Quality Assurance Project

SANDRA SHADWELL

** ********* ******

Cedar Knolls, New Jersey 07927

Home: 973-***-**** Cell: 973-***-****

SUMMARY

Experienced professional with a practical and a solid understanding of business applications, QA Compliance and managing Systems Development Life Cycle (SDLC). Skilled analyst, adept at documenting business requirements, defining project scope, developing functional and technical specifications, and reporting to upper management. Known for a contagious passion for excellence, a talent for resourceful business solutions, and the capacity for motivational leadership. Accomplished at analyzing workflows, identifying areas of improvement, developing solutions, and maintaining a change control process. Working knowledge of the drug development process, 21 CFR Part11, Standard Operating Process (SOP), Sarbanes Oxley (SOX), and other related regulatory compliance guidelines.

EXPERIENCE

Specialty Boutique, New Jersey (Jan’10 – Mar’11)

Boutique Owner – (entrepreneur)

• Opened a new specialty boutique & oversaw the daily operations of the business.

• Effectively developed a business plan & budget.

• Creatively developed innovative marketing, advertising & sales techniques.

• Developed & implemented inventory system, accounting books & procedures.

• Studied the industry market and kept abreast of new trends.

• Maintained customer information databases.

• Trained new owner to maintain all aspects of handling the boutique responsibilities such as marketing, advertising, accounting, and inventory.

Cadbury, Whippany, New Jersey (Apr ’09 – Dec ‘09)

Global Project Leader – Technical Data Management

• Lead projects for the science & technology group on ensuring delivery, budget adherence, time and resources.

• Collaborated with system configuration teams to prepare project charters, work plans and assure timely solutions are developed meeting sponsors’ requirements.

• Lead and influenced cross-functional teams of business partners in ensuring the effective flow of information among all team members.

• Provided guidance and support to global data owners for data cleansing, harmonization and system implementation using SQL.

• Managed and facilitated bi-weekly status meetings.

• Drove change control issues to resolution.

• Developed system requirements, tested and evaluated new functionalities.

• Developed user acceptance test (UAT) plans.

• Developed and updated global technical data management processes as required.

• Developed analysis and audited scientific data using SQL.

• Provided consultancy to the business on data creation, enrichment and cleansing activities of data such as ingredients, packaging, formulas, and regulatory compliance processes.

• Tested & tracked changes of new applications added to SharePoint.

Avis Budget, Inc., Parsippany, New Jersey (Jul ’05 – Jan ‘09)

Database Administrator (Project Leader)

• Conducted interviews with line of business personnel to understand business needs and requirements.

• Developed workflow analysis and workflow processes.

• Assured compliance with Sarbanes Oxley requirements.

• Worked closely with the developers and designed solutions in SQL, which helps in the development of the software.

• Supported line of business in developing, managing, and executing quality testing procedures.

• Lead project with enhancements, developments, and rollout of Visual Lease Rental Software by utilizing a change control process.

• Lead and coordinated the UAT team in the ADP/SAP implementation.

• Developed the test planning process for ADP/SAP implementation.

• Ensured on-time delivery of testing deliverables for the ADP/SAP implementation.

• Maintained, reviewed and drove change control issues to resolution in the SAP implementation.

• Provided support to users with training / problems using SAP.

• Participated in other information management system development activities as needed.

• Supported the Finance Department in meeting their objectives.

Abbott Laboratories, Whippany, New Jersey (Apr. ‘04 – Jul ‘05)

Data Analyst/Quality Assurance (Contractor)

• Database Administrator for EduNeering compliance wireless software, which is used by the FDA.

• Provided support to customers with EduNeering training and problems.

• Managed the New Jersey Grants budget for training.

• QA compliance, analysis and reviewed manufacturing documents, specifications and validation reports for regulatory filings to the FDA.

• Reviewed and edited product assurance stability reports for FDA publication.

• Reviewed technical documentation (batch records, SOPs, protocols, reports) for continuity and accuracy.

• Effectively reviewed and analyzed scientific data collected from the quality laboratory.

• Gathered manufacturing data for pharmaceutical validation and assessments.

• Interacted with all functional areas of a manufacturing plant, while ensuring compliance with the FDA, DEA, OSHA and cGMPs regulations for the pharmaceutical products.

