OBJECTIVE

Assist Pharmaceutical Information Technology with a proven record in project management, quality of deliverables, and business analysis, through strong demonstration in organization, leading tasks, product development, technical writing, and technical training, including customer service, and communication skills over 30 plus years of successful, profitable, and self-driven abilities. Please navigate through my expertise highlights and professional experiences to see many of my skillsets.

EXPERTISE HIGHLIGHTS

• FDA regulated environment for the Pharmaceutical and/or Medical Device industries
• DCO/Document Control Management, CS Computer System Validation
• Technical writing, Business Analyst BA , Protocol Writing, Requirement Gathering Writing IQ, OQ, PQ , Change Control process
• IT/IS Support, eCRF/EDC, Medical Terminology ICD Codes
• SOP's Procedures, CAPA Corrective and Preventive Actions
• FDA Part 11 Compliance, Training and Development, Clinical and Laboratory Practices GCP/GLP/ICH
• Statistical Reports, Documentum EDM, Software Development Life Cycle SDLC , CRFs/DCF Management, QA Validation
• CRO Liaison, Multi-tier /Web base applications
• Project Management, ISO Standards, Data Management Statistical Techniques, Regulatory Compliance/ submissions
• Quality Assurance QA , QA Audits, Phase I-III Clinical Research, Drug development
• JIRA Admin, SSRS Report Manager , Database Design Management, DB2 DB1, SQL Server
• Offshore Teamwork with company global locations- development teams, developers, vendors
• Agile Waterfall Business Process Methodology, Validation Plans/Script Writing, System Validation and 3rd Party Integration
• FDA regulated GxP Compliance and International regulations applies to all phama/bio-tech professional experiences performed

SOFTWARE TECHNICAL EXPERTISE

Microsoft Office Professional Engineering File Management System EFMS EE Work Manager McLaren AutoCAD DocSpace Adobe Acrobat Appligent Appendo Pro Development builds Servers Schema Stored procedures Snag-It UNIX VAX/VMS Crystal Reports Visual Source Safe vss Seapine PVCS Tracking System eClinical JIRA SharePoint Training NextDocs Multi-tier Internet applications Net technologies Oracle Clinical JDEwards Dream Writer Internet/Intranet Documentum 7.0 DOS Management System Eroom HTML/XML/XML Databases SQL Arbor text Authoring ISO9000 Networking/Window Security Databases/Validation or Test Environments Visio Desk Top Publishing applications Manual/Automated Testing Rational Requisite Pro Mercury Suite Web Applications Windows Processors Web Services and Databases Report Manager WebEx Training Document Control Manuscript DocuSphere

TECHNICAL TRAINING CERTIFICATIONS

Quality Center EFMS SAS/SQL Institute SOPs Requirements Management Validation/System Acceptance Testing Unit and Integration Testing GxPs Compliance: Good Clinical Practices GCP , Good Laboratory Practices GLP , Good Manufacturing Practice GMP Clinical Trials Continuous Data Flow Root Cause Analysis FDA Regulations Documentum Images/Management Systems Detecting and Handling of Questionable Data in Clinical Research Six Sigma Quality Systems Regulation QSR Promoting Medical Devices Biologics Imaging Manufacturing Quality System Records Regulatory Compliance Technical Writing Microsoft Office Professional e CRFs Microsoft Access Microsoft Project CAPA SOX Regulations ISO Regulations Visio

PROFESSIONAL EXPERIENCE

Lead Technical Writer/Doc Control Expert and Translations

Confidential

• Leading Technical Writer for DePuy Synthes in the Corporate Document Control Department CDC providing support to internal business work streams on document creations and revisions related to SOPs, Training, Work Instructions, and Forms, PowerPoint, FDA/GRQP CAPA and various document types.
• Ensures documents meet CDC document text standard work instructions, and DePuy Synthes quality compliance. Ensuring the documents are in the CDC document template, including DCO number assigned, correct footers display, revision history is present, and the format styles and grammar is satisfied.
• Performs revisions to regulated documents downloaded from Document Control System, as well as utilize Visual Safe Source VSS to own the document for revision.
• Verify documents current metadata in Manuscript, to check correct revision number matches up with the document being revised or other information that may apply.
• Create new document types for assigned work streams, communicate daily to gather project requirements and utilize related documents associated to create an effective document.
• Support CDC team with document reviews in preparation for document releases to ensure the CDC standards is adhered to.
• Lead and support CDC translation requests and the liaison between TransPerfect, Inc., a Global Translation Company submitting final documents for translation in bilingual languages. Maintain a Translation Tracker sheet with of submitted pre- and post- translations. Utilize TransPerfect Trial Interactive Portal to communicate to vendor, submit, and track history of related jobs.
• Maintain up to date on DePuy Synthes compliance training material through Plateau and Learning Center.

SharePoint Designer/Technical Writer -BA

Confidential

• Consultant, Responsible for the Designed and Implemented regulated SGH Inspection Forms in SharePoint InfoPath 2010, to comply with Sikorsky Global Helicopters SGH audits in the Emergency Health Services EHS .
• Ensured inspection forms complied with European Aviation Safety Agency EASA and the Federal Aviation Administration FAA in the U.S and Sikorsky Aircraft and Flight Safety guidelines.

