Nine (*+) years experience of CSV validation and operational support; fifteen (15+) years experience with quality systems and quality testing; Well-rounded background, including project management, validation, technical writing, work flow development, and testing of USP, BP, EP, and JP requirements within a Quality Control/Quality Assurance/Information Technology environment. Over 7 years experience (7.5+) with LIMS (SampleManager LIMS) and over 10 years (10+) experience with the Empower Chromatography Data System

PROFESSIONAL EXPERIENCE

IT CSV Consultant

Validant Consulting, Inc. (January 2013 - Present)

Professional Achievements:

Project (January 2013 – August 2013): Johnson & Johnson Pharmaceuticals, McNeil implementation of Symphony ETQ Quality Management Information System: Role: CSV Tester

Project (August 2013 – April 2014): Johnson & Johnson Pharmaceuticals, McNeil implementation of the Waters Empower 3 Chromatography Data System: Role: Empower 3 Subject Matter Expert & CSV Test Lead

Project (June 2014 – November 2014): Mylan Pharmaceuticals, Minitab Upgrade to Version 17: Role: CSV Consultant (Examining business process, generating deliverables, writing and executing all test scripts)

IT Software Engineer, GxP Systems / Project Facilitator

Hisamitsu (Noven) Pharmaceuticals, Miami, FL 33186 (April 2010 – October 2012)

Professional Achievements:

Developed a plan to streamline static data review of the LIMS and Empower 2 CDS

Developed flowcharts to properly align the business with the paper-less lab concept

Developed Responsibility Matrices to align IT maintenance, Metrology maintenance, and business unit maintenance of the quality software systems

Project Management Lead for enhancement of all quality software systems

Acting Project Manager (LIMS) / Quality Systems Administrator

Hisamitsu (Noven) Pharmaceuticals, Miami, FL 33186 (August 2006 – April 2010)

Professional Achievements:

The Validation of SampleManager LIMS (setup all master data, wrote test scripts, acted as lead for project to complete project on schedule and within budget, systems administrator after go live)

The Validation of the Empower 2 Chromatography Data System (configured and validated all Custom Fields; wrote the entire PQ)The Validation of the Citrix Interface with Noven infrastructure (configured Empower 2 and SampleManager LIMS for Citrix)

The Validation of the Rees Environmental Monitoring System (wrote all validation deliverables)

The Validation of the Orbis Empower-SampleManager LIMS interface version 4.0 (configured a full 10,000 record mapping record)

Streamlining Static Data (Master Data) Review

Automation of all calculations

Continuous management of change control to meet user needs with a focus on maintaining the validated state of the LIMS system On-Time and On-Budget

Maintenance of the LIMSLink between Waters Empower and SampleManager LIMS to increase transfer efficiency from minutes to seconds

Maintenance of the Empower CDS Software to allow for maximum efficiency with the LIMS system and to comply with Noven SOP’s and STP’s, USP, EP, and JP testing requirements

Validation and Implementation of Electronic Signatures for Waters Empower in order to further the “paper-less” lab concept

Associate Scientist / Subject Matter Expert for LIMS Project

Hisamitsu (Noven) Pharmaceuticals, Miami, FL 33186 (May 2003 – August 2006)

Professional Achievements:

Perform Stability testing of the new Methylphenidate Patch to help gather data to launch the new Daytrana Patch

SOP for the reporting of Impurities to incorporate the new policies of ICH Q3a and Q3b

Organization of all validation activities in order to expedite “Go-Live” of the new LIMS system

Validation of custom calculations for the Waters Empower CDS

Validation of the mapping record between the Waters Empower CDS and the SampleManager 2004R2 LIMS system utilizing the Orbis SM-Millennium Interface

Validation of “Result Sign-off” electronic signatures for the Empower CDS

Evaluate 21 CFR Part 11 compliance of LIMS system

Test all User Requirements and write the Requirements Traceability Matrix

Collaboration with Quality Control, Quality Assurance, and Information Management in order to implement and test all new User Requirements

Chemist I / Chemist II

Teva (Ivax) Pharmaceuticals, Miami, FL 33178 (August 1999 – May 2003)

Professional Achievements:

Testing of Active Raw Material, Finish Products, and Excipients to meet Quality Control requirements

Calibrations of instrumentation

Process Validation and Method Transfer Protocol execution

Validation of spreadsheets to increase work flow efficiency

Creating custom calculations and reports for the Perkin Elmer TurboChrome CDS

TECHNICAL PROFICIENCES

Programming Languages:

oVGL (ThermoFisher proprietary language),

oSQL (for Oracle, SQL Server),

oPL/SQL (Oracle Proprietary Language)

Software:

oMicrosoft Office Suite (2007, 2010, 3013) and Microsoft Project (1 year experience)

oMasterControl Document Management System (1 year experience)

oTrack-IT Incident Reporting System (5 years experience)

oSampleManager Laboratory Information Management System (LIMS) (7.5 years experience)

oEmpower 1, 2, 3 Chromatography Data System (10 years experience)

oSymphony ETQ Quality Management System (9 months experience)

oOrbis SampleManager-Empower Interface (7 years experience)

oCybase Infomaker (7 years experience)

oMinitab 17 (7 months experience)

Miscellaneous Skills:

oFull SDLC lifecycle (GAMP 5 and FDA perspective)

oTyping: 60 WPM

oCSV Technical Writing (SOPs, test scripts, protocols, traceability matrix, URS)

oProject Management Principles (PMP Certification)

oSpanish (Fluent)

EDUCATION AND CREDENTIALS

Bachelor of Science in Biology (Minor in Chemistry)

Florida International University - Miami, FL (1997)

Masters of Science in Information Systems

(Concentration in Decision Support Systems and Business Intelligence)

Strayer University (2012)

Technical Training

oAdministration of SampleManager LIMS

oPrinciples of Computer System Validation (GAMP 5)

oWaters Empower 2 Systems Administration and Configuration

oLIMS Reporter 9 (Cybase Infomaker Report Generator)

oMasterControl Document Management System Administration

oLabWare LIMS V6 Administration

oLabWare ELN Templates Administration

oSQL Server 2008 Management Studio

oSymphony ETQ Quality Management System

oWaters Empower 3 Fundamentals, Systems Administration, and Configuration

oHP Quality Center

Certifications

oPMI’s PMP Project Management Professional

oITIL Foundations

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