Technical Writer Change Management

Sharon Miller

Livonia, MI ***** 248-***-**** **********@*******.*** www.linkedin.com/in/sharonmmiller

Professional Summary

Experienced Engineering Documentation Specialist/Senior Content Developer (20+ years) in regulated sectors (pharmaceutical, biotech, IVD). Independently simplifies complex information, producing accurate PMA and other documentation compliant with GxP, ICH, ISO 9000, and CFR21. Collaborates seamlessly, creating/revising design and documentation of pharmaceutical processes, change management and validation documents (plans, protocols, reports). Maintains templates, guidelines, and version control. Experienced in training development and delivery. Adaptable, organized, detail oriented. Committed to high-quality documentation.

Skills

Technical writing, formatting and proofreading of PMA documentation

Hardware and software documentation

Policies and Procedures (SOPs, WIs, Validation

Protocols, Manuals, SDSs, IFUs, DCRs)

Regulatory requirements (FDA, EMA, EU, USP, ICH, ISO)

Leadership and supervision

Team building and collaboration

Problem solving and analytical skills

Excellent written and verbal communication

Documentation management systems

Microsoft Office Suite, Visio, Sharepoint, OKTA

DITA and XML authoring

SAP, MES

Adobe Acrobat Pro, InDesign, Illustrator

SolidWorks, Inkscape, Snagit

HTML/CSS, UX/UI, JavaScript, JQuery, Ajax, JSON, Dreamweaver, Photoshop

Work History

Technical Writer, 08/2023 - 11/2023

GE Healthcare (Codeworks, LLC) – Wauwatosa, WI

Developed and managed an extensive product catalog in Excel, enhancing precise communication within global teams.

Ensured regulatory compliance and enhanced user experience through the update and revision of product labels and user guides for medical devices. Incorporated critical safety information, version control, and branding elements in multiple languages using Adobe Illustrator and InDesign.

Collaborated with cross-functional teams to gather information for accurate and comprehensive documentation.

Technical Writer, 11/2020 - 02/2023

Varian Medical Systems (Roth Staffing) – Austin, TX

Increased operational efficiency and maintained adherence to FDA regulations and industry standards by streamlining business processes for more than 200 pieces of medical device manufacturing equipment involved in PMA testing of product, including validation protocols (IQ, OQ, PQ), final validation reports, WIs, SOPs and IFUs.

Managed document control, change management and versioning to enhance access to critical documentation and compliance with regulatory audits/submissions.

Collaborated effectively with cross-functional teams, including engineering, quality assurance, and regulatory affairs, to gather and analyze technical information for accurate and comprehensive documentation.

Proactively sought additional responsibilities beyond assigned tasks, including supporting new production line integration in SAP MES, developing and implementing training processes for medical device equipment preventive maintenance.

Performed meticulous validation document audits, ensuring accurate data records, valid signatures, and highlighting any possible regulatory risks per CAPA for an effective quality management system.

Technical Writer, 05/2018 - 05/2019

Thermo Fisher Scientific (Chipton-Ross, Inc.) – Austin, TX

Developed and maintained clear, accurate business process and change management documentation (IFUs and field service manuals) for PMA testing of IVD devices, ensuring adherence to FDA and cGMP standards.

Collaborated with global cross-functional teams to create and revise comprehensive and compliant technical content, utilizing inputs from diverse areas such as engineering, statistics, software, regulatory affairs, and quality assurance.

Coordinated the translation and localization of user guides, ensuring accessibility and compliance for a global audience.

Technical Writer/Medical Technologist, 05/2017 - 03/2018

University of Michigan Hospital, Dept. of Pathology, Microbiology – Ann Arbor, MI

Reviewed and edited medical laboratory procedures using a document management system to enhance clarity, accuracy, and compliance with regulatory requirements.

Conducted comprehensive reviews of IVD medical device documentation, verifying compliance with FDA, GxP, CLIA and other industry standards.

Compiled and drafted technical content for a multi-million-dollar IVD medical device project, aiding in the creation of innovative specimen processing automation solutions.

Technical Support Specialist, 09/1998 - 05/2017

BD Diagnostics – Sparks, MD

Provided comprehensive technical and customer support by highlighting product knowledge and troubleshooting skills, resulting in enhanced customer satisfaction and adherence to regulatory requirements (FDA, GxP, ISO, ICH).

Improved the clarity, accuracy, and usability of more than 300 business process documents, such as technical manuals, product labels, and user guides, across a range of product lines for biotechnology, pharmaceutical, animal and human vaccine, bioremediation, clinical and industrial microbiology markets.

Performed numerous literature searches on products and methods to update bibliographic data.

Displayed proficiency in scientific and technical communication by publishing technical reports and white papers in recognized industry journals.

Escalated critical incidents requiring specialized expertise to appropriate departments, facilitating swift resolutions.

Developed and implemented training for use of complaint system documentation.

Technical Writer, 01/2011 - 05/2012

bioMérieux, Inc. – Lombard, IL

Managed the development and maintenance of accurate, comprehensive technical data sheets to guarantee adherence to industry standards (FDA, GxP, ISO, ICH).

Ensured the accuracy and relevance of technical documentation by conducting comprehensive literature searches utilizing a variety of online and internal resources.

Effectively utilizing internal document management systems, accessed and verified critical information leading to the development of high-quality documentation.

Education

Global Information Technology - Detroit: Web Professional

Graduate Management Studies: Business Administration and Management

University of Detroit Mercy - Detroit

Bachelor of Science: Medical Technology

Wayne State University - Detroit

Certifications

Registry of Medical Technologists, MT (ASCP) 104420

Web Professional, Global Information Technology

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