SUMMARY:

• Professional Technical Writer with extensive experience working in the laboratory, manufacturing, etc. environment. Responsible for communicating with all departments for proper documentation and creating SOPs' and workflows following GMP Best Practices for process improvement. Expertise in Document Management Systems such as Tiger, LeGrand, Micro Strategies, Master Control, etc. Additional skills include, multi - task capabilities, conflict resolution and project planning/tracking along with exceptional oral and written communication skills. Available for an interview with 24 hours of prior notice and can start within 2 weeks.

PROFESSIONAL EXPERIENCE:

Confidential, Summit NJ

Technical Writer/Editor

Responsibilities:

• Draft, revise, review route and approve Process improvement Standard Operating Procedures, Work Practices, Forms, and other GMP documentation deliverables
• Responsible for routing document deliverables through the Document Management system (Sharepoint, Veeva Vault).
• Assist with writing deviations, CAPAs, Change Controls, Protocol Forms
• Facilitate periodic reviews of SOPs and provide subject matter expertise in documentation best practices
• Responsible for assisting and facilitating in requirement gathering, documenting efficient procedural solutions to varied and complex challenges
• Attend and participate in meetings and discussions to define and capture procedures and procedural changes
• Capture meeting notes and tasks and ensure timely distribution.
• Keep a log of documents and their states, including types, owner, reviewers, due dates, etc.
• Follows up with team members and cross functional team members to encourage timely review and approval
• Current Projects: Updating Validation Templates inlcuding Configuration Specifications, IQ/OQ/PQ/UAT, Validation Summary Report.
• Updating SOP's including Disaster Recovery, Emergency Change (through Change Control), Naming Convention for Document Managment System Documents.

Confidential, Pine Brook, NJ

Tech Writer/Editor

Responsibilities:

• Create SOPs' and Workflows following GMP Best Practices for Process Improvement, Gather Requirements
• MS Word, Google Docs and Sheets, Document 360
• Communicate with All Departments for Proper Documentation
• Document Accessioning of cases for Triage using Tiger Web Based software
• Document Creation of Blood and Bone Marrow Smears for Individual Clients for Triage
• Route Spvecimen to Proper Dept for Triage including Histology, Cytology, Molecular and Flow using Tiger Software
• Maintain Slide Filing System and Folder Filing System for Tracking post triaged Cases and Smear Specimens
• Gather Requirements for Slide Scanning Software Aperio Slide Manager and Leica
• Tiger Software Document Management System
• Meet Quality Standards: CLIA (Clinical Laboratory Improvement Amendments) and certified CAP (College of American Pathologists); ISO 15189; (FDA) 21 CFR 58 - Good Laboratory Practice 21 CFR 58, 606 - Good Laboratory Practice for Blood Industry
• Gathers information to write civil liberties book
• Collects, analyzes and documents timeline of 4th amendment changes
• Researches the Constitution as it applies to the people
• Volunteers at assisted living homes as a companion to the elderly

Confidential, Fairfield NJ

Technical Writer/Editor, Engineering Dept

Responsibilities:

• Created Instruction Sheets for Commercial and Residential Sheet Metal Products using Adobe Illustrator.
• Attended meetings for Tracking Project Lifecycle Roadmap of sheet metal fabrications from Inception to Delivery.
• Worked with VP to update SOP's in MS Word for various departments.
• Used ERP software to update and track product information and gather requirements.
• Imported Product Blueprint AutoCad file into Adobe Illustrator for editing.
• LeGrand Document Management System
• Comply with Quality Standards ISO 9001 and ISO 14001 Registration for Quality

Confidential, Raritan, NJ

Business Analyst/Tech Writer |

Responsibilities:

• Documented and Tracked End User functionality of CTMS (Clinical Trial Mgmt Systems) Siebel web application.
• Provided User Acceptance Testing of CTMS Protocol Creation Modules.
• Tested Architecture Permission Access levels of Global Trial Manager, Clinical Trial Manager and End Users.
• Log Validation test results consisting of CTMS Siebel Business Components, including Business Objects, Form Applets, List Applets and Views.
• Attended SDLC Project Life Cycle meetings of Process Improvements, and Tracked Requirements.
• Met with Developers to learn base concepts of Web Methods and XML.
• Obtained J & J e-University s in AE & PQ Compliance and Safe Harbor Clinical Data.
• Document Management System: Micro Strategies
• Quality Standards: Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices (GCDMP) guidelines and ISO 14155. (FDA) ICH E8 - General Considerations for Clinical Trials

Confidential, Franklin Lakes NJ

Business Analyst |

Responsibilities:

• Created Test Plan and UAT Scripts for Bi-Directional Batch Processing RX and Medical Claim Benefit installation architecture. Followed Process Models;
• Collection, Review, Analysis and Documentation of Business and System Requirements throughout Project Lifecycle.
• Liaison between Client, Vendor and Medco.
• Updated MS Project Plan.
• Maintained Vendor Grid Excel Sheet.
• Populated Test Plan based on Individual Client Benefit to ensure proper adjudication of Client Benefits.
• Requirements gathering included architecture network setup, such as FTP/VPN, NDM or FTP Internet; in MQ or through Batch Processing.
• Master Control Document Management System
• Attended daily meetings to verify Use Cases for individual Clients.
• Co-Pay Approval End User for Medco RX clients.
• Provided Approvals using BA Modular ERP Software, RUMBA MF and CPBM web application
• Attended weekly meetings.
• Document End User updates per Modular Release.
• Create SOPs adhering to Quality Standards: ISO ISO/IEC 9126 and ISO/IEC 1 CFR Part 11

Confidential

QA Tester/Tech Writer

Responsibilities:

• Created Test Plans following SDLC CMM model.
• Provided User Acceptance Testing and Documentation for all Modules of PC web Direct Broker-Dealer Applications.
• Met with all divisions of Project Team (DBA's, Developers, Networking Group) in a deadline-oriented testing environment, and gathered requirements.
• Met with SIAC MF developers to verify Back End Processing.
• Performed DB Verification Testing using SQL ODBC Driver to view end user Sybase Table Population.
• Executed Unix Shell Script to catch and verify data on the JCL file en route to MF.
• Received Tier 2 Testing for Mutual Fund QA testing of PCWeb Direct.