Technical Documentation Management
Resume:
LAVONNE PROWKER
Phone: Cell# 704-***-****
********@*****.***
EXECUTIVE SUMMARY
Development and Administration of Product Data Management and Document Control Systems
Administrator/Coordinator of Network training and system documentation of all Documentation Control and MRP/ERP/PDM system Policies and Procedures
Computer proficient in AS400, SAP, MRP, ERP, Microsoft Office, Word, Excel, Power Point, Visio, Lotus Notes, LiveLink, PageMaker, FrameMaker, Visual Basic, Adobe Acrobat, SnagIt, Data Entry Emulator, UDMS, Documentum, SharePoint, Meridian Enterprise Data Management. MS Office Visio schematics illustrations documentation
Development, Organization and Editing of Technical Documentation, Publications Documentation and Documentation Life-Cycle Processing (SDLC, iQMS, iSLC) including (SOP’s, PM's, LOTO's, ECO’s, BOM’s, CAPA, Deviations, Change Control, Batch Records, DHR’s, Training documents, Engineering specifications documentation. Detailing system architecture illustrations.
Business Analysis and Project Documentation Management of IT requirements, workflow procedures, design and specification
Safety Policies and Procedures, 21 CFR Parts 210 / 211, 600 / 601 / 610 and 21 CFR Part 11 Electronic Records / Signatures utilizing IQ, OQ, PQ) for Quality and Regulatory compliance with ISO 9000, cGMP, FDA, OSHA and DOT regulations.
Data information reporting utilizing extensive MS Excel, pivot tables, vlookup and VB script data extraction tools for accurate project reporting.
Document IT interface software and hardware capabilities and requirements for new Architecture from HP Maximo integrations to Cisco BMC Remedy document IT interface software and hardware capabilities and requirements for new Architecture utilizing ITIL process and procedures
Project Coordination and Management of project activities including: project performance, resource allocation and status. Ability to receive data from multiple sources and convert into technical documentation. Develop and ensure good communication and business relationships.
PROFESSIONAL EXPERIENCE/ACCOMPLISHMENTS
Project Specialist – Herbalife Winston-Salem NC: 03/15 - present
Project Specialist - Randstad Technologies @ Herbalife Winston-Salem, NC: 10/14 – 03/15 converted to Perm
Assist various departments with requests to revise existing products in a cross-functional environment
Analyze Product Revision Requests (PRR) and gather all necessary information and
Analyze change requests prior to routing for approvals and initiate projects.
Continually create and manage Projects by identifying project dependencies and critical paths
Identify risks associated with project changes such as regulatory timing and sales fluctuations and escalate risks to cross-functional teams as needed.
Build rapport and gain commitment from key cross-functional global team members to ensure tasks are completed.
Drive projects through all stages of development from concept to availability at local distribution centers.
Track the flow of SKU changes and assist in problem solving by developing satisfying solutions.
Manage all product revision requests and projects to ensure business processes are maintained and priorities are met.
Create projects in Agile, attend/organize meetings, and streamline activities with other departments to complete the product revision project in a timely manner
Technical Writer/Business Analyst, ITSM Project -TEKsystems @ Bank of America, Charlotte, NC: 04/14 – 03/15
Create and document IT interface software and hardware capabilities and requirements for new Architecture From HP Maximo integrations to Cisco BMC Remedy.
Working with team of Data, Business and Solution Architects to gather and understand technical information in order to document Process, Procedures and Integrations Data Mapping for development, deployment, workflow procedures, design specifications and installation instructions for internal and external end users
Literature and publication documentation utilizing ITIL processes and procedures
Data information reporting utilizing extensive MS Excel, pivot tables, vlookup and VB script data extraction tools for accurate project reporting.
Planning of project deliverables, including timeline, charting and presentations for Incident Management and Problem Management integration section of project.
Product Documentation Specialist Lead – Hayward Industries, Pool Division, Clemmons, NC: 03/05 – 01/14
Create and monitor all Product Information and Documentation relative to new or existing products, components, systems and sub-systems produced or sourced. Including Bills of Material (BOM), Item Master, Product Change Documents (ECR, NPR, NSR, OBS and QCR) and Quality Inspection First Articles (FA’s). Work cross-functionally while ensuring that the highest level of accuracy, quality and integrity of product information data is achieved and maintained with strict adherence to all company policies and procedures.
