- Extensive experience in software development, implementation, and validation. Proven ability to manage full project development life - cycle. Knowledgeable in GMP and Part 11 compliance.
- Developed Unified CAPA module to merge Quality Investigation, CAPA, and Effectiveness Check modules into a single streamlined module. Work included requirements gathering, design, configuration, testing, and validation.
- Developed module for tracking registration of new suppliers. This 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 Confidential modules.
- Other projects
- 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 Confidential 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
- 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, Effectiveness Checks, and Complaints.
- Implemented ETL processes from Oracle data warehouse and EDMS into Confidential lookup tables.
- Designed ETL export datasets from legacy R&D systems to be used as static import for Confidential R&D modules.
- Created and managed Discoverer reports for Confidential metrics.
- Built Oracle Discoverer EUL to support Confidential reporting. Defined custom queries, folders and reports.
SENIOR PROGRAMMER ANALYST
- Installed Confidential software on database and application server instances.
- Executed Hardware/Software validation protocols for Confidential 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.
- Other projects
- 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.
Tools: Confidential and utilities, Crystal Reports, Oracle, PL-SQL, Oracle Discoverer, Cognos, Visual Basic, SQL Server, MS-Access