SUMMARY:

IT professional with over 25 years of experience and a strong background in ensuring that the highest measure of software quality and integrity is realized. Maria is precise and mindful of the delicate balance between the need for meeting tight deadlines and the essential observance of maintaining integrity and quality of the product and its associated deliverables. The following qualities make her invaluable to any project team: strong attention to details, analytical, ability to work well independently and in a team, strong written and verbal skills, ability to focus on tasks while maintaining work ethics, and dedication to producing quality work.

TECHNICAL SKILLS:

Software: JIRA, DOORS, HP ALM, Teamcenter United, Trackwise8, IBM Cognos TM1, 10.1.x/10.2.x (Perspectives, TM1 Web), Coda, CTMS, SignIt, HP PPM (Project Portfolio Management), SAS Electronic Archival Utility, SAS Randomization Utility, Siebel (Now Oracle) eClinical 7.7.x, SQL*LIMS, Rode/PC

Programming Languages: PL/SQL, Developer 2000 Forms/Reports, SQLPLUS, C, Oracle Forms 2.3/30

Platform: PC, VAX/VMS

Operating System: Windows7, Windows XP, Windows 2000, VMS

Database: Oracle database 8, 7, 6, 7.3

Utilities: TOAD for Oracle 9.7.2.5, Microsoft SQL Server Management Studio 10.0, PPM

PROFESSIONAL EXPERIENCE:

Confidential, Deerfield, IL

Senior Principal Software Engineer

• Lead and develop the verification and validation tasks to maintain Baxter’s Sharesource web - based remote connectivity platform application In charge of the verification tasks
• Developed foundation plans for verification and validation
• Adhere to company quality policies and standards and governance
• Working with Lead Designer, Product owner, Quality Representative, and IT Development team to ensure proper verification and validation cloud technology - Sharesource portal in the Cloud; patient treatments from medical devices to Sharesource; patient treatment programs logged by clinicians to download to patient’s home device
• Hemodialysis and Peritoneal Dialysis Therapy devices for end-stage renal diseased patients
• Launch Sharesource in countries with multi-languages
• Highly visible projects to launch in competitive markets
• Baxter leader in PD in EU markets

Confidential, Deerfield, IL

Verification and Validation (V&V) Lead

• Oversee the third-party development team during verification phase
• Provide adequate documentation for verification and validation
• Coordinated with project team to launch two-factor authentication feature into European markets with CE marks
• Maintained qualified state of system for submission to the FDA in US

Confidential, Deerfield, IL

IT Business Analyst / Validation Coordinator

• Oversee the details during system testing of the data integration and consolidation work stream for a corporate global project to develop and implement improved financial planning and budgeting processes across business units
• Ensure that all issues/requests by the business are prioritized for the next change management
• Acquire an in-depth knowledge of the data model instituted in the financial consolidation application
• Manage client and stakeholder expectations to deliver projects on time and within scope
• Facilitate requirements gathering sessions with business subject matter experts to identify and evaluate the organization’s processes
• Work with technical team members to ensure that functional processes are accurately represented in the technical design of the application
• Author and maintain business and functional requirements documents
• Author system and User acceptance test scripts
• Oversee the execution of user acceptance testing
• Meet SDLC deliverables for both regulated and non-regulated systems

Confidential, Vernon Hills, IL

Validation Analyst / Tester

• Authored, dry ran, and formally executed test cases for the validation of a highly visible Quality System using Sparta’s Trackwise under very tight and delivery schedules without tolerance for deviations;
• Participated in peer review and analysis of test cases pre- and post-execution to ensure that test case objectives are met, aligned with the user/functional requirements, and traceability between appropriate requirements and test cases exists;
• Drafted and finalized qualification interim/final reports needed for Qualification closure

