OBJECTIVE

Assist organizations with technical writing, web development, engineering and/or quality challenges.

SUMMARY

My experience includes over twenty-five years as a consultant in the engineering, maintenance, manufacturing, operations, and R D environments including computer hardware, disaster recovery, integrated circuit, Internet, electronic and mechanical components, software development and testing, standards, systems and websites. I also have experience with 21 CFR Part 11, ANS, ANSI, ASME, CAPA, CFR, cGMP, CMM, CMS, DOD, DOE, FDA, GXP, HTML, IEEE, INPO, ISA, ISO, LOTO, MIL, NIST, NQA-1, NRC, QSR, SAP, SDLC and SEI requirements, etc. I am an experienced technical writer/editor, website developer, ISO 9000 specialist, engineer, trainer and author. I have worked aerospace, commercial, educational institution, government, industrial, insurance, manufacturing, nuclear, pharmaceutical, refinery and utility positions as both a contractor and employee.

COMPUTER SKILLS

Microsoft DOS, Windows 1.0-3.1, 95, NT, 98, 2000, XP Pro, Vista, 7 and 8, Apple OS X, Parallels Desktop, VMware Fusion, Microsoft Office Suite Word, Excel, PowerPoint, Access, Outlook, PhotoDraw and Publisher , UNIX, SAP ERP, HR, MM and SD Modules, HP/Mercury Quality Center, HP/Mercury QuickTest Pro, Citrix Systems EDMS, Documentum, Livelink, PVCS, SourceSafe, Sparta Systems TrackWise, Visual SourceSafe, Mettler FormWeigh.Net, Microsoft Internet Explorer, FrontPage, Expression Web NetMeeting, HotDog Pro, HotMetal Pro, Active Server Pages ASPs , CGI, JavaDoc, JavaScript, Microsoft Office 365, Project, SharePoint and Visio, WordPerfect Office Suite, Apache OpenOffice Suite, Google Docs, Lotus Notes, FreeHand, Illustrator, PaintShop Pro, Pixelmator, Adobe Acrobat Pro, Captivate, Dreamweaver, Fireworks, Flash, FrameMaker, Illustrator, InDesign and Photoshop, ClipMate, FullShot, SnagIt, Thumbs Plus, Norton Utilities, Rational Rose, Crystal Reports, DataGrabber, Inforarian Quest, Mata Hari, and Research Pro, etc.

ABILITIES

• Ability to draw on vast experiences to produce cost-effective, quality solutions for client needs
• Ability to operate a wide variety of computer platforms using a broad spectrum of software
• Ability to successfully design and implement various types of documentation and systems
• Ability to supervise personnel and get along very well with others, even in difficult situations

ACHIEVEMENTS

• Completed various contracts with some of the most prestigious organizations in this country
• Developed the standardized template for the preparation of various Ely Lilly procedures
• DOE Conduct of Operations CONOPS , Outstanding National Achievement Award
• DOE Significant Achievement Award for Annunciator Response Procedures ARPs

HISTORY:

PROJECT Health Management Associates HMA , Centers for Medicare Medicaid Services CMS Compliance and Implementation Project, Naples, FL 02/13-08/13

Confidential

Developed documents to comply with and implement CMS requirements including, but not limited to Affordable Care Act of 2010 ACA , Disaster Recovery, Information Security, Evaluation and Management Services, General Principles of Medical Record Examinations, History of Present Illness, Review of Symptoms, Medical Record Documentation, Past, Family, and/or Social Histories, Documentation of Examinations, General Multisystem Examination, Multiple Organ System Examination, Single Organ System Examination, Content and Documentation Requirements, etc.

Confidential

Worked with the engineers and management to develop the Micro Matic Quality Assurance Manual and the six 6 required procedures Document Control, Clause 4.2.3, Record Control, Clause 4.2.4, Internal Audit, Clause 8.2.2, Control of Nonconforming Items, Clause 8.3, Corrective Action, Clause 8.5.2, Preventive Action, Clause 8.5.3 for ISO 9000:2008 registration. Developed the Procedure Preparation, Review and Approval Procedure and a template to aid Subject Matter Experts SMEs and other stakeholders in preparing procedures. Developed other documents needed to implement and support the Micro Matic Quality Management System QMS . Found, made initial contacts with and interviewed five ISO 9001 registrars for the client.

Confidential

Interfaced with management and engineers as needed to develop the documents required by the Food and Drug Administration FDA for a Premarket Notification 510 k including Indications for Use, Product Description, Predicate Product Comparison, Labeling, Sterilization and Packaging Information, Biocompatibility, Level of Concern, Software Description, Device Hazard Analysis, Software Requirements Specification SRS , Architecture Design Chart, Software Design Specification, Traceability Analysis, Software Development Environment, Verification and Validation, Revision History, Unresolved Anomalies, Human Factors Study, Software of Unknown Pedigree SOUP , Virus Protection Software, Interfaces and Network Infrastructure Products, etc.

