Madison, Ohio ***57
Summary Labeling Specialist and Tech Writer with a strong sense of organization. Experience in managing multiple projects and developing and maintaining the flow of production. Self-motivated with excellent customer service skills and schedule management.
Skills Experienced in aspects of Quality, Customer Service, Document Control, Graphics and Labeling, Microsoft Word for Windows, Microsoft PowerPoint, Excel, FrameMaker, Adobe Illustrator, Acrobat, PLM/SIM, Structured Authoring, Air Table, Vasont, Proofreading, Order Entry, Scheduling, Shipping and Receiving, Invoicing, Inventory Management and Calibration.
May 2022 - Present
Acolad Group Remote
Digital Content Writer
Develop and implement complex content strategies to ensure consistent, harmonized, and compliant quality of content.
Participate in and sometimes facilitate meetings to explore all angles of ideal patient-centric content.
Maintain a broad understanding of all business products and technologies, ensuring consistent voice and messaging across devices and software.
Communicate effectively to build consensus among stakeholders and teams.
Research industry-related topics (combining online sources, interviews, and studies).
Write clear copy to promote the successful management of diabetes.
Understand stakeholder requirements and track to ensure all are met in outputs.
Develop a cohesive content strategy with structured writing using Content Management Systems.
Manage reviews with stakeholders for input and approval.
Develop systems to accurately generate, deliver, and keep up-to-date records of all Research & Development content.
Manage and follow content style, tone guides, and glossaries, ensuring all-around consistency.
Experience with structured writing, especially XML-based, DITA, and Component Content Management Systems (CCMS).
Successful content writer with familiarity in the medical space.
Experience in working under regulatory and clinical restrictions.
Jan – May 2022
STERIS Corporation Mentor, OH
Product Labeling Specialist
Encompass development and maintenance of medical device product labeling, informational and instructional literature, packaging, internal document control, change control, process control, and implementation of required regulations and guidelines.
Interface with R&D scientists, engineers, engineering designers, graphic design team, regulatory and quality personnel, supervisors, project team leaders, managers, marketing personnel, operations personnel, vendors, and others to gather information for new or revised product labeling.
Assist with project management activities, such as determining department and project priorities, resource allocation, and schedule planning.
Coordinate product labeling project tasks through creation, development, completion, and release to production via the engineering change process, assessing the best combination of resources to complete projects on time.
Develop project-supporting documentation as assigned, including scientific documentation, risk management documentation, and online matrix databases and documentation.
Ensure and verify accuracy and completeness of documentation produced, including proofreading, completing and maintaining design control/project documentation, obtaining necessary approvals, and releasing to operations for production.
Initiate and set up project development and labeling review packets/folders using engineering drawings, design files, visual references, and research.
Possess excellent ability to observe detail, attention to consistency and standard practices regarding product labeling.
2016 - 2022
Technical Writer and Editor / Translation Coordinator
Creation and revision of technical documents for capital equipment and consumable products including, but not limited to, capital equipment technical data, uncrating instructions, installation instructions, operator manuals, maintenance manuals, and consumable technical literature
Create and edit content using XML and authoring tools (PLM/SIM and Arbortext) for technical documentation
Work with product and service engineers to implement engineering changes affecting product documentation
Proofread documents for readability, grammar accuracy, consistency with corporate standards, and completeness. Obtain signed approvals as required.
Responsible for self-direction in scheduling workload and prioritizing tasks.
Experience managing multiple projects and meeting deadlines
Assist department personnel in determining department/project priorities and resource allocation.
Coordinate translations of product documentation as directed by Marketing, Engineering, and/or Management through Structured Authoring
Coach team members with navigation through PLM and Structured Authoring with SIM
Backup OnBase Admin for team
2008 - 2016
Graphics & Documentation Coordinator
Ensures label and packaging designs accommodate and comply with Hazardous Materials / Dangerous Goods classification, FDA, EPA and DOT regulations
Maintain / Redesign / Revising & proofing of all labeling for consumable packaging based upon Corporate Communications guidelines and standards, the Quality Systems Regulations CFR 49, CFR 21 Part 820, ISO 13485, ISO 9001, CE Mark, FDA and EPA requirements.
Circulate electronic artwork approvals and Engineering Change Notices, working in conjunction with Operations, Regulatory Affairs, Marketing, and Quality Systems
Develop / Revise / Release facility documentation including Policies, Procedures, Work Instructions, Forms, and drawings in (Product Lifestyle Management) PLM and MRP databases
Review Art and Drawings for correct manufacturing specifications for all new and revised art
Distribution of newly released and updated documentation per resolved Engineering Change Notices (ECN’s)
Work with Printing vendors for approvals of final labeling artwork
Instrumental in initiating cost savings for the company by switching Calibration vendors
Lead for transferring all Calibrated items to a new Vendor and assisted in creating an online database for Steris’s calibrated items and all their information so the equipment owners could reference the database instead of waiting for monthly reports to schedule their calibrated items
Maintain Calibration database and monthly reports
Local “subject matter expert” for the PLM system at the Hopkins facility
Approval of Manufacturing and Chemical Device History Records (DHR’s)
Assist in creating a training database for employees for audit compliance
Participate in Manufacturing LEAN events
Support production on labeling for zebra printers
Education - Bachelor of Art and Applied Media Arts
Translation Project Management – Online Course
Adobe DITA Conference 2019
Introduction to DITA online course
Minimalism: Creating Information People Really Need - Online Course
Professional Technical Writing/Intro to XML - Online Course
STOP Safety Training Orientation Program
Achieving Extraordinary Customer Service Seminar
Lakeland Community College – Certified Pharmacy Tech Program
Edinboro University of Pennsylvania – BFA/AMA
Minor: Speech and Communication Studies