Confidential, Deerfield, IL

Lead Validation Analyst

• Established an in-depth knowledge of CTMS components according to the company’s intended use (such as site monitoring work flows, contacts/accounts management, payments management, etc.)
• Developed a strong understanding of the policies, standard operating procedures, and SDLC methodology
• Met with key business personnel to elicit and define the business and operational processes and thereafter establish the appropriate functional requirements to be presented to the software/development team for proper design of the system
• Established a liaison with business, technical, and clinical team members to prioritize and develop testable requirements, testing plans, and quality controlled scripts
• Utilized strong technical writing skills to effectively communicate with upper management to report scope, timeline, and implementation issues
• Complied with escalation procedure for issue resolution to prevent costly delays
• Ensured that the system is in complete compliance with 21 CFR Part 11 for electronic records and ICH regulations for monitoring processes
• Authored and reviewed all system test scripts and User Acceptance test scripts
• Provided guidance to the project team with all SDLC deliverables Served as Validation Analyst to validate a highly configurable HP Project Management and Time Tracking application
• Worked closely with the Project Manager and Software Quality Assurance on time estimates of deliverables
• Provided insight on how to organize, define, and document the User and Functional Requirements to ensure that requirements based on the SMARTER criteria (Specific, Measurable, Achievable, Relevant, Time-bound and Testable, Evaluate, Re-evaluate)
• Maintained a traceability matrix to ensure that traceability of the user requirements, functional requirements, and design specifications to the user acceptance test cases, system test cases and Installation and Operational Qualification, respectively; Served as Validation Analyst to validate several regulated applications residing on SAS
• Significant role in putting together the User Requirements and Functional Requirements for an electronic archiving system and randomization scheduling system to clearly define their intended use;
• Assisted the business in appropriately documenting the specifications and requirements to ensure they are accurate, specific, measurable, and testable.
• Created and modified existing system test cases to validate and verify that the Functional Requirements are met by the system/applications;
• Created and modified existing user acceptance test cases to validate and verify that the User Requirements are met by the system/applications;
• Reviewed and approved the Installation and Operational Qualification documents and oversaw the execution of these documents to verify that the system/application is installed and configured appropriately;
• Ensured that the validation documents utilized the appropriate document templates, and clearly documented the necessary information as defined by company policies and standard operating procedures.

Confidential, Round Lake, IL

Validation Analyst/Coordinator

• Served as a Software Validation resource to provide assistance in the qualification process of a computerized Global LIMS, to develop software programs for system conversions, to perform formal code reviews, and to develop strategic methodologies to enhance the support and documentation of the system subject to FDA regulations and approval
• Role of a Validation analyst to assist in developing and authoring a system configuration document to determine the technical requirements of maintaining a current manager system versus upgrading to a higher version of the system
• Conducted interviews with the business users and technical support personnel to determine the business processes and the current infrastructure
• As a Validation Coordinator, ensured the adherence and compliance to business procedures and regulations during the qualification of several system changes and enhancement
• As a Validation Lead, validated a computerized system that would allow the laboratory instruments to interface and securely upload instrument and raw data to the main laboratory system as well as to an archival system, and be made available for further data processing and analysis; Assisted in the completion of the User Requirements documentation; Developed a master validation protocol as guidance for the qualification of the system
• Closely worked with the project manager/leader to prioritize tasks and determine estimation of deliverables
• Served multiple roles as a technical reviewer, validation representative, tester, documentation author, and software programmer within a global project
• Authored system protocols, functional and system specifications to provide documentation and verified documentation trace-ability within the project life cycle as governed by business procedures and policies
• Authored system test cases to test and verify the integrity, security, and functionality of different processes throughout the system prior to deployment and implementation
• Executed system test cases using good documentation practices for regulated manufacturing and laboratory systems
• Received and maintained proper training to comply with company policies and standard procedures.
• Collaborated with document authors in improving divisional system procedures by making the necessary clarifications for effective statements
• Manually executed system scripts for a web-based Quality Director application
• Executed test scripts in automated fashion via Test Director Application
• Developed batch programs and data upload scripts for the implementation of an upgrade version of a manufacturing documentation system
• Performed corrections and enhancements to existing program codes of the current system
• Worked closely with system users to prioritize system change requests
• Provided technical support in maintaining the current system

Confidential - Round Lake, IL

Computer Programmer

• Lead Software Programmer responsible for supporting an upgraded version of a proprietary manufacturing documentation system.
• Developed and customized a proprietary Key Entry system application to allow users to securely upload data to the mainframe at their own discretion.
• Authored and maintained SDLC documents and User Materials
• Maintained and supported the current documentation system.