RESUME:JOHN HOOK, MCP and Senior Technical Writer

RESUME:JOHN HOOK, MCP and Senior Technical Writer

Address:4522 West Village Drive #148, Tampa, FL 33624Telephone: (813) 928-1440

Email:nline Resume:

OBJECTIVE

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

PERSONAL INFORMATION

Author of Conversion Factors for Scientists, Engineers and Students (Prentice Hall)
HTML Writers Guild—Mac/Windows DeskTop Publisher (DTP)—Microsoft Certified Partner (MCP)
Senior Member: Instrument Society of America (ISA) and ISA General Board of Review
ISA Aerospace Industries Division and ISA Scientific Instrumentation and Research Division
Member: American Institute of Aeronautics and Astronautics (AIAA)
Technical Writer/Editor—Website Developer—ISO 9000 Consultant—Engineer—Trainer—Author

SUMMARY

Experienced; adaptable, communicator, creative, organizer, punctual, socializer, team player and thinker. Experience includes over twenty-five years as a consultant in the engineering, maintenance, manufacturing, operations, and R&D environments. Work experience includes; disaster recovery, software development and testing, computer hardware, integrated circuit, Internet, electric, electronic, mechanical, process improvement, standards, systems and websites. Experienced in 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.Aerospace, insurance, manufacturing, government, nuclear, pharmaceutical, refinery, utility, educational institution, commercial and industrial positions worked as a contractor and employee.

COMPUTER SKILLS

Microsoft DOS, Windows 1.0-3.1, 95, NT, 98, 2000, XP Pro, Vista, 7, 8 and 10,Apple OS X, Parallels Desktop, VMware Fusion, Microsoft Office 365 and 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, SharePoint, SourceSafe, 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 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, SnagIt, Thumbs Plus, Norton Utilities, Rational Rose, Crystal Reports, DEVONagent Pro, 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 on 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 very difficult situations

ACHIEVEMENTS

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

HISTORY:

PROJECTABC Project (Telecommute), ABC, YY (11/14-07/15)

TITLESENIOR TECHNICAL WRITER

TASKInterfaced with management, stakeholders and Subject Matter Experts (SMEs) in developing controlled, reviewed and approved documents to support Building Management Systems (BMS) and Heating, Ventilation and Air Conditioning Systems (HVAC), calibration, functional operability testing, installation, instrument and loop setpoint calculations, maintenance, and repair, etc. Complied with Code of Federal Regulations (CFR) Chapter 21, Part 11, 11.10 Controls for Closed Systems and Chapter 21, Part 211, 211.68 Automatic, Mechanical, and Electronic Equipment.

PROJECTABC Project (Telecommute), ABC, YY (11/14-07/15)

TITLESENIOR TECHNICAL WRITER

PROJECTABC Project (Telecommute), ABC, YY (11/14-07/15)

TITLESENIOR TECHNICAL WRITER

PROJECTJohnsonControls Compliance Documentation and Implementation Project(Telecommute), Glendale, WI (07/13-11/14)

TITLESENIOR TECHNICAL WRITER

TASKInterfaced with management, stakeholders and Subject Matter Experts (SMEs) in developingcontrolled, reviewed and approved documents to support Building Management Systems (BMS) and Heating, Ventilation and Air Conditioning Systems (HVAC), calibration, functional operability testing, installation, instrumentand loop setpoint calculations, maintenance, and repair, etc. Complied with Code of Federal Regulations (CFR) Chapter 21, Part 11, 11.10 Controls for Closed Systems and Chapter 21, Part 211, 211.68 Automatic, Mechanical, and Electronic Equipment.

PROJECTHealth Management Associates (HMA), Centers for Medicare & Medicaid Services(CMS) Compliance and Implementation Project, Naples, FL (01/13-05/13)

TITLESENIOR TECHNICAL WRITER

TASKDeveloped documents to comply with and implement CMS requirements including, but not limited to; Affordable Care Act of 2010 (ACA), Distaster Recovery, Information Security, Evaluation and Management Services, General Principles of Medical Record Examinations, History of Present Illness, Review of Symtoms, 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.

