SKILLS SUMMARY

• Project Manager, Business/System Analyst and Senior Consultant with more than 13 years of experience in the regulated industry. Expertise in Analysis, Design, Development and Implementation of software applications.
• Passionate about Quality Systems and Customer Satisfaction. Specialized on Laboratory Information Management Systems, quality assurance, regulatory compliance and business process.
• Strong background in system/business analysis, project management, process mapping/re - engineering and system implementations in the Life Science industry, user training and support documentation. Experience in major programming languages, operating hardware and software.

PROFESSIONAL EXPERIENCE

Confidential

Information Technology Consultant

Responsibilities:

• Site lead support responsible for the implementation, development, qualification and training of the Core LabWare LIMS implementation
• Training the Laboratory and Manufacture resources on the LIMS Core Laboratory workflow to log lots and samples, assign testing, enter results, perform reviews, generate labels and reports, create and close investigations, perform the stability workflow as well as retentions workflow among others workflows.
• Create and deliver the Computer Systems Lifecycle implementation documents (Site Validation Plan, Risk Analysis, Impact Assessment, Gap Analysis, IQ, OQ, PQ, Summary Reports, TM, System Decommissioning among others)
• Develop new control functionalities on master data objects like format calculations, subroutines or coding on analysis configuration.

Confidential

Technical Consultant

Responsibilities:

• LIMS Project Manager of the site. Lead the new LIMS implementation of STARLIMS V10. Perform user requirement definition, evaluate, test and modify the prototype provided by the STARLIMS. Develop validation plan for STARLIMS V10, IQ for production environment, OQPQ for publishing reports, OQPQ development by units and project plan. Responsible for the project management, database administrator, application developer, requirement definition, develop validation documents and master data builder lead.
• Provide support to the legacy LIMS system (STARLIMS V9) with the laboratories operations and the medical examiners operations (Pathology, Toxicology). Develop with new LIMS reports, workflows automation through new LIMS applications development with Microsoft SQL 2003 database design, administration and management. LIMS Reports development using Crystal Reports. Develop, Test and Implement new LIMS functionalities to support Laboratory operations.
• Develop Software Development Life Cycle documentation on new LIMS functionalities implementations and new LIMS version implementation (User requirement specifications, Validation Plan, Test Scripts, etc)
• Provide support to the ICF’s web page on new design and development. Initial assessment to implement an Intranet.

Confidential

Business Analyst / Validation

Responsibilities:

• Provide remote/local support to the Labware activities to tree separated sites (Pharmaceuticals on Carolina and Guayama and Consumer Products at Guayama) Use of several tools for remote support to the local operations using Netmeeting, Webex, Microsoft Communicator, etc.
• Provide support and troubleshooting to the Labware Configuration for Consumer Products and Pharmaceuticals at two sites located at Guayama PR to develop new approach on Complex reports (on Crystal Reports) like Generic NDA report, generic Certificate of Analysis and Certificate of Compliance.
• Implement Generic Objects for Packaging Components at the Carolina, PR site. Troubleshooting and development of the codes for Packaging Components on LIMS Basic. Develop Crystal Report templates and integrate them with Labware LIMS. Also the lot template requires modifications using LIMS basic.
• Improve the Environmental Analysis Configuration at Carolina, PR to include additional information not implemented at the Core Function workflow like several sampling time per sample depending to the desired components.

Confidential

LACES Member

Responsibilities:

• Meet with the Quality Assurance Department users to define requirements to automate the Certificate of Analysis for all the site products and their markets and specifications. Define requirements for the LACES LIMS reports, responsible for the development of Crystal Reports templates and the configuration to integrate it to the labware LIMS using access routines and query tags. Also the development of the Stored Queries to provide support to the metric statistical performed monthly by the laboratory areas. Develop several complex reports like the "Anual Product Review", "Instrument Performance Report", "Product Specification Verification", "Chain of Custody", "Samples for discard", "Retain Pull Samples Report", "Stability Forecast Report", "Inventory Material List Report", "New Drug Application (NDA) Report" and some other labels.
• Develop Labware configuration to work on Reports to show samples, test and results from old legacy SQL LIMS and the corresponding actual Stability data on Labware LIMS, Troubleshoot the label development for stability samples
• Evaluate current process flow and identify opportunities for improvement.
• Author and review technical and/or validation documentation.

