TECHNICAL WRITER EDITOR DOCUMENT CONTROL SPECIALIST

Versatile, approachable seasoned healthcare industry professional with over 12 years of global quality assurance and regulatory compliance experience, spanning medical devices, pharmaceutical, clinical research, and debt collection sectors. Gifted with above average intelligence, and efficiently creates instructional design. Quickly adapt skills and knowledge to flex with company needs. Positions include Regulatory Clinical Document Specialist, Technical Writer, and Document Control Specialist, using SAP, Documentum, Agile, MS Access, Cloud, Visio, Adobe InDesign, MS Office, J.D Edwards (AS-400), WindChill, and writing in AP Style Writing

oStrategic decision-making and tactical document design, a team member in successful implementation and delivery of multi-functional million-dollar contracts. Fine detail in writing and editing with close attention to quality control

oExceptional analytical and research skills with proven ability to assess and meet company needs

oOutstanding oral, written, and listening skills, relating to coworkers with integrity and positivity

EDUCATION

Theology Major, Elementary Education Concentration, Oral Roberts University, Tulsa, OK

Computer Courses (MS Office Suite, Adobe, Documentum), Springhouse Computer School, Exton, PA

PROFESSIONAL CONTRACT EXPERIENCE

Medtronic / HCL, Senior Technical Lead Writer, Los Angeles CA, November 2021 – April 2023

Medical Device Company

oManaged document approval processes, workflows, and lifecycle for Diabetes Unit through full lifecycle in the AGILE document management Oracle solution, using the Cloud Platform and AP Style Writing

oAnalyzed current business processes and offering suggestions to senior management to improve / optimize them

oUpon receiving a set of documents from an engineer, created an initial release (Version A) or moved the document to the next version (e.g., Version C to Version D). Labeled filenames according to convention

oCreated document "shell" in Agile database with cover page document information to house final master, redlines, and supporting documents

oInitiated a documentation review workflow. Each document type (e.g., Engineering Test Report) had a specific set of reviewers. Assigned reviewers based on document type. Monitored documents until approved and finalized

FMS, Inc., Document Control Specialist, Tulsa OK USA, April 2020 – September 2021

Debt Collection Company

oManaged debt collection letters, using FACS database

oCreated, edited, and maintained compliance for debtor letters

Capital One Auto Finance, Account Manager & Customer Liaison, Tulsa OK USA, July 2019 – November 2019

Auto Finance Company

oTelephone collections for late car payments in pre-repossession

Thermo-Fisher Scientific – Patheon, Technical Writer, Greenville NC USA, July 2018 – December 2018

Pharmaceutical Company

oRearranged, proofread, edited in Track Changes, and formatted complex batch records / work instructions / manufacturing instructions / instructions for use (IFUs) filling work orders for parenteral sterile liquids production instructions for manufacturing, applying GMP. Worked with a team to create product specific based batch records. Participated in meetings with SMEs for internal review and revisions, using the Cloud Platform and AP Style Writing

Lonza AG Pharmaceutical Company, Technical Writer, Walkersville, MD USA, August 2017 – November 2017

Pharmaceutical Company

oWrote instructions for use (IFUs) in AP Style Writing, proofread, edited in Track Changes, and formatted complex preventive maintenance SOPs, Work Instructions and forms for factory equipment and systems in preparation for Computerized Maintenance Management System (CMMS/SAP), using Visio, Adobe InDesign, MS Office, and more, applying GMP, using the Cloud Platform

oImplemented QMS standards and development, along with approved procedures and data flow of Document Control Department

Alcon Precision Device Facility, Technical Writer, Sinking Spring, PA USA, May 2016 – August 2016

Medical Device Company

oWrote, proofread, edited, and formatted complex validation protocols, SOPs, and test methods for installation of factory equipment

oUpdated engineering drawing logbooks

Siemens Healthcare Diagnostics, Technical Writer, Newark, DE USA, September 2014 – November 2015

Medical Device Company

oWrote instructions for use (IFUs) in AP Style Writing, proofread, edited in Track Changes, and formatted complex validation protocols, SOPs, and test methods for installation of factory equipment and preventive maintenance

oProofread and revised hundreds of vendor specification documents to update for new SAP system. Entered and searched for data for components and materials in SAP.

oProcessed change control and deviation documentation for factory equipment SOPs, preventive maintenance, and floor procedures

oInspected and marked up artwork and vendor proofs, comparing them with approved graphics. Processed revised artwork and documentation for routing for approvals and entry into Documentum

Synthes DePuy, Inc., Document Coordinator, West Chester, PA USA, October 2013 – April 2014

