Milsap (technical writer)

CONTRACT PROJECT EXPERIENCE

ITS January **** to April 2009

Specialized Technical Writer

 Assisted in the re-design of Service Catalog website.

 Updated content in Sharepoint.

 Familiar with ITIL v3 process.

SAP America, Inc. July 2008 to December 2008

Senior Technical Writer

 Reviewed accuracy in existing documentation.

 Updated SDLC business process documentation for Global Marketing CRM upgrade.

 Created web based instruction using Captivate software.

 Able to translate technical data from developers into non-technical specifications.

 Provided moderate testing of new functionality.

Smith International August 2008 to October 2008

Senior Technical Writer/Trainer

 Created training manuals for offshore drilling operations.

 Created story-boards and web-based training modules for both internal and external clients.

 Updated content in Sharepoint.

Nano PV April 2008 to May 2008

Senior Technical Writer

 Created comprehensive Operational Manual from the conversion of six engineering manuals.

 Worked with Taiwanese team (in Taiwan) in translating Mandarin Chinese equipment specs into English.

Bedford, Freeman & Worth Publishing August 2007 to March 2008

Senior QA Technical Writer

 Developed SDLC content documentation and customized training materials for Onyx team.

 Co-created QA process for Onyx team.

 Provided testable requirements for offshore test team.

 Participated in Change Control Board activities to ensure system/functional specifications were met.

 Identified the risks and interface issues from approval to rejection of changes.

 Documented best practices.

 Adhered to Systems Development Life Cycle (SDLC) best practices and FDA standards to enhance the overall quality of products and services throughout the system.

 Worked closely with off shore developers and US business sponsors.

Zeus Scientific Inc. August 2007 to November 2007

Senior Technical Writer/Instructional Design

 Created master document of medical device operational manual.

 Identified gap in product documentation.

 Created supplemental documentation used for training internal staff.

MetLife April 2007 to June 2007

Senior Technical Writer (Peoplesoft)

 Revised technical documentation for Peoplesoft upgrade.

 Assisted in the creation of templates.

 Adhered to Systems Development Life Cycle (SDLC) best practices and standards to enhance the overall quality of products and services throughout the enterprise supply chain process.

 Ability to prioritize and meet aggressive deadlines.

 Created process Visio workflows.

 Team player that worked closely with business users and business sponsors.

Bristol Myers Squibb March 2005 to January 2007

Senior TrackWise Validation Technical Writer/ Trainer

 Developed large scale requirements for TrackWise (CAPA, EHS Actions Tracking, Health Authority Commitment Management, EHS Product Recall and Government Inspections and EHS Compliance and Risk Management) implementations.

 Adhered to Systems Development Life Cycle (SDLC) best practices and FDA standards to enhance the overall quality of products and services throughout the enterprise.

 Conducted training on specific Trackwise implementations.

 Co-designed training program/modules for train the trainer sessions.

 Created training manuals.

 Documented business risk analysis from the regulatory compliance perspective.

 Managed team of three technical writers.

 Created process Visio workflows.

 Created Validation Plans, User Requirements, High Level Requirements, Design Specifications, Master Test Plans, Traceability Matrixes, Training Decs and Validation Summary Reports.

 Worked closely with business users and business sponsors.

 Prioritized various work streams and deliverable dates.

 Performed Gap Analysis and performance assessment of the system for future validation initiative.

 Detailed oriented with excellent follow through.

Senior Supply Chain Validation Technical Writer/Trainer

 Worked with user groups to assess operational and functional requirements through interviews, surveys and focus groups to identify gaps and align corporate initiatives.

 Prepared specifications for system changes and systems testing.

 Delivered presentations to stakeholders to gain awareness and support for program prioritization and implementation.

 Researched the risk of each change and validated the appropriate risk level assigned to the change.

 Developed training materials and conducted logistical planning and scheduling for deployment of training.

 Provided train the trainer support to identified system trainers/business owners.

 Certified trainees to measure their learning progress and evaluated effectiveness in training presentations.

 Developed organizational metrics to baseline and measure success over time in conjunction with stakeholders.

 Established strong and credible relationships with management and employees to successfully build trust, collaboration and integrity.

 Experience and knowledge of principles, practices and policies of organizational design, change management and organizational development.

 Reviewed change requests and monitored the changes to make sure they complied with corporate policies and procedures.

 Experience working in a risk-based regulated environment.

Cordis Inc. August 2004 to November 2004

Remediation Consultant

 Member of a remediation team that assessed, qualified, developed and implemented remediation plan for clinical lab facility.

 Analyzed adequacy, reliability, and compliance of internal control systems.

 Interpreted U.S and international regulations and guidelines.

 Mitigated risks of CAPAs.

 Responsible for remediation of Agilent ChemStation GC, HPLC and UV-Vis equipment within R & D Laboratory.

 Knowledge of cGMP/cGLPs, MDD’s and MDR regulations, computer validation and 21 CFR Part 11 Requirements.