Kelly Scientific

2/08-06/08

QA Specialist at Confidential Guayama PR

• Interface with System Owners, End Users, such as Computer Validation and Corporate Quality Assurance, as needed.
• Review and approve technical documentation and procedures.
• Plans, coordinates and participates in a compliant validation process, including 21 CFR Part-11, for quality information technology systems which require formal validation documentation under appropriate federal regulations.
• Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, follow low-level information to a general understanding, and distinguish user requests and the true needs.
• Provide guidance base on experience regarding enterprise-wide requirements definition, management systems, methodologies required or process re-engineering
• Drive and challenge business units on their assumptions of how they will successfully execute their plans
• Serve as a liaison between the business units, technology teams and support teams
• Align and reviews requirements, specifications, business processes related to proposed solution.
• Ensures issues are identified, tracked, reported on and resolved

Confidential

Senior Consultant

Responsibilities:

• Validation team lead responsible for the qualification of the Core LabWare LIMS site implementation, the Instrument Interface and the Wyeth new Labware LIMS Releases
• Develop core functionalities like sample management, standard and reagent, project management, development of analysis and components objects (Assays, Water Content, Environmental, etc), folders and reports.
• Derive requirements using interviews, document analysis, site visits, business process descriptions, use cases, scenarios, business analysis and workflow analysis
• Perform development on Instrument Interface using LIMS Basic to obtain the readings directly to LIMS using parsing scripts on digital calipers, balance via RS232 configuration
• Create and deliver the Computer Systems Lifecycle implementation documents (Validation Plan, Risk Analysis, Impact Assessment, Gap Analysis, Vendor Assessment, Cost/Benefit Analysis, URS, FRS, Design/Configuration Specification, IQ, OQ, PQ, Summary Reports, TM, System Decommissioning among others)

Confidential

Senior Consultant, Technical Lead

Responsibilities:

• Technical lead for Chromatographic Data Acquisition System (Empower). Responsible to provide support to the design of high availability architecture compatible with the Empower environment
• Responsible to drafting the Technical System Design document for the Empower High Availability System
• Develops functional specifications and system design specifications
• Collect information to analyze and evaluate existing or proposed systems.
• Recommend how to change or modify an existing system design

Confidential

Senior Consultant, Project Manager

Responsibilities:

• Served as a project manager leading computer system validation for the manufacturing controls and the clean in place / wash in place controls at the new Duloxetine Kit#3 manufacturing facilities at PR1
• Perform troubleshooting activities: On a real-time basis, identify problems, determine root cause and develop solutions independently or as part of a team for issues that arise during production and testing
• Responsible for the second phase of the Site Acceptance Testing (SAT) executions and the Installation and Operational Qualification (IOQ) executions
• Supervise around 4 to 10 consultant resources during the entire project, Manage project budget of $700K.
• Interface with consultants and technical support from vendors.
• Creates and executes project work plans and revises as appropriate to meet changing needs and requirements
• Ensures project documents are complete, current, and stored appropriately
• Tracks and reports team hours and expenses on a weekly basis,
• Keep a detailed "to do" list along with a project timeline
• Document scope of work and job requirements for all new and existing programs
• Monitor progress in terms of the status of the plan and the budget and report back to the senior management or the client, via weekly or other progress reporting or managing status meetings
• Anticipate and catch deviations from a plan or schedule early and keep all participants and stakeholders informed.
• Able to create and use Gantt charts, spreadsheets or other appropriate tools to manage people and tasks and keep up-to-date.