Technical Writer/Compliance Validation Lead

Confidential

• Responsible for ensuring all Project Documentation complies with FDA GxP and / or PDMA regulations.
• Provide templates to teams and advises teams on the necessary content of documents.
• Ensure teams include documentation deliverables in project plans.
• Perform 1st review of all documentation before it goes to compliance management.
• Reconciles requirements entered into Quality Center to requirements contained in documentation.
• Distribute and collect signatures on all documentation.
• Maintain project documentation numbering system.
• Maintain the documentation storage areas electronic and hardcopy Validation Activities Change Request and Project .
• Review validation scripts in Quality Center to ensure the validation creation process is followed and appropriate screen prints are present to confirm activity
• Verify all requirements have an at least one associated validation script.
• Collaborate with teams to reconcile pass/fail validation results within Quality Center and validation documentation.
• Ensure deviations defects are properly entered into Quality Center and are captured on report documentation.
• Ensure deviations defects are properly resolved, and documented.
• Confirm associated screen prints properly display the results from an independent review.
• Ensure all actual results are filled in and conforms the validation step.
• Generate traceability matrices and work with teams to reconcile the data contained within the trace matrices.
• Escalate project or validation issues to Project Lead, or Manager.
• Prepare validation metrics for Lead metrics to be defined .
• Provide Training in HP Quality Center, Documentation and validation to ensure SDLC processes are followed.

Technical writer/SharePoint Admin/Trainer

Confidential

• Leader and SharePoint SME handling the entire SharePoint support for BBCGP, 80 offices in 26 different countries.
• Create SharePoint training instructional documentation for SharePoint developed intranet site.
• Perform work on the intranet, support and train end users while maintaining a highly detailed and organized approach to all work.
• Train end users on how to use SharePoint site, explain technical questions and answers in a lower level way to communicate effectively with non-technical people.
• Host WebEx training five days a week, every two hours open to all participants providing guidance on how to navigate the new organization collaboration website, update personal profile information and learn, share and connect with colleagues across the organization.
• Perform security and administrative tasks associated with developing and maintaining a SharePoint intranet.
• Build custom web parts and pages as well as data migration manual transitions .
• Report daily project updates directly to the Director of IT, obtain direction on the intranet plans.

Computer System Validation III/Technical Writer

Confidential

• Lead CS consultant, Displayed knowledge of thorough understanding of System Development Life Cycles for FDA regulated applications in a GxP compliance environment.
• Developed Computer System Validation deliverables for FDA-regulated applications: Validation Plans, Requirement Specifications, various levels of software validation scripts IQ, OQ, PQ , Traceability Matrix, and Validation Reports.
• Ensured application complies with US CFR 21 Part 11 regulations, or follows US CFR 200, 300, or 800 series.
• Supported UAT with high volume application validated environment.
• Utilized Quality Center automated Software Validation tools to comply with Sarbanes-Oxley SOX regulations. Imported validation plans/requirements into QC using Excel specific format and linked the documents to each other for traceability.
• Attended training through ELearning and Compliance Wire to enhance my knowledge in QA Auditing, as well as Corrective and Preventative Action program.
• Performed exceptional in a project team setting. Attended weekly project meetings, provided updates on CS deliverables to ensure tasks are on target with project deadlines.
• Guided project team through the validation process. Track, schedule, and manage validation issues to ensure commitment dates are met. Jointly develop, communicates plan with project team.
• Insured timely flow of information with project team. Managed Validation Project Plan and change control processes. Responsible for tracking, coordination, and project planning of Computer System Validation activities.

Quality Assurance Lead/Technical writer

Confidential

• Lead Quality Assurance Business Analyst tasks, for the IMS/TSU department. Main responsibility to ensure the developed Application is working as expected in QA and Production environments, Reports display in PDF format through Appligent Append Pro.
• Validated developer's code to ensure code complies with client Code Standards, and Reviewed developer's builds on their development environment to ensure all documents release notes, SQL codes/stored procedures, db objects, RDLs, install instructions, servers, schema, etc. are complete through SQL Server.
• Deploy builds to QA environment for deployment, follow precise install/rollback instructions, Setup and Upload RDLs in SSRS Report Manager , run various SQL scripts when needed for immediate attention.
• Lead QA validation on application frontend and generate client reports in batches to ensure code deployment, created indexes/htmls and RDLs are working as expected.
• Deployed final builds to Prod ensure all install documents instructions are obvious for DBA, e-Dels for Production implementations.
• Provided daily updates to users on application build deployments and URLs changes.
• Provided training/support to business users on new and updated application changes. Created business Magic tickets for production deployments, as well as created and maintained all QA JIRA bug-tracking issues.
• Developed business functional specifications to ensure application development meets business needs.
• Exported deviation issues to validate and ensure business requirements meet expectations.
• Executed JIRA System Admin tasks, setup updated user and group role permissions, add workflows, and project specific configurations.
• Provided training/support to business and team members on JIRA dashboard setups, navigation and creating issues.
• Created and delivered shared searches in JIRA to ensure business and keep team members informed of all project issues.
• Served as a SharePoint admin, provide support to departments, business members, developers on site contents, content management, customization with applications and components, and add on.
• Install web parts configure list, libraries, and pages. Setup user permissions, create assignments, tasks for projects milestones.
• Setup navigation lists for different contents. Publish reports, upload documents for collaboration between departments. Setup versioning for check in and check out with documents.
• Assist developer with code review/ASP.Net, to ensure client specifications were adhered to
• Meet weekly on project status, obtain project meeting minutes, organize, and send out minutes of meeting to business and top most managements for review.
• Assisted offshore departments with problems and resolving JIRA issues on needed basis.