Johnson & Johnson Careers
Senior Labeling Coordinator/Lead
Palm Beach Gardens, Florida
Requisition ID: 0017190719
DePuy Synthes a member of the Johnson & Johnson Family of Companies, is hiring a Senior Labeling Coordinator/Lead in Palm Beach Gardens, FL.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.\
The Senior Labeling Coordinator/Lead will be responsible for ensuring labeling used with or on finished product manufactured in Palm Beach Gardens meets business and global regulatory requirements such as CFR 801 (US) Medical Device Labeling, ISO 15223 Medical Device Symbols, EUMDR, FDA and BSI.
Must have the Project Management skillset to oversee the organization, release, and implementation of multiple product Instructions For Use (IFU) [aka DFU], package labels, translations, and other relevant labeling such as FDA UDI and Direct Part Marking (DPM). Must be able to represent and take ownership of PBG labeling interests on both internal and external project teams while working with regulatory and leadership teams to ensure consistency and compliance.
• Follow appropriate policies for labeling.
• Maintain Quality System procedures and guidance documents related to labeling development and management.
• Works with Corporate peers as needed.
• Drive cross-functional teams to create and/or review updated labeling in terms of the following: label/labeling templates, packaging requirements (e.g. determine size and shape of final labeling design and packaging and sterility impact as applicable)
• Support product labeling initiatives such as the World-Wide labeling project, 2D bar code implementation, harmonized symbology implementation, MDR requirements, updated CE Marking Notified Body Number change, and electronic IFUs (eIFU) as required.
• Develop IFUs and other labeling materials in support of new product development.
• Provide possible solutions to label design issues.
• Create and ensure label design specifications are accurate and that appropriate checks are in place prior to release (e.g. labeling consistency, inspection plans).
• Verify alignment of label content with IFU and ensures labeling designs meets packaging and sterility requirements. Creates/proofs/inspects as required.
• Oversee the completion of activities related to translations and the label stock vendor and verifies proof articles prior to production.
• Propose and implement improvements to the labeling process as deemed appropriate.
• Manage translations with approved translation house.
• Implement process to manage and control eIFUs.
• Assist Quality with investigation activities related to labeling issues.
• Maintain labeling records and control revisions of labeling.
• Route labels for approval in PLM or Change Order system, route for implementation, assist with inventory management and update Device Master Records (DMR) as required.
• Work with Quality in the management of (and Quality Agreements required for) translation service companies and Website URL services.
• Create/maintain Quality System procedures and processes for eIFU creation and website management, to include Change Control, Design Controls Requirements, Functional Design Requirements (FDR), Risk Management, Technical Files etc.
• Perform labeling related verification and validation activities.
• Support special project requirements, e.g. creation of packaging outserts, URL labels.
• Select or create photographs, drawings, sketches, diagrams, and charts as needed to illustrate material; study product specifications and other details to integrate into labeling (e.g. barcodes).
• Must learn/be proficient in Bartender (label design software) to design templates, design sample labels for product registrations or label validation.
• Other duties as required.
• University/Bachelor’s Degree or equivalent work experience in medical/pharmaceutical industry required.
• 4 years’ experience in labeling design within a regulated medical/pharmaceutical industry required.
• Microsoft Office suite proficiency required.
• Experience with quality inspection & non-conformances required.
• Strong capability for relationship building across distances required.
• Must have ability to write clear, concise instructions within operating procedures and as needed to support intended users and other design controls requirements.
• Experience & understanding of labeling certifications such as: CFR 801 (US) Medical Device Labeling, ISO 15223 Medical Device Symbols, EUMDR, FDA and BSI required.
• Attention to detail required.
• MS Project (PMP certification is preferred).
• Excellent time management skills in order to balance/prioritize work with limited supervision; must be comfortable working independently preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Florida-Palm Beach Gardens-
DePuy Synthes Products, Inc (6149)