Confidential

TITLE SENIOR TECHNICAL WRITER

TASK Worked with the engineers, maintenance and operations personnel to develop the Continental Rollo-Mixer Mark IX Operations Manual including the following procedures Raw Materials Filling, Coating Heating, Coating, Dump, Basic Maintenance and Troubleshooting Tips and Lockout/Tagout LOTO . Worked with engineers to develop the QMS including the Florikan Quality Assurance Manual and the six 6 required procedures Document Control, Clause 4.2.3, Record Control, Clause 4.2.4, Internal Audit, Clause 8.2.2, Control of Nonconforming Items, Clause 8.3, Corrective Action, Clause 8.5.2, Preventive Action, Clause 8.5.3 for ISO 9000:2008 registration. Developed the Procedure Preparation, Review and Approval Procedure and template.

Confidential

TITLE SENIOR TECHNICAL WRITER

TASK Worked with management and regulators to resolve the originally in-house developed rejected certification application by addressing concerns and findings with best practices. Developed the company organizational flowchart. Wrote the Quality Assurance Manual to comply with and satisfy NIOSH requirements including the Procedure for the Certification of Respirators and the required Title 42 Public Health, CFR, Subpart E Q, Sections 84.40, 84.41, 84.42 and 84.43.

Confidential

TITLE COPY EDITOR/SENIOR TECHNICAL WRITER

TASK Worked with FairPoint developers and UIT contractors to build, convert and edit flowcharts, handouts, job aids, PowerPoint presentations, procedures, scripts and tests used by customer service, engineers, installers, management and operators etc. All documentation was reviewed for compliance with FCC regulations by FCC contractors. Resolved and incorporated comments on a near real-time basis. Documents were then reverified, approved for publication and delivered to the client. Scheduled and delivered the training and provided feedback to Fairpoint and UIT, etc.

Confidential

TITLE SENIOR TECHNICAL WRITER

TASK Developed various SAP global template documents for corporate and North American operations. Developed materials for SAP blueprint sessions and playbacks. Developed, edited and executed SAP test scripts. Developed Business Process Documents BPDs and the associated master swimlane flowcharts to implement the processes defined in the BPDs. Developed Global Position Papers . Played a management advisory roll, etc.

Confidential

TITLE SENIOR TECHNICAL WRITING CONSULTANT

TASK Developed, edited, and ran SAP test scripts manually and via HP/Mercury Quality Center. Reviewed and approved executed SAP test scripts. Used HP/Mercury QuickTest Pro and Test Director to help develop automated test scripts. Developed and maintained hundreds of Master Flowcharts to implement Software Development Life Cycle SDLC documentation including Project Scope and Development Plans, User Requirements Specifications URS , Functional Requirements Specifications FRS , etc.

Confidential

TITLE TECHNICAL CONSULTANT direct contract with Wyeth corporate management

TASK Developed the Wyeth Worldwide Environmental Health and Safety EHS Policies Manual, and the Wyeth Corporate EHS Policy, for Robert Essner, President and Chief Executive Officer CEO , including Management Systems, Accident Investigation, Regulatory Inspections, Safe Work Practices, Capital Projects, Operational Readiness Reviews ORRs , Personnel Protective Equipment PPE , Ergonomics, Process Safety Management PSM , Contractor Management, Lab Safety, Change Management, Machine Guarding, Hazard Communication, Respiratory Protection Program RPP , Hazardous Substances, Confined Space Entry and LOTO, etc.

Confidential

TITLE SENIOR TECHNICAL WRITER

TASK Assisted production supervisors, engineers and managers with the preparation of Master Validation Plans MVPs , Manufacturing Process Instructions MPIs , Work Instructions WIs , Validation Protocols, databases and spreadsheets for various product lines including Blazer II Cardiac Ablation Catheters, Chilli Cooled Ablation Catheters, Explorer Fixed Curve and Rotational Diagnostic Catheters, Polaris Steerable Diagnostic Catheters and RPM Realtime Position Management Catheters, to comply with the appropriate FDA requirements including 21 CFR Part 11, etc.

Confidential

TITLE SENIOR TECHNICAL WRITER/EDITOR

TASK Assisted analysts, architects, developers, engineers and managers with 21 CFR Part 11 and Sarbanes-Oxley Act SOX requirements compliance for validated computer systems, and validated manufacturing systems, etc. Developed and used templates, procedures and SDLC documents including Basis of Estimates, Scopes of Work, Project Plans, Design Documents, Software and Hardware Specifications, Test Scripts, Project Summary Reports and Records Retention Requirements, etc.

Confidential

TITLE SENIOR TECHNICAL WRITER

TASK Assisted management, architects and developers in the migration of FDA validated computer systems. Developed and used templates, procedures and SDLC documents including Basis of Estimate, Scope of Work, Project Plans, Design Documents, Software and Hardware Specifications, Test Scripts and Project Summary Reports etc., to comply with SAIC, PGRD and 21 CFR Part 11 requirements, etc.