Data Entry Customer Support

Mark Levanites

SUMMARY

Data entry specialist with proven accuracy at 50WPM and a strong proficiency in Microsoft Office. Background includes processing and provisioning contracts with meticulous attention to detail. Experienced in supporting internal customers in fast-paced, professional environments. Reliable and committed with flexible availability, including Saturday work. SKILLS

• Data Entry & Administration: Data entry, IT and Software customer support

• Validation & Compliance: Computer systems validation, Compliance risk validation, Regulatory compliance (FDA GxP, 21 CFR Part 11), SOP standardization, Validation consulting

• Leadership & Management: Matrixed team leadership, Audit representation, Mentorship, Team management

• Technical Testing & Documentation: SDLC documentation, CAPA coordination, Test Cases, Training, Summary Reports, Support Documentation, Test plan creation, Test case creation, Bug tracking, Risk assessment, Functional/Integration/GUI Testing, Automated testing, Quick Test Professional, Win Runner, Requisite Pro, Track Record, Knowledge management platforms

• Software & Programming: Oracle AERS, Cyclone application, Laboratory Information Management System (LIMS), ATM imple- mentation, SAP migration and implementation, Software testing, SQL, TOAD, VB, VB .NET, Java, Delphi, Cobol, Informix, FlatFiles, SQL Server, Windows Server, AIX, C++, HTML, JavaScript, VBScript, Oracle, Windows 95/98/2000, Win NT, Mac OS, C, Visual Basic

• Project & Change Management: Authoring validation materials, Project Plan, System Impact Analysis, Change Control WORK EXPERIENCE: PFIZER AND OTHER PROFESSIONAL EMPLO¥œ•• Pfizer, PDM Aug 2017

Senior Scientist-Computer Systems Validation/Data Entry/Customer Support

• Executed accurate data entry of scientist information (50WPM) into applications and databases, utilizing Microsoft Office to ensure comprehensive data processing.

• Delivered IT and software customer support to 100 Pfizer scientists, addressing internal technical inquiries in a professional environ- ment.

• Directed the validation of compliance risk computerized laboratory systems, aligning with PDM IT strategies.

• Authored compliance risk validation materials in accordance with FDA GxP and 21 CFR Part 11 regulations.

• Coordinated with cross-functional PDM and DT teams to develop and execute components of the computer system validation package.

• Represented PDM compliance risk systems during regulatory agency audits and internal Pfizer corporate audits.

• Championed the evaluation and validation of PDM Compliance Risk Level I/II/III systems per the PDM Computer System Validation Risk SOP.

• Contributed to local and global PDM IT strategies, fostering cross-site communication and consistency.

• Mentored colleagues across the PDM organization to enhance team expertise and performance. Sequence Quality and Compliance Services Dec 2005 - Aug 2017 NE Business Development Manager and Sr. Consultant Raleigh-Durham, NC and Boston, MA Acted as NE Business Development Manager for Sequence Quality and Compliance Services, a leader in providing validation consulting services to the pharmaceutical, biotech, and medical device industries.

• Collaborated with clients to ensure complete regulatory compliance, contributing to the delivery of high-quality patient products through industry-leading service and ethical practices. Foundation Medicine Feb 2016 - Aug 2017

Validation/Business Analyst Cambridge, MA

Lead Validation/Business Analyst responsible for all creation, execution, and approvals of SDLC documentation for the companies Nautilus LIMS and integrated software applications in QSR and CLIA regulated environment.

• Lead CAPA coordinator for department ensuring all issues are corrected and actions are put in place to prevent in the future. Biogen Idec Dec 2012 - Nov 2015

Validation/Business Analyst Cambridge, MA

Lead Validation/Business Analyst responsible for all creation and execution of SDLC documentation for following applications:

• Empower - Successfully upgraded high profile Empower application at all global lab sites. Produced all SDLC documentation for project as well as working with Empower application business owners/users to execute and complete UAT Testing. Assisted in upgrading and converting Empower lab servers and instruments (HPLC, UPLC, GC) and completing date migration from legacy system.

• tranSMART - Knowledge management platform that enables scientists to develop and refine research hypotheses by investigating correlations between genetic and phenotypic data, and assessing their analytical results in the context of published literature and other work

• lifeIMAGE/inviCRO iPACS - Large, validated, cloud-based, multi-tenant, Medical Imaging Repository

• Subject matter expert and authored validation documents including Change Control, Project Plan, System Impact Analysis, User/Func- tional Requirements, Risk Assessment, Test Cases, Training, and Summary Reports, Support Documentation ensuring compliance with Biogen processes and regulatory requirements.

