Senior Technical Writer Regulated GMP Documentation Expert

Mary Beth Wolfe

PROFESSIONAL SUMMARY

Mary Beth is a senior technical writer with over 20 years of experience producing highquality documentation in regulated GMP environments, including FDA and FAAgoverned industries, as well as in complex commercial and technologydriven settings. Throughout her career, she has specialized in authoring, revising, and standardizing Standard Operating Procedures (SOPs), work instructions, and compliance documentation, ensuring accuracy, traceability, and adherence to regulatory requirements. She is highly experienced in collaborating with crossfunctional teams, including subject matter experts, quality, compliance, compliance, product managers, and IT, to translate complex technical and procedural information into clear, userfriendly content.

Mary Beth has led and supported SOP development for manufacturing, warehouse operations, onboarding, software platforms, and corporate departments, often working within formal document control systems such as SharePoint, Oracle, NetSuite, and enterprise ERP environments. Her background includes handson experience at regulated organizations such as Ethicon EndoSurgery and aerospace and defense manufacturers, where she supported GMP, FDA, and FAA compliance through controlled documentation, change management, audit readiness, and formal signoff processes. Known for her strong project management skills and clientfocused approach, Mary Beth consistently delivers wellstructured SOPs and procedural documentation that align with regulatory standards while meeting the practical needs of diverse enduser audiences.

PROFESSIONAL EXPERIENCE

Standex Electronics Fairfield, OH 08/04/2025-11/03/2025

Technical Writer

08/04/2025-11/03/2025-hired for short-term project

The goal of the project was to incorporate all documentation into an Oracle playbook using diagrams, charts, Matrix Models and KPI's

Translated complex documentation into user-friendly and concise documentation

Incorporated/revised test scripts from Oracle into other platforms

Worked with Oracle SME's, tracking the project in Excel

Developed documentation for a wide range of software and platforms to support implementation both within the country and abroad.

Reviewed Al information for accuracy before implementation into documentation

Used SharePoint to keep all documents safely stored and protected

Followed all applicable regulatory requirements

Ensured information cross-referenced as applicable

US Bank Cincinnati, OH 45227 09/26/2024-05/15/2025

Document Control/Technical Writer

09/26/2024-05/15/2025-hired for nine-month project

Developed, Proofread, and Revised Procedural Documentation: Authored, edited, and standardized corporate banking procedures, ensured accuracy, clarity, and consistency across departments. Collaborated closely with subject matter experts (SMEs) and compliance teams to align content with evolving industry regulations and internal policy requirements

Created Internal Learning and Training Materials: Designed and produced a variety of internal learning assets, including step-by-step guides, reference materials, and onboarding documentation to support employee training and knowledge retention across business units

SharePoint Administration and Team Collaboration: Used SharePoint as a centralized platform for document storage, version control, team communication, and processing documentation. Structured content repositories for intuitive access and ensured alignment with document governance standards

Technical Documentation and Infrastructure Navigation: Accessed internal banking systems (Service Now) and technical platforms to gather insights and composed clear, user-friendly platform documentation. Translated complex technical processes into accessible content for business users, enhancing usability and reducing knowledge gaps

STRATACACHE Dayton, OH 45402 11/15/2013 to 11/20/2023

Senior Technical Writer 11/20/2020 to 11/20/2023

Effectively translated highly technical procedures into easily understood documentation

Responsible for the completion of the warehouse Standard Operating Procedures, on-boarding processes, and role documentation in NetSuite

Developed comprehensive user guides for proprietary in-house software, authored Help documentation, hardware manuals, and concise Quick Reference sheets

Researched, planned, developed, and supported new and existing technical documentation

Technical Writer 11/15/2013 to 11/20/2020

Strong Project Management skills/ allocating time based on organizational needs

Partnered with product managers to ensure content was targeted toward the appropriate audience and consistently upheld technical accuracy