Confidential

IT Senior Consultant

Responsibilities:

• Served as an IT senior consultant performing the computer system validation for new Atomic Absorption laboratory systems
• Responsible for the retirement of legacy laboratory systems (Microlog and Atomic Absorption)
• Develop procedures for computer image management (creation, change management and disposition)

Confidential, Carolina PR

Quality Systems Computer Applications System Administrator

Responsibilities:

• Provide support to the Carolina, Puerto Rico laboratory operations and simultaneously provide support to the Corporate Development Team to a new implementation of Labware LIMS and Empower Chromatography Acquisition System at Pearl River, NY and the develop of training materials documentation kit on Empower Chromatography Systems at Great Valley, Pennsylvania.
• Develop the analysis and components configuration on Labware LIMS for Assay Analysis.
• Responsible for planning, leading and executing technical activities related to the implementation and production support of the new labware LIMS and the retirement of the legacy SQL LIMS.
• Perform administration functions for Quality and Laboratory systems like Turbo Chrom Chromatographic System, SQL LIMS, etc. Maintain system logs and documentation, user account management, report development, laboratory investigations and computer systems updated and Computer System Validation (CSV).
• Designing and writing code for reporting development

Confidential

Information Systems Specialist

Responsibilities:

• Responsible to validate LIMS implementation approach starting with the LIMS configuration on a separated site and the server transference to the Puerto Rico site and installation / validation.
• Provide support to the change management to evaluate impact of potential changes to the system & related applications. Provide support to the HPLC instrument acquisition system (Total Chrom & Turbo Chrom) and keep them updated and on-line.
• Troubleshoot the instrument connectivity and document maintenance on terminal servers.
• Manage user accounts, train new users on Turbochrom Data Acquisition System roles.

Confidential

LIMS Administrator, Project Manager

Responsibilities:

• Responsible for the improvement on new technology at the laboratory as well as the development of new proposals submitted to the Federal Government to obtain Funds
• Served as project manager responsible for the implementation of Laboratory Information Management System (StarLIMS L.I.M.S.USA) for a complex laboratory area (DNA, Toxicology, Trace evidence, Serology, Ballistic, Controlled substances and Pathology)
• Lead the system definition and the development of the LIMS prototype through user interviews with the LIMS developer engineers and each laboratory area represented by the users. Derive requirements using interviews, document analysis, site visits, business process descriptions, use cases, scenarios, business analysis and workflow analysis

Confidential

Chemist

Responsibilities:

• Served as a trace evidence chemist responsible for the analysis of evidence as well as testifies on court regarding to the case results
• Responsible for the use of laboratory instrumentation like UV, IR, HPLC, GCMS, AA, etc
• Responsible of trace detection of metal residues, drugs and fire accelerant substances

Confidential

Chemist

Responsibilities:

• Served as a chemist responsible for the analysis of steroids and antibiotic samples
• Responsible to provide support to the in-process steroid and antibiotic manufacturing plant
• Responsible for the use of laboratory instrumentation like TLC, UV, IR, HPLC, AA, etc
• Responsibilities include bench type analysis and chromatography determinations

Confidential, Barceloneta PR

Validation Chemist

Responsibilities:

• Served as a validation chemist responsible for the analysis of the antibiotic samples
• Responsible to provide support to the in-process antibiotic manufacturing plant
• Responsible for the use of laboratory instrumentation like TLC, UV, IR, HPLC, AA, etc
• Responsible for the validation summary reports after every cleaning process at the plant

TECHNICAL SKILLS

Trainings and Certifications: StarLIMS V9 and V10 Admin(Certified by LIMUSA), Labware, SQL LIMS, Empower (Certified as System Admin among others), TotalChrom (Some certifications from Perkin Elmer), Chemstation, Oracle 9i, Microsoft SQLSkills: Database design, management and tuning. Rapid Design Applications, Software design and development, System Architecture, software testing and database backend and front end connection.

Programming Languages: Visual Basic and .Net, LIMS Basic, PL-SQL, C++, LIMS Basic

PC Software: Microsoft SQL, Microsoft Access, Microsoft Office, Microsoft Visio, Microsoft Project, Visual Basic, PLSQL, Oracle Reports, Oracle Forms, Authorware, Brio, Crystal Reports and other reporting tools as well as several .Net applications from Microsoft like C++ and Visual Basic.