+Years of professional experience
SHENELLE JOHNSON
Trenton,OH
Summary
Quality and labeling professional with 15+ years of experience supporting regulated medical device and pharmaceutical environments. Expertise includes new product development labeling, design controls, Instructions for Use and package labeling, technical writing, post-market surveillance, and quality-system documentation. Trusted cross-functional partner who translates regulatory and user requirements into clear, compliant deliverables that support product launches, audit readiness, and sustained quality performance.
Overview
15
15
Work History
New Product Development Labeling Lead
Johnson & Johnson (Ethicon)
Cincinnati, OH
07.2022 - Current
- Lead labeling strategy and execution for new product development teams, developing project plans and coordinating labeling deliverables for product launches.
- Partner with Regulatory Affairs to align labeling and supporting documentation for 510(k) submissions, helping streamline cross-functional review and U.S. approval activities.
- Collaborated with Regulatory, Clinical, Quality, R&D, and Medical stakeholders to align requirements, content, reviews, and timelines as the primary labeling partner.
- Translated product and regulatory requirements into clear, compliant IFU and labeling content through disciplined technical writing and thorough content review.
- Prepared instructions for use and package labeling for formative and summative usability evaluations, emphasizing safety, effectiveness, and user needs.
- Execute labeling design-control deliverables in accordance with local quality-system procedures, ensuring complete and compliant documentation.
- Managed multiple concurrent labeling schedules, identified capacity constraints, and resolved issues through prioritization, timing adjustments, and resource coordination.
- Maintain product-label design and process knowledge for assigned platforms and provide subject-matter guidance to project teams.
Post-Market Surveillance Data Analyst II
Johnson & Johnson (Ethicon)
Cincinnati, OH
05.2018 - 07.2022
- Extracted and analyzed monthly post-market quality data, maintained compliance records, and supported global surveillance efforts, leading to promotion to Post-Market Surveillance Data Analyst II in 2020.
- Executed post-market surveillance data-analysis processes, enhancing quality-data extraction, tracking, trending, and signal detection.
- Reviewed surveillance documentation for compliance with regulatory, technical, and statistical standards; presented findings and recommendations for corrective actions.
- Collaborated with Medical, R&D, Product Quality, Engineering, and Supplier Quality to align priorities and deliver timely surveillance outcomes.
QA Product Release Technician
Johnson & Johnson (Ethicon)
Cincinnati, OH
01.2015 - 05.2018
- Maintained compliance with policies, procedures, Good Documentation Practices, and ISO documentation requirements for product release.
- Improved quality compliance by exceeding required training goals and sustaining QA product-release cycle-time expectations.
- Investigated quality issues, analyzed contributing factors, and proposed corrective actions to enhance product quality.
- Facilitated implementation of business services to successfully introduce new products into service and repair operations.
- Served as subject-matter expert for ETQ nonconformance system, ensuring accurate issue documentation and efficient workflow execution.
- Created, revised, and processed controlled procedures, work instructions, and forms in the EpiCenter document-management system.
- Reduced safety-audit findings in the Service and Repair Center by redesigning the Monthly Housekeeping Audit to strengthen team participation and accountability.
Education
Master of Science - Management
Wesleyan University
Cincinnati, OHBachelor of Science - Chemical Technology
Kent State University
Kent, OHAssociate of Applied Science - Chemical Technology
University of Cincinnati
Cincinnati, OHSkills
- Product development and labeling
- Label design
- FDA 510(k) documentation support
- Technical writing and content review
- Design controls
- Post-market surveillance and analysis
- CAPA and quality issue escalation
- SOPs and instructions
- Project management
- Quality laboratory systems: LIMS, Empower, ETQ, Epicenter, Siebel/CSI, Adaptive, OneMD, Windchill, AS400
- Microsoft 365 proficiency
- Windows operating system
- AI tools
Timeline
New Product Development Labeling Lead
Johnson & Johnson (Ethicon)
07.2022 - Current
Post-Market Surveillance Data Analyst II
Johnson & Johnson (Ethicon)
05.2018 - 07.2022
QA Product Release Technician
Johnson & Johnson (Ethicon)
01.2015 - 05.2018
Master of Science - Management
Wesleyan University
Bachelor of Science - Chemical Technology
Kent State University
Associate of Applied Science - Chemical Technology
University of Cincinnati