Aliso Viejo, California, USA
13 days ago
Sr Specialist, Labeling Design
Design, develop, and update global labeling documents to include product labels, instructions for use (IFUs), patient implant cards, specifications, and technical documentation. Job duties:Develop strategies for continuous improvement of the Labeling program and procedures. Conduct investigations and troubleshooting to address labeling non-conformances and document appropriately per the quality system. Provide advice or consultancy to other teams with respect to labeling implementation processes.Design, develop, and implement changes to new and existing product labels and instructions for use (IFUs) using labeling and design software. Collaborate with labeling change request initiators to understand requirements, design solutions, timelines, and deliverables. Develop standardized and optimized label templates and identify issues associated with design. Ensure labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures, and work instructions.Effectively collaborate with cross-functional groups and stakeholders for successful implementation of labeling designs and changes. Coordinate with suppliers and vendors for outsourced printed products and translated materials. Conduct investigations, root cause analyses, and the development of corrective actions to address labeling non-conformances.  Lead activities to implement corrective actions. Complete labeling initiatives by collaborating with individuals from functional groups and providing solutions to meet objectives. Assign tasks and provide guidance, mentoring direction to the labeling group and contractors regarding labeling workflow, project status, and priorities. Communicate anticipated assignment completion dates to affected coworkers.  Meet timeline commitments with minimal supervision. Perform other responsibilities as assigned.
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