Grifols (formerly Talecris Biotherapeutics) Dec 2005 - Dec 2012 Senior Validation Consultant and Site Lead Clayton, NC and Raleigh, NC Upgraded and implemented Donor Management System at 150 plasma centers throughout United States

• Managed and lead team of 10 validation resources

• Lead Validation Analyst responsible for all creation and execution of SDLC documentation for following applications:

• Donor Doc (DMS) - A centrally hosted application/medical device used by DMS (Donor Management System) throughout approx. 150 Grifols centers to help donor centers evaluate donor suitability prior to drawing blood products by allowing them to electronically complete pre-donation health history questionnaire and track physical exams. Managed seven to ten validation resources to successfully implement DMS Software and Hardware.

• RDSS - An Oracle AERS based Regulatory Drug Safety System of the submission and creation of Product Technical Complaints and Adverse Events

• REDI - A Cyclone based application used as an electronic data interchange with Regulatory Authorities throughout the world

• LabVantage Sapphire LIMS - An Oracle based Laboratory Information Management System implementation across multiple sites.

• ATM implementation across multiple sites/centers.

• IS Quality System Consolidation Project which involved all organizations of Talecris and standardizing SOP's and templates

• SAP which involved migration of SAP data from Bayer to Talecris as well as implementation of SAP Canada and SAP Europe. Misys Nov 2004 - Dec 2005

Quality Assurance Analyst Raleigh, NC

• Perform numerous testing methodologies on healthcare software applications written in VB, VB .NET, Java, Delphi, and Cobol that use Informix, FlatFiles, and SQL Server databases. Software is run on Windows Server 2000, 2003, and AIX 5.2. Create test plans and test cases using Test Director and also use Test Director and Bug Tracking tool to report and validate defects.

• Key player on the Misys R&D team that was involved in developing products that are focused on acquiring and analyzing patient specific clinical information.

• Promptly provided risk assessments, time estimates and progress reports to management. PPD Jul 2004 - Aug 2004

Clinical Research Associate/Date Entry Raleigh, NC

• Performed data entry (50WPM) with great attention to detail and accuracy.

• Quality Control and Database Management for several clinical and case studies.

• Compare paper clinical study data to database entries documenting any/all disparities.

• Worked in a team environment as the final quality control before product release. Element K Apr 2001 - Jul 2004

Software Test Engineer I Rochester, NY

• Provided software testing and verification support services for web-based e-learning applications written using C++, HTML, JavaScript, and VBScript that use Oracle and SQL Server databases. Software was supported on Windows 95/98/2000, Win NT, and Mac operating systems. Create test plans and test cases using Requisite Pro and reported defects using Track Record. Created test scripts and automated test scripts using Quick Test Professional and Win Runner.

• Functional/Integration /GUI Testing on Element K and custom websites. Also used test scripts and performed extensive regression and automated testing using Quick Test Professional and Win Runner scripts.

• Performed database verification using TOAD and SQL.

• Lead tester, coordinated the test plans and effectively reported the test counts and results. Team player with good communication & teaming skills and highly motivated. Received numerous Peer to Peer and Team Member Awards.

• Projects have included custom websites for high profile companies such as Microsoft, Cisco, Kodak, Xerox, Adobe, Sunbelt, Gateway, New Horizons, and many more.

Xerox Aug 2000 - Apr 2001

Software Test Engineer Rochester, NY

• Developed detailed System Test Plans and Test Cases based on the Requirements/Architecture and the Design documents.

• Functional/Integration /GUI Testing on Xerox accounting applications written in C, C++ with Visual Basic, JAVA Script Environment, Oracle processing.

• Analyzed system documentation like Requirements document, User Interface Specifications to develop and Execute Test scripts, attended Change Request meetings to document changes and implemented procedures to test changes.

• Developed Test Plans with understanding of system flows and file relationships.

• Extensively used SQL to perform Data integrity testing Veramark Technologies Nov 1997 - Aug 2000

Software Test Engineer II Pittsford, NY

• Developed detailed System Test Plans and Test Cases based on the Requirements/Architecture and the Design documents.

• Functional/Integration /GUI Testing on Veramark's TMS application and customer applications.

• Company representative when licensing Veramark's products by Lucent Technologies. EDUCATION

St. John Fisher College 1996

B.S., Management/Human Resources

• Coursework: Management, Human Resources

PROFESSIONAL MEMBERSHIPS (IF APPLICABLE)

ISPE Boston Area Chapter and Board of Directors Dec 2013 - Oct 2018 Product Show Chair

• 2015/2016 ISPE Boston Area Product Show - Product Show Committee Chair

• 2014 Boston Area ISPE Product Show - Attendee Committee Lead.

• The Product Show Committee is responsible for organizing and coordinating all activities associated with the ISPE Boston Area Chapter Product Show, the largest one-day gathering of biotechnology and pharmaceutical professionals in New England. In addition to an exciting educational programs and keynote address, the Show offers attendees an unparalleled opportunity to network with industry peers and the Chapter's Board of Directors. With over 375 exhibiting companies and well over 2,500 attendees each year, the Product Show has earned its reputation as ISPE's best local show.

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