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Technical Writer Resume

Lancaster, PA

PROFILE:

  • Senior Software Validation Engineer
  • 20 years pharmaceutical company experience in software validation, technical writing, document control and training.
  • Graduate studies in the FDA Law, cGCP, cGLP, Computer Software Validation.
  • Significant experience in Manufacturing, Clinical and Preclinical systems

TECHNICAL SKILLS:

  • Adverse Events System
  • ARISg
  • Articulate
  • Ascent Capture
  • Capability Maturity Model Integration
  • Documentum
  • EDMS
  • Enterprise Service Bus
  • Excel
  • EZsubs
  • Gamp 5
  • Global Safety Case Receipt
  • Impact
  • Lotus Notes
  • Mercury Quality Center
  • Confidential Integration Document Architecture
  • Oracle
  • Paint Shop Pro
  • Picasso (Remedy)
  • PowerPoint
  • SharePoint
  • SnagIt
  • SQL*
  • Sybase
  • Visio
  • Windows
  • Word
  • Application Migration Plan
  • Change Control
  • Code Remediation Plan
  • Configuration Management Plan
  • Disaster Recovery Plan
  • Impact (Risk) Analysis
  • Installation Qualification
  • Integration Test Plan/Specifications
  • Integration Test Results
  • Integration Test Summary
  • Operational Qualifications
  • Operations Manual
  • Production Qualification
  • System Design Specifications
  • System Test Plan
  • System Test Summary
  • Traceability Matrix
  • Training Plan
  • UAT Specification
  • UAT Results
  • UAT Summary
  • Validation Plan
  • Validation Summary
  • Account Administration
  • Backup and Restore
  • Change Management
  • Computer System Validation
  • Disaster Recovery
  • Emergency Password Management
  • Logical Security
  • Managing Service Levels
  • Minimum Security Requirements
  • Patch Deployment
  • Physical Security
  • Security Incident Reporting
  • Systems Library Management
  • System Log Management
  • Data Remediation
  • Migration Plan
  • Code Remediation
  • Test Summary

EXPERIENCE:

Technical Writer

Confidential, Lancaster, PA

Responsibilities:

  • Writes Standard Operating Procedures
  • Edits Standard Operating Procedures
  • Trains authors in the use of templates

Consultant

Confidential, Raritan, NJ

Responsibilities:

  • Wrote Qualification (Test) Plans
  • Wrote Qualification (Test) Summaries
  • Wrote Compliance (Project) Summaries
  • Advised the team on compliance issues

Confidential, New York, New York

Technical Writer

Responsibilities:

  • Edited Delivery Handbook
  • Guided Project Managers in the documentation of their applications for project funding from the Program Management Office
  • Wrote process instructions for applications for project funding

Confidential, Rahway, NJ

Technical Writer

Responsibilities:

  • Wrote / edited / managed project wide documentation including
  • Design Specifications Test Execution Summary Test Plan
  • Trace Matrix Validation Summary
  • Reviewed project - wide documentation for gaps in validation execution.
  • Wrote / edited

Confidential

Training Materials Writer

Responsibilities:

  • Adapted to the web PowerPoint training materials
  • Developed an advisory document for the distribution of system documentation (and responsibilities) from a free standing Enterprise Service Bus (ESB) System to the documentation for the various systems using the ESB.

Senior Consultant

Confidential, Raritan, NJ

Responsibilities:

  • Wrote / edited / managed project wide documentation including:
  • Code Remediation Template Data Remediation Template
  • High Level Execution Plan Impact Analysis
  • Migration Plan Template Risk Analysis
  • Test Summary Template Validation Plan
  • Wrote / edited / managed application specific documentation including:
  • Application Migration Plan Change Control Management
  • Code Remediation Data Remediation
  • Coordinated migration schedules among interested parties, i.e., application & technical owners, support & test specialists, database administrators, etc.
  • Confirmed the maintenance of validated states through the migration process employing change control, risk analysis, team reviews and migration signoffs.
  • Controlled all migration documentation.
  • Compiled project-wide meeting minutes.

Validation Engineer

Confidential

Responsibilities:

  • Wrote / edited / reviewed project documentation including:
  • Risk Analysis System Design Requirements
  • System Project Plan System SOP’s
  • Trace Matrix User Requirements Specifications
  • User Test Scripts Validation Plan

Senior Validation Consultant

Confidential, Raritan, NJ

Responsibilities:

  • Wrote/edited SOP’s to ensure Confidential and Confidential & Confidential Operating Companies conformity with requirements of the Sarbanes Oxley Law including:
  • Account Management Backup and Restore
  • Change Management Minimum Security Requirements
  • Logical Security Patch Deployment
  • Password Management System Incident Reporting
  • System Library Management System Log Management
  • Wrote SOP’s to manage the delivery of services from Confidential to the Johnson & Johnson operating companies including:
  • Managing Service Levels SLA Structure Maintenance
  • PSS Catalog Maintenance Standard SLA Maintenance
  • Controlled Auditing Documentation (System Plans, Test Plans, Test Results Work Instructions). Assembled 17 volumes from over 75 e-room folders.
  • Inspected Auditing Documentation for accuracy and completeness.
  • Inspected Server Conversion Documentation for accuracy and completeness.

Senior Validation Consultant

Confidential, Teaneck, NJ

Responsibilities:

  • Wrote / Edited Software Development Life Cycle documents including:
  • Disaster Recovery Plan System Test Plan & Scripts
  • Installation Qualification Operational Qualification
  • Production Qualification System Test Plan & Scripts
  • Test Summaries Training Plan
  • UAT Plan and Scripts Validation Summary
  • Supervised execution of Validation Protocols (IQ OQ, & PQ)
  • Wrote / Edited SOP’s including
  • Backup and Restore Change Management
  • Computer System Validation Disaster Recovery
  • Logical Security Physical Security

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