PROJECTMicro Matic (Bar and Restaurant Beer Systems and Closed Loop Chemical Systems), ISO 9000:2008 Registration Project (Telecommute), Brooksville, FL (03/12-10/12)

TITLESENIOR TECHNICAL WRITER

TASKWorked 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.

PROJECTVoalté(Voalté One Hospital Communications System Class III Medical Device), 510(k) Premarket Notification Submission (Telecommute), Sarasota, FL (06/11-11/11)

TITLESENIOR TECHNICAL WRITER

TASKInterfaced 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.

PROJECTFlorikan Continental Rollo-Mixer Mark IX Operations and Maintenance Manual, Quality Assurance Manual and Miscellaneous Documents Project, Sarasota, FL (12/10-06/11)

TITLESENIOR TECHNICAL WRITER

TASKWorked 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.

PROJECTGlobal Safety First ReadiMask, National Institutes of Safety and Health (NIOSH) N95 Particulate Respirator Certification (Telecommute), Manasquan, NJ (02/10-08/10)

TITLESENIOR TECHNICAL WRITER

TASKWorked 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.

PROJECTUnited Information Technologies (UIT), FairPoint Project, Tampa, FL (12/08-10/09)

TITLECOPY EDITOR/SENIOR TECHNICAL WRITER

TASKWorked 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.

PROJECTAES Corporation(A Global Electrical Energy Distributor and Generator), World Headquarters, SAP Global Rollout Project, Arlington, VA (09/07-03/08)

TITLESENIOR TECHNICAL WRITER

TASKDeveloped 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.

PROJECTAstraZeneca-MedImmune (BioPharma, Pharmaceuticals and Medical Devices), World Headquarters, SAP Computer Validation Group, Gaithersburg, MD (04/06-09/07)

TITLESENIOR TECHNICAL WRITING CONSULTANT

TASKDeveloped, 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) documents; Project Scope and Development Plans, User Requirements Specifications (URS) and Functional Requirements Specifications (FRS), etc.

PROJECTWyeth (Pharmaceuticals), Worldwide Headquarters, Policies Upgrade Project (Telecommute), Collegeville, PA (02/05-08/05)

TITLETECHNICAL CONSULTANT (direct contract with Wyeth corporate management)

TASKDeveloped 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.

PROJECTBoston Scientific Electrophysiology Division (Medical Devices), Manufacturing Documentation Project, San Jose, CA (03/05-07/05)

TITLESENIOR TECHNICAL WRITER

TASKAssisted 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.

PROJECTBristol-Myers Squibb (Pharmaceuticals), Global Shared Services, Information Security and Service Assurance-Quality Assurance, Princeton, NJ (09/04-01/05)

TITLESENIOR TECHNICAL WRITER/EDITOR

TASKAssisted 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.

PROJECTPfizer Global Research and Development (PGRD) (Pharmaceuticals), FDA Validated Computer System Migrations, Groton, CT (01/04-06/04)

TITLESENIOR TECHNICAL WRITER

TASKAssisted 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.

PROJECTRoche Diagnostics Corporation (Medical Devices and Pharmaceuticals), Single Strip System Glucose Meter, Huntsville, AL and Indianapolis, IN (06/03-01/04)

TITLESENIOR TECHNICAL WRITER

TASKAssisted in the development of the rack and test-fixture Automated Test Equipment (ATE) calibration system for the Roche Single Strip System Glucose Meter. Developed all system and component-level project specifications. Developed templates, procedures and design documents including Database Structure, Hardware and Software Requirements Specifications, Mechanical and Electrical, and Unit and Integration Tests, etc., to comply with 21 CFR Part 11 requirements, etc.