 Experience conducting audits, developing Validation Strategy Documents (VSD), User Requirement Specification (URS), Validation Summary Reports (VSR), Standard Operating Procedures (SOPs), IQ/OQ/PQ Protocols and other SDLC documentation.

 Develop audit presentations, and prepared professional, clear and concise reports of findings.

Bristol Myers Squibb July 2003 to July 2004

SAP Validation Technical Writer

 Developed SDLC documentation for various global SAP implementations.

 Worked with off-shore consulting firm to coordinate US, European and Latin American validation effort.

 Ensured documents met FDA, EC, Mexico Ministry of Health, cGxP, Title 21 CFR Part 11 regulations and compliance.

 Created a large scale RFPs.

 Adhered to Systems Development Life Cycle (SDLC) best practices and standards to enhance the overall quality of products and services throughout the enterprise.

 Worked directly with international Project Managers to adhere to US regulatory policies as well as specific country policies and procedures.

 Interacted with clients on weekly status meetings to ensure project met specified timelines.

 Demonstrated multi-tasking ability and problem-solving skills.

 Provided assistance in closing out deviation and exception reports to successfully conclude the validation effort.

 Created Validation Plans, User Requirements, High Level Requirements, Design Specifications, Master Test Plans, Migration Qualifications, Installation Qualifications, Operational Qualifications, Configuration Specifications, Traceability Matrixes and Validation Summary Reports.

 Created detailed documentation for Biologics, Bar Coding, Disaster Recovery, IM/WM, LIMS, PP-PI, Purchasing and QM Implementations.

 Produced user documentation that described how to use validated equipment, interfaces and software applications.

 Experience working in a risk-based regulated environment.

Abbott Laboratories June 2001 to July 2003

Senior Validation Technical Writer/Trainer

 Delivered Instructor-Led Training on enhanced customized MES System.

 Produced SDLC user documentation on MES and FlowStream systems.

 Co-managed full life cycle documentation deliverables on MES systems.

 FDA and 21 CFR Part 11 regulations and compliance background.

 Instructed classes, with the assistance of support group and/or Help Desk personnel on enhanced MES features.

 Developed curriculum for new applications with the assistance of the designated application support group.

 Developed and updated training materials using non-technical concepts and language for non-IT Professionals to be used in classroom training.

 Developed, promoted and supported the implementation of innovative technology solutions by working closely with program management, application developers, business analysts and infrastructure teams.

 Created protocol-style documents, Standard Operating Procedures (SOP), Traceability Matrixes and Validation Plans.

 Responsible for training Testers on usability testing on validated systems.

 Worked with developers on executing customized test scripts.

 Tested Documentum and LIMS interface applications.

Zurich Insurance October 2000 to April 2001

Senior Technical Writer

 Created North American Command Center Process Operations Manual.

 Used Visio in creation of mission critical/business continuity documentation (Disaster Recovery).

 Assisted in developing project plans, project objectives, implementation timelines, application distribution schedules, scope assumptions and business rules.

 Proven ability to meet project deadlines.

 Designed, developed and implemented web-based training.

 Developed design standards for version control.

 Facilitated data requirements and document review meetings.

 Understanding of Microsoft IIS and Active Server Page development.

 Conducted focus group sessions and coordinated resources within given deadline.

Infosys, Inc. June 1999 to October 2000

Technical Writer/Instructional Design Engineer

 Created User Manual using Word for proprietary medical billing software.

 Updated existing user guidelines.

 Provided training to 115 customers/internal end users on proprietary medical billing software.

 Participated on ASAP & Dynamics implementations and integration testing.

 Performed quality assurance testing of new modules and interfaced daily with programmers.

 Reviewed existing DMS implementations and developed recommendations for problem resolution, enhancement, and tuning.

 Documented new product and revised existing product documentation.

 Designed formative evaluation strategies for user and pilot tests.

 Researched and created content for future training courses.

 Gathered requirements from Finance, HR, Home Health and Patient Account personnel.

 Conducted weekly meetings to cover new scopes/assumptions and or implementation constraints.

EDUCATION

Howard University, 1991 Washington D.C.

PROFESSIONAL ORGANIZATIONS

Society for Technical Communications

HARDWARE, SOFTWARE, FIRMWARE

Operating Systems: Windows XP, Mac OS X, Sun/Solaris, MES, SAP, TrackWise

Word Processors/Layout: Word, WordPerfect, Framemaker, Visio, Snagit, MS Project

On-Line/Web: RoboHelp, Front Page, Adobe Acrobat, WebEx

Graphics: Adobe In Design, PhotoShop, Illustrator, Corel Draw, Publisher, Quark Express, Micrografx Designer, Illustrator, Paintshop Pro 7

Web Communication: Netscape, Internet Explorer, Lotus Notes Learning Space, MS Outlook

Database: Access, Oracle, Documentum, PW Toolkit, Remedy, Onyx CRM

Presentation: PowerPoint

Development Environments: Lotus Notes, HTML, Mozart, Java, Fireworks

Languages: VB, SQL, PL/SQL, HTML, XML

Contact this candidate