• Supported the Product Assurance, Manufacturing Science and Technology, and Training Departments in meeting their objectives.

Merck, Inc. & Co., Whitehouse Station, New Jersey (2002 – Nov. ‘03)

System / Business Analyst (Contractor)

• Supported the Enterprise Shared Area / Data Warehouse, as a quality assurance analyst, enabling problem solving by a variety of programming disciplines.

• Gather and documented business data requirements for over 40 clients’ whose applications require data about employees from the enterprise data warehouse.

• Interfaced with Data Stewards, HR, Finance, and Facilities, to expedite approval of subscriptions, while maintaining compliance with the international safe harbor regulations.

• Created Design Specifications based on the business requirements for subscribers of the Enterprise Shared Area.

• Developed views (data extracts) using SQL to be implemented by the DBA for subscribers of the data.

• Case Tool Administrator for Oracle Designer 9i & Oracle Designer 6.0.

• Responsible for maintenance, backups, and tuning of Oracle Repositories.

• Informatica Administrator: user creator, migration of folders, scheduler, etc.

• Analyzed Audit Trail Reports for quality assurance.

• Successfully documented mappings for the Enterprise Shared Area / Data Warehouse.

• Supported customers / subscribers in data quality assurance issues, by analyzing their data.

• Interacted with users in Human Resource, IS, Finance and other functional areas to maximize effective use of Enterprise Shared Area.

Pfizer / Warner-Lambert Co., Morris Plains, New Jersey (1976 – 2001)

Business Analyst (Project Leader) (1997 - 2001)

• Led project in the design, development, implementation & maintenance of a financial decision support system to replace outdated system and improve efficiency of the financial area. This was accomplished using a client-server architecture based system developed with Hyperion Essbase.

• Supported the operating division, as a systems resource, enabling problem solving by using expertise in a variety of programming disciplines.

• Hyperion Essbase Database Administrator and maintenance.

• Developed & conducted training of financial personnel for new systems and software applications.

• Interacted with users in Finance, IS and other functional areas to maximize effective use of hardware & software through creative training and program initiatives.

• Tested & implemented systems to ensure maximum effectiveness & prepared appropriate user & technical documentation for all systems & programs as developed.

• Acted on own initiative as Data Base Administrator (DBA) on the RS6000 due to absence in IS Department.

• Ensured integrity of financial data within control of the Department & maintained consistency with data outside the Department.

IS Development Analyst (1992 - 1996)

• Led project in the design, development, implementation & maintenance of a financial decision support system, replacing old system and improving efficiency using a client-server architecture based system developed in PowerBuilder, Sybase, Unix and Proprietary Software, Axysys.

• Tested and implemented systems & prepared user & technical documentation for the financial area.

• Downloaded data from the data warehouse systems for management use & maintained database integrity.

• Provided support for the maintenance of existing systems & programs as required.

Financial Analyst/ IT Coordinator/Various Other Positions (1976 - 1991)

• Developed & coordinated computer programs for the Finance Department.

• Developed, maintained & controlled the Inventory Reserve passing audit during entire tenure.

• Developed, maintained & prepared Inventory reports for senior management.

• Maintained & controlled the MAPS system.

• Created and implemented an automated Logistics Business Review process saving the company four days lead-time.

• Trained the Finance Department in the use of the AMAPS Cost System.

• Analyzed G/L Accounts, prepared monthly Journal Entries & reconciled Personal Accounts.

• Handled the Accounts Payable process for vendors.

TECHNICAL SKILLS

Operating Systems: Microsoft Windows, Microsoft NT, Microsoft XP, HP Unix, AIX/Unix

Programming: SQL Plus, COBOL

Software: Quest SQL Navigator 4.2, ADP Enterprise HR, Visio, Microsoft Project, Excel, PowerPoint, Word, Lotus Notes, Cognos, Sybase, SAP, Vantive, Clear Quest, Documentum, Informatica, Oracle RDBMS, Oracle Designer, Essbase, Oracle Financial Analyzer, Hyperion OLAP, Optiva, Sharepoint

EDUCATION

Fairleigh Dickinson University, New Jersey

• Bachelor of Science Degree (February, 1996 – Major: Business)

• Graduated Cum Laude (Major: Business; Minor: Computer Science)

Certificate: Six Sigma

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