Medical Device Company

oCoordinated thousands of documents and their data on spreadsheets in a sterility project in the Toxicology Department as an initiative to avoid a CAPA, after bone parts were found to cause infections in bone implant patients

oCoordinated sending out bone replacement parts for lab testing to determine toxicology

oPrepared and proofread electronic documents for the BIOCOMP Remediation Team, using J.D Edwards (AS-400), Word, Excel, Visio, PowerPoint, and multiple database software programs to research information on bone implant parts

oDrafted & proofread Biological Safety Evaluations (BSEs), Chemical Characterization Test Protocols (CTPs), incorporated Manufacturing Process & Material Description data

Siemens Healthcare, Technical Writer, Newark, DE USA, January 2013 – October 2013

Medical Device Company

oRevised and proofread outlines and formatting for a set of manufacturing procedures instructions for use (IFUs) for chemical conjugates and SOPs for equipment use and preventive maintenance to make drug tests in compliance with FDA standards

oTracked and proofread batch records for GMP compliance

oDocument changes on tens of documents to update for new SAP system

oProcessed change control and deviation documentation for factory equipment SOPs, Work Instructions, and preventive maintenance procedures

Nutramax Laboratories, QA Batch Records Specialist, Edgewood, MD USA, September 2011 – October 2011

Nutraceutical Company

oProject Manager for revision and expansion of equipment SOPs, Work Instructions (Instructions for Use - IFUs), machine operator testing program, preventive maintenance signs, complaint forms, changes control forms, deviations, and training module for manufacturing and packaging operations and preventive maintenance

oConsulted with SOPs and SMEs (Manufacturing and Packaging Managers, Department Heads) to compile, proofread and develop machine operator testing program. Interviewed machine operators and studied manufacturing line operations on the floor to create most efficient, sterile, thorough testing

Merck, Inc., Technical Document Control Specialist, West Point, PA USA, April 2009 – November 2010

Pharmaceutical Company

oOrganized, indexed, proofread, and archived voluminous files for Biologic Critical Reagents in compliance with FDA standards and cGMP

oManaged Project to write, revise, and proofread outline and format of set of 150 qualification protocols, Instructions for Use (IFUs) for preventive maintenance and equipment SOPs, and batch records for conversion to Quality Management Standards in compliance with FDA standards and GMP

oProcessed change control and deviation documentation for vaccine testing procedures

Synthes, USA, Batch Record Technical Document Project Manager, West Chester, PA USA, January 2009 – March 2009

Medical Device Company

oMajor restructuring of formatting for manufacturing equipment SOPs / batch records for existing and new medical device products in compliance with FDA standards and cGMP

oCreated new table format for batch records and wrote, reformatted, and proofread equipment SOPs and batch records company wide

Teleflex Medical, Project Technical Writer, Reading, PA USA, July 2008 – October 2008

Medical Device Company

oTeam member for non-conformance investigation (NCs), Corrective Action and Preventative Actions (CAPAs), and Consent Decree

oCreated, proofread, and edited technical graphics documents in Adobe Acrobat and charts in Excel for a medical device company, as a quality control measure to ensure inspectional procedures were uniform in compliance with FDA standards and cGMP for new product development

oInput revised documents into AGILE Document Control Program

Cephalon, Inc., Records Management Analyst, West Chester, PA USA, December 2007 – July 2008

Pharmaceutical Company

oEfficient electronic imaging, retention, proofreading and classification of regulatory and clinical documents in compliance with FDA standards

Sanofi-Aventis, Inc., Regulatory and Clinical Document Coordinator, Malvern, PA USA, February 2006 – November 2006

Pharmaceutical Company

oResponsible for writing, editing, and proofreading initial stages of protocols and clinical study reports; reformatted existing clinical study reports, conferring with medical writers in Documentum to maintain GCP and GDP functional specifications in compliance with FDA standards

oResearched, proofread, and compiled data for Question & Answer response submissions to FDA

oResponsible for preparation, proofreading, organization, processing and reporting all client safety information for strategic development programs across Phase II - IV clinical trial programs

oWrote Instructions for Use (IFUs) for patients involved in clinical studies

Centecor, Inc., Archive Assistant, Malvern, PA USA, May 2005 – September 2005

Pharmaceutical Company

oIndexed and boxed paper files for scanning, following up by quality control validation before placing in Documentum in compliance with FDA standards

oEntered, updated, proofread, and looked up data on files on computerized system

oDemonstrated excellent teamwork, communications, and sound decision making abilities

Viropharma, Inc., Regulatory Document Specialist, Lionville, PA USA, April 2001 – August 2002

Pharmaceutical Company

oProject Manager for company’s first eSubmission of Investigational New Drug (IND) application and clinical study reports for FDA submission, in compliance with GCP and GDP in 21 CFR Part 11, using primarily MS Word, Adobe Acrobat, and EZ Subs Documentum

oFormatted, proofread, and edited medical documents in Track Changes, such as protocols and study reports, to meet AMC guidelines, implementing QMS standards and development

oCreated and proofread training module instructions for use on how to compile a clinical study report

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