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Technical Writer Resume Example

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TECHNICAL WRITER
Profile
Senior Validation/Documentation Specialist and Technical Writer with over 10 years of experience in the pharmaceutical industry. Experience includes working in Regulatory Affairs submitting documents to the Federal Drug Administration (FDA). Developed comprehensive software solutions for GxP (GCP, GLP and GMP) which included Compliance Management, Document Management, Change Control, Risk Management and Equipment Management. Hands on validation with experience in LIMS, Applied Bio systems, Lab Ware, 21 CFR Part 11 Compliance Assessment, Vendor audits IQ (installation), OQ (O perational Qualification), GxP, and writing Scripts and Execution. Experience with clinical trial data, as well as Standard Operating Procedures and Production of PSUR's. Experience with Legacy/3rd party systems. Technical writing of computer systems and manufacturing equipment validation,working with GxP systems in compliance to 21 CFR Part 210,211, (Electronic Records).
Professional Experience
Technical WriterApr 2013 to Nov 2015
Non - Pharmaceutical, Voorhees NJ － Somerville, NJ
  • GMPDeveloped manufacturing procedures in engineering and various SOP's.
  • Updated engineering procedures (GMP's).
Technical Writer Software Validation Engineering ConsultantMar 2011 to Mar 2013
Mc Neil Consumer Products － Fort Washington, PA
  • Performed Software documentation life cycle on various programs.
  • Developing/Executing Functional, User and Technical Requirements Specifications (URS/FRS) Developed and wrote Risk Assessment and test scripts for functional and technical documents.
  • Performed document control for SDLC documents, validation documents, and manufacturing, Work instructions associated with SOP's.
  • Performed software validation for Functional and Technical documents using Werum and Wonderware software.
Validation Specialist/Technical WriterMar 2009 to Oct 2010
AstraZeneca － Newark, DE
  • Prepared and audited Batch Records and Master Batch records.) and 820.
  • Knowledge in the following regulations and guidelines: FDA Regulations (CFR Parts 219,211,11, 820 (Quality System Regulation) ISO Standards as applicable to Compute System Validation (ISO 900-3) and Network Infrastructure (ISO 17799 - Security Standard) PIC/S Guides as applicable to CGMP and Computer System Validation ( Good Practices for Computerized Systems in Regulated GxP Environments).
  • GAMP 4 and recently revised GAMP 5, Guidelines and Testing of GxpSystems based on GAMP V- Model Framework.
  • FDA Guidance on Software Validation (General Principles of Software Validation).
  • EU-GMP Annex 11 "Computerized Systems", regulation.
  • Prepared Change Control Requests.
  • Participated in PET meetings on a daily basis with regards to packaging.
  • Insured Regulatory Compliance was met in accordance with FDA regulations.
Technical Writer Project Team LeadAug 2008 to Jan 2009
Teleflex Medical － Reading, PA
  • Prepared documents for archiving off site.
  • Developed website based surveys.
  • Implemented validation life cycle processes.
  • Performed audits on medical devices in preparation for FDA audits.
  • Wrote guidelines with regards to Pharmacovgilance.
  • Prepared Various SOP's and Work Instructions (WI) with respect to QA, QC and manufacturing of Catheters.
  • Also developed System Development Life Cycle (SDLC) documentation from Design specs to decommissioning.
  • Developed validation procedures for GLP and GMP (Arterial Catheters).
  • Wrote SOP's for manufacturing.
  • Upgraded manufacturing process and software systems.
  • Used Legacy/3rd party with various vendors for catheters.
  • Wrote functional and test scripts and execution regarding catheters with respect to financial needs.
  • Interviewed various departments as to the need required.
Technical WriterApr 2007 to Jul 2008
Foundation for the Blind － Philadelphia, PA
  • Prepared and standardized SOP's and documents for internal use.
Validation Document Specialist/Technical WriterMay 2006 to Jan 2007
AstraZeneca － Wilmington, DE
  • Prepared regulatory labeling.
  • Developed Core Data Sheets for Astazeneca products.
  • Prepared, wrote SOP's for manufacturing and product development.
  • Implemented validation life cycle processes (home grown software) Insured regulatory compliance was met.
  • Developed White Papers.
Validation Specialist/Technical WriterApr 2005 to Mar 2006
Sanofi-Aventis － Malvern, PA
  • Prepared and developed Standard Operating Procedures (SOP's) for the Pharmaceutical Prepared Good Manufacturing Practice (GMP) documents and for submission to the Food and Drug Administration (FDA).
  • Prepared and developed Standard Operating Procedures (SOP's) Science DPT and Good Manufacturing Practice (GMP) specifically pharmaceutical manufacturing equipment.
  • Prepared and organized documents for future audits.
  • Developed, released Batch Records for capsule production.
  • Managed Change Control process.
  • Developed manufacturing manuals for various encapsulating machines.
  • Wrote guidelines with regards to Pharmacovigilance.
  • Experience includes developing Manufacturing SOP's for capsules.
  • Experience includes pre - Clinical and Clinical management.
  • Also extensive electronic Data Capturing.
  • Experience includes all phases of SDLIC validation and functional tests and execution of scripts.
  • Performed LIMS software validation of analytical instruments.
  • Performed validation for GMP (Capsule manufacturing) Upgraded software for encapsulating manufacturing equipment.
Validation Specialist/Technical WriterMar 2005 to Apr 2005
Centocor Johnson & Johnson － Malvern, PA
