SUMMARY

• Facilitating validated requirements, consensus building and translating to functional specifications and design requirements.
• Created test cases and validation documents following FDA guidelines, procedures and policies
• Apply IT and Compliance knowledge and experience to create, analyze and interpret user and functional requirements and design verification documents against test cases in a web environment.
• Wrote Test Plans for specific developed applications; Maintained all test cases and requirements in Quality Center (QC) & reported all defects
• Manage cross - divisional teams through the SDLC process; Adhere to all FDA policies, regulations, SOPs.
• Developed database applications in Sharepoint.
• Manage and coordinate UAT and integration testing on a project.
• Communicated status and weekly dashboard to project teams and management, managed project schedules
• Analyze and update FRS documents and trace matrix to compare testing coverage.
• Capture and report on IT Compliance data and metrics for assigned project tasks and identify potential process improvements.

TECHNICAL SKILLS

Languages: COBOL, C, SQL, Java (testing)

Applications: MS Project, MS Word, MS Excel, MS PowerPoint, Lotus SmartSuite, Notes, HEAT, WordPerfect, GroupWise, LMS, PROCOMM, Documentum, LIMS, Visio, Perfect Tracker, Beyond Compare, ISD, Version 1, Test Director, Mercury Quality Center 9.2 and 11.0, VICOR, TMS, Bugzilla, Maximo, ITSM, DIET, MKS, DOORS, Matrix 1, Register, IBM MAXIMO, Aris Global Register, Trackwise, Sharepoint, Discoverant (BI), ISOTrain, ServiceNow Change Management

Platforms: Windows 95, 98, NT, 2000; MS DOS, Novell NetWare, UNIX, Mainframe

Hardware: IBM PC and Compatibles, Mac

PROFESSIONAL EXPERIENCE

Confidential, North Chicago, IL

Software Quality Assurance Engineer

Responsibilities:

• Provide SQA lead services for regulated/non-regulated computerized systems assuring the systems adhere to Confidential ’s quality standards and applicable regulations throughout the system’s lifecycle
• Assure compliance function according the the SDLC
• Support IT systems owned by different divisions
• SLC deliverable review and quality approval of all validated project deliverables
• Compose system certification summaries for production implementation
• Corporate/Divisional Compliance Plan implementation and support

Confidential

Business Analyst/Validation Lead

Responsibilities:

• Leading the efforts in assessing needs and establishing processes and procedures for overall system change control and configuration management on Sharepoint sites
• Facilitating requirements, consensus building and translating to functional specifications and design requirements.
• Provide validation lead services with responsibilities over 4 testers

Confidential

Business Analyst

Responsibilities:

• Compose narratives for all pharmaceutical and device registration processes.
• Used Sharepoint for regulated documents and processes.
• Update URS documentation and any other deliverables deemed necessary for the project.

Confidential

Business Process Engineer

Responsibilities:

• Leading the efforts in assessing needs and establishing processes and procedures for overall system change control and configuration management.
• Facilitating requirements, consensus building and translating to functional specifications and design requirements.
• Leading the transformation of business process requirements into the design and development of system applications.
• Manage cross-divisional teams through the SDLC process.
• Used Sharepoint for regulated documents and processes.
• Create project/testing timelines.
• Manage and coordinate UAT and integration testing on a project.
• Code moves using the MKS application.
• Developed database applications in Sharepoint.

Confidential

Business/Validation Lead Analyst

Responsibilities:

• Apply IT and Compliance knowledge and experience to create, analyze and interpret user and functional requirements and design verification documents against test cases in a web environment.
• Review test cases, perform impact assessment.
• Review system documentation (test plans/strategies, other SLC documentation) in support of validation activities.
• Meet with clients to review and assure proper requirements are fully tested and documented, coordinate with the project team to develop UAT/Validation test plans, scripts and data for proper execution and writing of regression, user acceptance, and functional testing.
• Communicate and log issues that may delay the project or otherwise subject the company to financial or regulatory risk.
• Adhere to all FDA policies, regulations, SOPs; CFR Part 11 security testing.
• Analyze and update FRS documents and trace matrix to compare testing coverage.
• Complete project tasks within time and budget constraints.
• Capture and report on IT Compliance data and metrics for assigned project tasks and identify potential process improvements.
• Identify defects and report them to the development team, retest all defects upon resolution.
• Train and lead testers on validation testing and application knowledge, managed multiple project validation teams simultaneiously
• Write/Update technical training manual for a data warehousing project.
• Create test plan for Oracle 10g upgrade.