Business Analysis and Project Documentation Management of IT requirements for new Product Change Documentation Approval and Product Document Management System databases to accurately document all Product Changes including, drawings, IM, BOM’s, Literature and publication documentation activities, utilizing FrameMaker.
Data information reporting utilizing extensive MS Excel, pivot tables, vlookup and VB script data extraction tools for accurate project reporting.
Administrator/Coordinator of Network training and system documentation of all Documentation Control and MRP/ERP system Policies and Procedures. Excellent knowledge of the MRP/ERP/PDM business system field and logic structure as it pertains to Documentation
Coordinate with Engineering Management, Plant Engineering, Marketing, Sales, Quality, IT and Manufacturing to ensure implementation of new products and changes to existing products are consistent with new product development plans, Bill of Materials (BOM), Product Change Documentation, First Articles (FA) and Cost Reduction/Standardization plans.
Lead all Bill of Material activity by working with engineers and designers during the development and revision of product components, sub assemblies and Finished Goods.
Lead and Monitor all Product Change Documentation activity, Product Data Management database for engineering drawing changes, releases, revision levels, effective dates and approval status.
Assist in the Creation and maintenance of Time Capture Database for time reporting of project related activities. Including labor hours, expense through PO, Sample request, Tooling, and administrative activities.
Provide technical support to manufacturing for the resolution of manufacturing issues associated with components, systems, subsystems or products.
Provide detailed IT documentation requirements for new Project expense database and Time reporting database utilizing, FrameMaker, Masterpiece, AS400 and Lotus notes. Create project documentation of IT requirements, workflow procedures, design and specification
Writing of Sequel reports utilizing the AS400 data management and knowledge of the AS400 system for database information withdrawal.
Work with IT to enhance new screens for information retrieval in order to streamline company process for planning, engineering, manufacturing, technical service and sales.
Development, Organization and Editing of Technical Documentation, Publications Documentation and Documentation Life-Cycle Processing (SDLC, iQMS, iSLC) including (SOP’s, PM's, LOTO's, ECO’s, BOM’s, CAPA, Deviations, Change Control, Batch Records, DHR’s, Training documents, Engineering specifications documentation. Detailing system architecture illustrations.
Technical Writer /BA/ Project Coordinator - PGRD Global Identity Services – Pfizer Inc, New London, CT: 06/04 – 03/05
Project Coordination of project activities including: project performance tracking, resource allocation and project status while developing and ensuring good communication and business relationships with internal and external customers. Maintain project deliverable dates - operational calendar, assist PM in planning, action items and deadlines of all deliverables. Conduct weekly status meetings; communicate team status and issues to management and/or project leads.
Develop, implement or acquire standards, guidelines, processes, templates, workflows and other tools to facilitate production of consistent departmental documentation.
Technical Writing, Template Format and Editor of Technical Documentation by researching and interviewing of (SME) Subject Matter Experts, internally and externally to compile information for development of Informatics System Life Cycle (iSLC) documents: Technical and Functional Requirements Specifications, Deployment and Delivery Plans, Architecture Scope Document, Communications Plan, Program Plan, Project Plan, Project Schedule, Architecture Initiation Review, Deliverables Signature Matrix, Risks and Issues Log, Design Specifications (Process Maps / Models), Traceability Matrix, Training Development / Workbooks and Delivery Plan, Application Dependency, Source and Target Physical Data Directory, Transformation Map, Compliance Report, Test Case Index and Details, Support Data Elements, Production Change Control, Production Deployment Plan, Server, Client and Qualification Installation Procedures, Lessons Learned Report, System and Technical Disaster Recovery Plans, System Integration Plan, Calibration, CIT and Security SOP’s, Regulatory Compliance, Users Manuals, Instructional documents and Training Materials for compliance with 21 CFR Parts 11, ISO, cGMP, NIH, EMEA and FDA.
Power Point and Visio training presentations for Global Identity Services (GIS) Executive Briefing and Program summary for Secure Access for Everyone (SAFE) legally binding digital signatures. GIS to deliver digital signature capabilities to all regulatory, legal and financial transactions thus allowing elimination of hybrid systems and the need for paper and wet transactions and remote access for internal and 3rd parties using production integrated badge and Microsoft credential. Secure e-mail (digitally signed and encrypted messages).