  • Developed and wrote SOP's (Research & Development Systems) Performed PC Validation and Life Cycle documentation.
  • Converted lab notebooks to electronic files.
  • Updated electronic filing using Documentum (e-Files and Meta Data programs).
  • Developed complex and technical design specifications for use in the Regulatory department as related to Quality Assurance (QA) and manufacturing.
  • Developed and documented laboratory procedures.
Document Specialist/Technical WriterDec 2004 to Mar 2005
Merck Pharmaceuticals － West Point, PA
  • Assisted in developing team priorities and policies for the IT Dpt.
  • Wrote SOP's for Regulatory Affairs.
  • Prepared and developed SOP's for c-GMP's.
  • Developed Universal Labeling System.
  • Developed and designed technical procedures for retrieving archived specifications.
Validation & Document Specialist/Technical WriterJun 2003 to Nov 2004
Ortho Diagnostic － Raritan, NJ
  • Prepared and submitted IND and ANDA documents to the FDA.
  • Prepared specifications Functional Specifications (FS), Design Specifications (DS) and instructions for manufacturing of Serological testing devices.
  • Held Quality Assurance (QA) and Quality Control (QC) Departmental meetings.
  • Prepared documentation for implementation of Enterprise Resources Planning (ERP) system.
  • Trained manufacturing personnel in kit assembly Provided assistance in setting team priorities.
  • Planned and conducted information gathering information.
  • Edited and corrected errors generated by other consultants.
  • Prepared and wrote SOP's for Functional Requirement Specification (FRS), Detailed Design Specification (DDS).
  • Prepared SOP's for computer systems validation documents Computer System Validation (CSV), Inspection Quality (IQ's), Operational Quality (OQ's) and Production Quality (PQ's).
Technical WriterSep 2002 to May 2003
Union Carbide Corporation － Bound Brook, NJ
  • Prepared and wrote Functional and Design specifications.
  • Conducted briefs and presentations to upper management regarding the development of new products.
  • Wrote a technical paper describing the history and specifications for Polyarylsulfone for use in the American Chemical Society's annual conference.
  • Prepared and wrote SOP's for technical specifications, and manufacturing manuals for various types of plastic manufacturing.
Technical WriterFeb 2002 to Aug 2002
Engineered Arresting Systems － Aston, PA
  • Prepared and wrote Overhaul manuals for Arresting Gear systems for military and commercial aircraft.
  • Submitted documentation to the Federal Aeronautics Aviation (FAA).
  • Developed manuals for installation of equipment ordered by customers.
Technical WriterDec 1999 to Jan 2002
Ethicon Inc － Somerville, NJ
  • Standardized the manufacturing process for needles and sutures for 5 Ethicon plants.
  • Wrote Engineering Standards Manual.
  • Developed Administration manual with respect to manufacturing.
  • Developed manufacturing procedures for needles and sutures including software.
  • Interviewed the necessary departments to develop the standards for functional and testing standards.
Document SpecialistSep 1999 to Dec 1999
Amersham Pharmacia Biotech － Piscataway, NJ
  • Developed and implemented Computer Validation lifecycle documentation.
  • Updated SOP's and validation for Current Good Manufacturing Procedure (c-GMP).
  • Developed and maintained Request and Change Control systems.
  • Held interdepartmental meetings regarding DNA sequencing components.
  • Standardized manufacturing process for 3 US plants.
  • Utilized Polymerase chain reaction (PCR), and Reverse transcription Polymerase chain reaction (RT) in developing DNA sequencing and testing.
  • Updated analytical testing procedures for QA and QC departments.
  • Updated documentation for Laboratory procedures.
Education and Training
B.S, Oceanography/Biology/ChemistryLong Island University － Southampton, NYOceanography/Biology/Chemistry
Affiliations
Member: Society for Technical Communicators
Skills
Windows 95/98/NT/2000, XP, Windows 7, MS Office (Word and Excel Power Point), Share point, UNIX VI, Editor, Lotus Notes Visio, PC Validation (SDLC), ERP/MRP systems, Documentum, Meta Data Base and Panagan programs, Global Regulatory requirements, Archiving, Share Point, Werum, Wonderware, Pilgrim, safety PSUR Citrix, e-Survey SOP's, Work Instructions (WI), Software and System Held interdepartmental meetings regarding DNA sequencing components. Standardized manufacturing process for 3 US plants. Utilized Polymerase chain reaction (PCR), and Reverse transcription Polymerase chain reaction (RT) in developing DNA sequencing and testing. Updated analytical testing procedures for QA and QC departments. Updated documentation for Laboratory procedures. Developed System Documentation Life Cycle (SDLC).
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Resume Overview

Companies Worked For:

  • Non - Pharmaceutical, Voorhees NJ
  • Mc Neil Consumer Products
  • AstraZeneca
  • Teleflex Medical
  • Foundation for the Blind
  • Sanofi-Aventis
  • Centocor Johnson & Johnson
  • Merck Pharmaceuticals
  • Ortho Diagnostic
  • Union Carbide Corporation
  • Engineered Arresting Systems
  • Ethicon Inc
  • Amersham Pharmacia Biotech

School Attended

  • Long Island University

Job Titles Held:

  • Technical Writer
  • Technical Writer Software Validation Engineering Consultant
  • Validation Specialist/Technical Writer
  • Technical Writer Project Team Lead
  • Validation Document Specialist/Technical Writer
  • Document Specialist/Technical Writer
  • Validation & Document Specialist/Technical Writer
  • Document Specialist

Degrees

  • B.S , Oceanography/Biology/Chemistry

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