Created documentation for Digital Menu Boards used by prominent clients in the QSR sector, focusing specifically on both administrative and entry-level user roles

AMP (ActiVia Media Platform) User Guide-500+ page user guide documenting the software functionality as well as an explanation of each role in the RBAC (Role Based Access Center), all Dashboard features, glossary, and appendices

Wrote user specifications and guides for the new tablet line ensuring accuracy and simplification whenever possible with SMEs

AMP User Guide-500+ page user guide documenting the software functionality as well as an explanation of each role in the RBAC (Role Based Access Center), all Dashboard features, glossary, and appendices

Wrote user specifications and guides for the new tablet line ensuring accuracy and simplification whenever possible with SMEs

Dealer Specialties-Dominion Enterprises Monroe OH 45050 05/12/2004 to 09/11/2013

Technical Writer/Business Analyst

Created user videos

Created and maintained all software documentation for the Field Services Team

Employed RoboHelp to develop comprehensive Help resources for various forms of end- user documentation

Developed SOPs for multiple corporate departments

Updated spreadsheets with VIN, Model, Trim, and Package in Spanish, French, and English

Worked with the Polling and Accounting teams to manage data

Ethicon Endo-Surgery Cincinnati, OH 45245 04/1996 to 11/2000 and 03/01/2003 to 11/01/2003

Technical Writer

Worked as a contractor in several departments at Ethicon including compliance, customer service, and research and development for many years

Wrote compliance documentation and ensured documentation went to each department/location with proper sign-off measures

Ensured all documentation was filed in the EpiCenter (Enterprise Resource System) and that all changes were documented according to company protocols

Received awards and commendations for work efforts and compliance efforts

Responded to MedWatch customer incident reports within 24 hours

Constantly engaged with development teams and other customer-facing SMEs to develop user-interface documentation

EXPERIENCE IN AVIATION

DHL-CVG 1991-1997

Lockheed Martin 2000-2001

10525 Chester Rd. Cincinnati, OH 45215

Technical Publications/Manuals editor

Ensured the highest level of accuracy in editing aviation documentation for the world's number one defense contractor including engine manuals, user manuals, technical procedures manuals and specifications

In-depth research of DC-8 Aircraft to ensure accuracy for DHL-DC-8 fleet

Revised outdated customer manuals

Made documentation user friendly for international affiliates

Successfully adhered to strict governmental guidelines (FAA and GEAE) ensuring customer continuity of Air Flight schedules particularly Weight and Balance manuals

Lead department in productivity (pages per hour) and (lowest error rate)

Thrived in a quickly changing environment with a quick willingness to adapt to constant change

Oversaw preparation of illustrated materials, drawings, sketches, diagrams, and charts

Outstanding technical skills including training of ISO 14001 and GMP

Maintained Aviation Library

Created Aviation manuals for the 727 fleet

Worked closely with FAA

Worked closely with SME (pilots, engineers, mechanics, miscellaneous staff)

Upheld all regulatory compliance standards

Service Bulletins

Simplified English for Aviation

FDA EXPERIENCE

Effectively edited direct correspondence to customers by revising content and updating the relevant database records.

Lead global editing process regarding FDA mandates. Improved accuracy and liability issues while making the documentation more user-friendly

Revised outdated customer service manuals elimination duplication and costly waste of time

Implemented market research and analysis of retail customer service and customer satisfaction

SKILLS

Microsoft: Word, Excel, Power Point, Outlook, Teams, SharePoint

RoboHelp, ServiceNow, Adobe InDesign, Frame Maker, Page Maker, and Captivate

Worked with AMP- (ActiVia Media Platform (proprietary software)

Worked with CM-Constellation Manager (proprietary software)

EpiCenter (Enterprise Resource Program)-Ethicon Endo-Surgery

Proofreading-Visual Help Pro-HTML, SGML

EDUCATION

Northern Kentucky University, Highland Heights, KY-41099

Bachelor of Arts (History major/Business minor), 1995 graduate

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