Labeling Specialist #1018698

Assists in the timely development and completion of helping compile, maintain, and review labeling documentation, including drawings, change orders, and specifications, ensuring accuracy and compliance with GMP and QSR standards. This includes developing labeling designs using standard templates and style guides. The role helps to manage digital and hardcopy records (as needed) in the document control systems, resolves discrepancies, and verifies that labeling changes are supported by data and are consistent with applications.

The role requires close collaboration with R&D, R&D Packaging Engineers, Legal, Product Marketing, Regulatory Affairs, Design Assurance, Quality, Manufacturing, and Operations to support customer satisfaction and patient safety.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.

• Support setup of labeling design (new or changes) using the Neurovascular labeling system and software tools (GLS/Prisym, Adobe Products, MS Office, etc.).

• Use onsite label printers (e.g., Zebra), barcode grader, or other equipment (as needed) as part of the label setup for new or changed labels.

• Troubleshoot printer issues (as needed) • Support for labeling verification procedures and collaboration with Operations (as needed) to implement labeling in production.

• Actively participate in project team meetings. Coordinate and monitor project task execution and project progress against deliverables.

• Uphold the Quality Policy by maintaining compliance with all quality requirements and supporting process improvements for easier compliance.

• Support updates to technical documentation (SOPs, Work Instructions, technical literature, engineering work products) that is accurate, consistent in style, and appropriate for the intended audience.

• Review and ensure accuracy of other technical publications and labeling, maintaining strong attention to detail and zero documentation escapes.

• Maintain documentation compliance using site-specific data management systems (i.e., PLM).

• Participate in problem-solving initiatives to address technical issues and document resolutions within the quality system.

• Support updates to departmental and quality system SOPs, Work Instructions, forms, and templates with graphical content, and provide input for training and communication materials.

• Work cooperatively with other functional groups and project managers to coordinate labeling review and approvals.

Dexian stands at the forefront of Talent Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.