Development, Organization and Editing of Technical Documentation, Publications Documentation and Documentation Life-Cycle Processing (SDLC, iQMS, iSLC) including (SOP’s, PM's, LOTO's, ECO’s, BOM’s, CAPA, Deviations, Change Control, Batch Records, DHR’s, Training documents, Engineering specifications documentation. Detailing system architecture illustrations.
Create project documentation of IT requirements, workflow procedures, design and specification
Technical Writer /BA/Engineering Compliance – Wyeth Vaccines, Sanford, N.C.: 09/03 – 05/04 (Contract)
Technical Record Writing, Trainer, Template Format and Editor of Technical Documentation (Lockout/Tagout Procedures, Preventive Maintenance Procedures, Security Standard Operating Procedures, Regulatory Compliance documents, Training documents / Workbooks, Engineering specifications, Calibration procedures, Safety Policies and Procedures, and Project Narratives).
Research and interview (SME) Subject Matter Experts, internally and externally to Compile information for development of Technical Documentation.
Documentation Life-Cycle Process for compliance with ISO, cGMP, OSHA and FDA.
QA/RA Documentation Coordinator/Technical Records Analyst – Siemens Medical, Charlotte, N.C.: 07/93 – 02/99
Development and Maintenance of the Complaints (CAPA), Deviation Investigations, Engineering Change Control Systems.
Compliance Training Coordinator for Quality Assurance / Regulatory Assurance Regulations.
Project Management of New Releases, Obsolescence and Documentation Life-Cycle Processing.
Develop, implement or standards, guidelines, processes, templates, workflows to facilitate production of consistent documentation.
Manage documentation through lifecycle: approval of initial request, work assignment, review and approval of documentation, communication and maintenance plans, time and resource estimates.
Maintenance of Regulatory Documentation Database.
Documentation Development and Organization of (Standard Operating Procedures, Labeling, Operation Instruction Manuals and Training Workbooks for Publications, BOM's, prints and databases) for Quality and Regulatory compliance with ISO, cGMP and FDA regulations.
Certified Auditor for ISO / cGMP Internal and External inspections.
Documentation Manager – Fycon Technologies, Charlotte, N.C.: 09/90 – 07/93
New Facility (Startup)- Development and Organization of the Documentation Department and Engineering Change Control Systems of (Standard Operating Procedures, Labeling, Operation and Instruction Manuals, BOM’s, prints and databases.
Documentation Training Coordinator.
Develop, implement or acquire standards, guidelines, processes, templates, workflows and other tools to facilitate production of consistent departmental documentation.
Manage documentation through lifecycle: approval of initial request, work assignment, review and approval of documentation, communication and maintenance plans, time and resource estimates.
Project Management of New Releases and Obsolescence.
Documentation / Business Records Analyst Manager – ESM, Charlotte, N.C.: 10/83 – 09/90
Department Supervisor for Electronic Cabling and Documentation Manager.
New Facility (Startup) - Development and Organization of Documentation Department (Standard Operating Procedures, Labeling, Operation and Instruction Manuals, BOM’s, prints and databases).
Develop, implement or acquire standards, guidelines, processes, templates, workflows and other tools to facilitate production of consistent departmental documentation.
SPECIAL TRAINING:
AS400 Sequel training
MS Office training in Excel and Power Point for Data information reporting MS Excel, pivot tables, vlookup and VB script data extraction tools for accurate project reporting
MRP/ERP information withdrawal training utilizing UDMS
Trained for Blood borne Pathogens, Lab Hazard Communication and Safe Work Practices.
Certified Auditor for ISO / cGxP Internal and External inspections.
21 CFR Part 11 Electronic Records; Electronic Signatures
21 CFR Parts 210 & 211 cGMP in Manufacturing, Processing, Packing or Holding of Drugs and Finished Pharmaceuticals
21 CFR Part 600 Biological Products, Part 601 Licensing and Part 610 General Biological Products Standards
21 CFR Part 820 Good Manufacturing Practice (Compliance) For Medical Devices / Quality Systems Regulations
PDM InnoCielo Meridian database Administrator
Education: CPCC –Computer Science/Programming
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