SUMMARY

• Extensive experience in software development, implementation, and validation. Proven ability to manage full project development life - cycle. Knowledgeable in GMP and Part 11 compliance.IT QUALITY SYSTEMS BAG&W Laboratories, Piscataway, New Jersey
• Managing integration of corporate TrackWise system into acquired business unit. Enhanced existing TrackWise modules to support new customer base and developed Annual Product Review module. Work includes requirements gathering, design, configuration, testing, and validation.
• Trained staff in use of TrackWise modules.
• Managing implementation of ComplianceWire LMS in acquired business unit. Work with Quality, IT validation, and vendor.
• Coordinating two vendor groups in development of data feed from EDMS to ComplianceWire LMS to maintain up-to-date SOP training.
• Building metric feeds for Oracle BI from teh TrackWise database.

PROFESSIONAL EXPERIENCE

BUSINESS ANALYST

Confidential, Branchburg, New Jersey

Responsibilities:

• Developed Unified CAPA module to merge Quality Investigation, CAPA, and TEMPEffectiveness Check modules into a single streamlined module. Work included requirements gathering, design, configuration, testing, and validation.
• Developed module for tracking registration of new suppliers. dis moved a labor-intensive, paper process into an electronic system that reduced lost or duplicate requests and shortened processing time of a request from weeks to days. Work included requirements gathering, design, configuration, testing, and validation.
• Defined user requirements and prototypes for Document Numbering and QC Floor Inspection projects.
• Trained staff in use of TrackWise modules.
• Developed Java applet to retrieve controlled documents from EDMS and display in Web page.
• Work with Quality Training team to define training curricula and training strategies.
• Developed ETL scripts from TrackWise Training Manager to support import of records to ComplianceWire LMS. Performed imports of these datasets to ComplianceWire and supported validation of these imports.
• Created and managed set of Discoverer reports for Quality Training and Customer Solutions metrics.
• Led project teams to develop Quality Top 5 Metric and Project Portfolio Management dashboards.
• Worked with IT management to define SDLC procedures.

QUALITY SYSTEMS ADMINISTRATOR

Confidential

Responsibilities:

• Defined user requirements and prototypes for Document Revision and Engineering Change Control modules.
• Developed modules for Complaints, Nonconformance/Deviation, Field Return Authorization, and a suite of Supplier Quality functions. Work included requirements gathering, design, configuration, testing, and validation.
• Directed upgrade from release 7.1 to release 8.2. Work included project planning, interfacing with IT staff and vendors, installing and testing software upgrades, and supervising validation analyst and developer.
• Directed implementation of Training Manager sub-system. Work included gathering requirements and supervising validation analyst and developer.
• Validated and implemented modules for Quality Investigations, CAPAs, TEMPEffectiveness Checks, and Complaints.
• Implemented ETL processes from Oracle data warehouse and EDMS into TrackWise lookup tables.
• Designed ETL export datasets from legacy R&D systems to be used as static import for TrackWise R&D modules.
• Created and managed Discoverer reports for TrackWise metrics.
• Built Oracle Discoverer EUL to support TrackWise reporting. Defined custom queries, folders and reports.

Confidential

SENIOR PROGRAMMER ANALYST

Responsibilities:

• Installed TrackWise software on database and application server instances.
• Executed Hardware/Software validation protocols for TrackWise installations.
• Data Warehousing and Reporting
• Created data warehouse for tracking receipt of raw materials through production, quality assurance, sales, and shipping. Data was retrieved from legacy Btrieve system and live Oracle EBS and consolidated into Oracle tables
• Created ETL processes from legacy systems to Oracle EBS.
• Built EDI exports for distributors and governmental agencies.
• Created packages of reports for auditors and documented department policies to support them.
• Built Cognos cubes for sales reporting.
• Delivered clean data sets for product recalls.
• Automated a manual process to generate daily sales reports and email them to field sales force.
• Served as Administrator for Oracle EBS and DBA for SQL Server databases.
• Maintained legacy database applications.
• Provided departmental and end-user support for Oracle and legacy systems.

SOFTWARE CONSULTANT

Confidential

Responsibilities:

• Maintained Access and Visual Basic database applications.
• Healthcare (Robert Wood Johnson University Hospital)
• Built applications to automate processes to FTP, format, and email files, track time by project and user, block unauthorized access to patient data, track application testing, and track SQL Server access. Created Access and SQL Server based import/export utilities. Wrote specifications for data and user migration policies. Wrote user guides to network services.
• Pharmaceutical (Pharmacia)
• Developed document management system for a Global Forecasting group. Features included check in/check out of documents, compression of archives, comprehensive audit trail, and reports. Wrote user and administrator guides.
• Environmental Monitoring (Amega Scientific)
• Implemented a temperature monitoring system. Tasks included configuration display, TCP and UDP communication routines, database querying and tuning, and installation packaging.
• Landscaping Management (Florence Landscaping Service)
• Created workflow management system. Base functionality included worksheet entry and maintenance of database tables.
• Inventory Management (Chemlogix IMS)
• Designed and built a Data Import/Export/Transfer system for monitoring inventory of liquid storage tanks. Its functionality included a process scheduler and generic import, export, and transfer modules driven by customer defined templates.
• Telecommunications (Lucent Technologies)
• Developed GUI for managing an optical fiber network tracing product. Created a prototype front-end for managing teh connection and testing of jumpers in an optical fiber distribution frame.