlights: Pfizer Sr. Systems Analyst, IT Quality Operations (April 2005 - present)  Project leadership for 5-10 computer system projects, upgrades and changes per year  Management of SQL*LIMS and various Quality Operations Business Systems Applications (customer support, validation services, technical documentation and change control.) Application of most QA/QC Consultant functions. QA/QC Consultant IV, Sr. QA Professional - Several positions in Corporate Quality Assurance of increasing responsibility (1998 - 2005)  System Owner Designee responsibility for validation, lifecycle support, maintenance and development for SQL*LIMS and shared computer systems. Representation of computer systems during regulatory audits and inspection. System Inventory for Corporate QA shared systems.  Disaster Recovery and Business Continuity Planning and testing for Shared Systems.  Project leadership for computer system upgrades. Facilitated the centralization of computer systems and data from multiple sites.  Compliance Management Services for all Corporate QA systems.  Quality Assurance Review and Approvals for computer system validation documentation. City of Kalamazoo Water Reclamation Laboratory Supervision - (Sr. Chemist) Wet Chemistry Lab and Lab Data Systems - (1990 - 1998)  Responsible for SQL*LIMS System, Laboratory Instrumentation and Computer Systems, Validation of GLP Systems and reporting quality/compliance data to State and Federal environmental agencies (DEQ, Health Dept. and EPA.)  Maintained Standard Operating Procedures for Chemistry Laboratories. Laboratory Technician - Wet Chemistry Analysis, Organics Analysis (1985 - 1990) Community Affiliations:  Vice President - Bella Terra Foundation Therapeutic Equine Learning Program  Treasurer - Walking Horse Association of Michigan