Quality Assurance Customer Service

Theresa Wright

*** ********** *****, ****, ** ***79

Mobile: 269-***-**** ( Home: 573-***-**** ( Email: **********@***.***

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Information Systems Management - Compliance Lead - Software Engineer

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Goal-oriented leader with over 20 years experience planning, developing and

implementing complex information systems and technical solutions across

multiple sites. Adept at re-engineering workflow processes and cross-

functional training to improve efficiency and increase cost savings while

reducing complexity and compliance risk. Expert in joint application

development, critical thinking, problem solving, technology integration and

customer demand discovery.

Over 12 years experience in a variety of IT Quality Assurance Lead roles,

including 6 years experience leading a Site IT Compliance Program for

Corporate QA. Established corporate Quality Standards, governance,

validation strategy, and implementation of compliance remediation programs.

Lead risk assessments and audits for 60+ computer systems and software

applications resulting in a success rate of 100% for regulatory and

internal audit outcomes.

Areas of Expertise:

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Compliance and Regulatory Programs Application and Portfolio Management

Quality Risk Management and Assessment Disaster Recovery/Business Continuity

Programs

Validated System Lifecycle (SDLC) Agile, Six Sigma, Lean QMS, SCRUM

Methodology Methodology

Compliance with GMP, GLP, 21CFR, ICH, System Analysis - Data Architecture

GAMP

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Technical Synopsis

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o ORACLE: Database and Application Server

o INTELLIGENCE: Oracle Developer Tools, Forms/Reports/Barcodes/DISCO,

Business Objects

o DEVELOPMENT: VBA, Visual Studio, Access DB, SQL Server, SQL, PL/SQL,

Toad, Java Beans, C+, .Net

o MODELING: Case Tools, Function Point Analysis, UML/Rational Rose, Rapid

Prototyping, JAD

o WEB: Web portal management and development, HTML, XML, Windows Server

IIS, Share Point

o SYSTEMS: Enterprise Level, Client/Server, Distributed systems, Robotics

and Interfaces

o LIMS, Lot Release, Stability, Environmental Monitoring, ERP-MRP,

Supply Chain Management, Relational Databases, Document Libraries,

Repositories, Archives and Network Storage

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Professional Experience

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Pfizer (1998 to present)

Information Systems Manager/Sr. Scientist, 2006-2010 (St. Louis, MO)

Technical services expert and critical support asset for 15-20 computer

systems used by Biopharma Quality and Laboratory Operations. Recruited to

partner across divisions to improve usability of centralized systems that

control cross-line workflows and local scheduling for Supply Chain,

Logistics, and Manufacturing groups.

o Optimized the validation process for an enterprise level SQL*LIMS system

upgrade. Reduced time frame for implementation and migration by 50% using

only 1 resource, maintained $0 budget and went live without issues,

deviations or post install triage.

o Tracked down elusive causes of recurring Oracle server crashes and

implemented preventive actions that completely eliminated unplanned

outages.

o Transformed a time consuming batch record review process by developing a

novel database application and "configurable" report (with modifiable

inputs) that reduced process time by 90% and eliminated errors.

o Developed a VB application using the Grubbs Outlier Test as an

alternative statistical solution after the approved Dixon Outlier Test

failed due to sample size. The solution was immediately adopted and

product was released on schedule.

o Restructured 3 vendor contracts (with no impact to service level) and

reduced support budget by 60%.

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Professional Experience - continued

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IT Quality Operations Engineer, Sr. Systems Analyst, 2005-2006 (PGM

Regional IT, Kalamazoo, MI)

Lead and facilitated cross functional teams assigned to support local

applications and centralized systems. Performed feasibility studies,

prepared budget projections, evaluated vendors and created statements of

work for proposed applications and functionality. Managed daily operations

and provided customer support for a variety of Business System Applications

and ensured that validation and change control documentation for production

systems was accurate and complete.

Quality Assurance Lead, QA/QC Consultant IV, Sr. QA Professional, 1998-2005

(PGM, Kalamazoo, MI)

Administered the Computer System Compliance program for Corporate QA and

Shared Systems. Developed Corporate Compliance Standards, Policies and

Procedures that established Best Practices for IT Governance. Developed

strategic direction to specify and build new systems and harmonize the

transition of legacy systems across multiple sites into global solutions.

o Managed a 21CFR assessment and remediation program that brought over 60

validated computer systems into compliance with new GMP regulations.

o Initiated templates and that organized and simplified the preparation

process for regulatory audits.

o Facilitated the qualification of standard desktop software for phased

rollout at multiple sites.

o Re-engineered and validated 70 custom LIMS components in 6 months.

o Established a Disaster Recovery and Business Continuity Planning program

for the local computer center.

City of Kalamazoo Water Reclamation Laboratory (1985 - 1998)

Sr. Chemist - Laboratory Supervisor, Data Systems Chemist

Recruited, hired and supervised staff of 8-10 Technicians, Operators and

Staff for the wet chemistry lab. Modernized laboratory operations with

automated instruments, data acquisition and data transfer interfaces.

o Built applications to generate Control Charts for trending and detecting

OOS results.

o Established validation protocols and procedures for reporting data to

State and Federal Environmental Agencies (DEQ, Health Dept. and EPA.)

Western Michigan University (1980 - 1985)

Physics Lab Instructor - (instructed 6-8 courses per year)

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Education

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Master's Degree in Computer Science - Grand Valley State University (2001)

Certificate in Information Systems Management (Project Management) - Grand

Valley State University (2000)

Certificate in Software Engineering (MIS) - Grand Valley State University

(1999)

Bachelor's Degree in Biology/Chemistry - Kalamazoo College (1979) - Thesis

- cloning E.coli plasmid DNA

Physics (completed master's degree coursework) - Western Michigan

University (1980-1985)

Clayton College of Natural Health Ph.D. program (2005-currently enrolled)

Mentored by retired FDA Inspector on system audit preparation (2001)

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Publications and Awards

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o Published "Segmented Flow Analysis" in Standard Methods, 20th ed.

(Methodology enabled labs across the US to automate ultra-low trace level

chemical analysis to meet EPA detection level requirements.)

o Chair of the Joint Editorial Board of Standard Methods for review and

update of editions 16 - 20.

o Pioneered Lab Analyst Certification Program as part of the Michigan Water

and Environment Federation (To establish credentials and levels for the

Lab Analyst Profession.)

o CQA Departmental Recognition for special service (1999) and Marketed

Products Recognition Award (2001)

o PGM-IT Six Sigma Deviation Management team recognition (2006)

o Recognized 14 times for exceptional customer service in optimizing

workflow processes (2006-2010)

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Community Affiliations

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Vice President - Bella Terra Foundation Therapeutic Equine Learning Program

Association for Manufacturing Excellence (AME) - Membership (QMS Quality

Systems)

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