PROJECTEli Lilly and Company (Pharmaceuticals), K103 Parenteral Manufacturing Facility Startup and Parenteral Health and Safety Programs, Indianapolis, IN (09/01-03/03)

TITLESENIOR TECHNICAL WRITER

TASKDesigned and developed operations and maintenance procedure templates and procedures, such as; CIP, SIP, Data Historian, Equipment Systems and Utilities Validation, Formulation, Filling, Freeze Drying, Parts Washer, PUAF Unit and SCADA Operations etc., to support the startup of the K103 Parenteral Manufacturing Facility and comply with 21 CFR Part 11 and cGMP requirements. Designed and developed the Parenteral Health and Safety Program Plan Template and Programs, such as; Contractor Safety, Hazards Communication, LOTO and Lone Operator, etc.

PROJECTSpartan Electronics, (Contract Electronics Manufacturer (CEM)) Equipment and Facilities Operations Project, Brooksville, FL (05/01-09/01)

TITLESENIOR TECHNICAL WRITER

TASKPerformed interviews and research, and subsequently developed procedures to implement Just In Time (JIT), Kanban and Lean Manufacturing practices. Met with and interviewed executive, management, engineering, operations, maintenance and production personnel. Determined the appropriate basis standards and wrote and/or edited standards and procedures to implement the program plan.

PROJECTMeister Electronics (CEM), Mass Transit Systems Division, Bombardier-Hiawatha Project, Tampa, FL (03/01-05/01)

TITLECOMPLIANCE ENGINEER

TASKDetermined analyzed and ensured compliance of components, equipment, materials and products with contract requirements. Made Failure Modes and Effects Analysis (FMEA) and Mean Time Between Failure (MTBF) calculations and provided documentation to support compliance with contract requirements. Met with Meister Electronics management and engineering personnel and teleconferenced with Bombardier management and engineering personnel. Wrote the Reliability Availability Maintainability and Safety (RAMS) Program Plan and other supporting documents.

PROJECTBayer Pharmaceuticals Plasma Fractionation Products Facility, Facility Engineering Standards Policy and Program Plan, Clayton, NC (09/00-12/00)

TITLESENIOR TECHNICAL WRITING CONSULTANT

TASKDetermined the requirements for, then designed, tested and implemented, the Facility Engineering Standards Policy and Program Plan. Determined the appropriate basis standards and wrote and/or edited standards and procedures to implement the program plan. Consulted with executive and senior management as needed to develop and implement the program plan, including the logistic and operational infrastructure.

PROJECTCity, County and State Department of Public Safety, Combined Emergency Operations Center, Austin, TX (05/00-8/00)

TITLESYSTEMS INTEGRATION ENGINEER

TASKDeveloped and maintained the program level master plan and schedule. Developed and implemented the program level document management plan, including the support infrastructure. Developed and implemented the program level risk management plan, including the support infrastructure. Assisted in the development of the emergency operations center layout with city, county and state management personnel and the architect. Advised client on infrastructure design, network architecture and planning.

PROJECTCustomer Service Website-United States Automobile Association (USAA), (Insurance Company), San Antonio, TX (06/99-10/99)

TITLESENIOR TECHNICAL WRITERAND WEB DEVELOPER

TASKDeveloped customer service Internet website e-commerce materials and templates. Produced materials for software coding standards and wrote said standards to meet the homogenized client, American National Standards Institute (ANSI), Institute of Electrical and Electronics Engineers (IEEE), International Standards Organization (ISO) and Software Engineering Institute (SEI), Capability Maturity Model (CMM), Level II software requirements. Developed customer service, release two user guides, etc., for use by 40 infrastructure and software developers and software test personnel on the website.

PROJECTBaxter Healthcare Renal Products (Medical Devices), Division, Meridian Project, Largo, FL (11/97-09/98)

TITLESENIOR ENGINEER AND TECHNICAL WRITER

TASKEngineered the Research and Development (R&D), department documentation system to support and minimize audit findings in the Design History File (DHF), in preparation for the 510(k) Submission to the Food and Drug Administration (FDA). Participated in the R&D of medical devices from the perspective of FDA compliance requirements. Advised client management on a daily basis. Developed various systems and support documentation including the Project Plan (PP), Product Launch Plan (PLP), Product Requirements Document (PRD) and Software Requirements Specification (SRS), etc.