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Job Title: Labeling Specialist

Location: Pleasanton, CA - 94588

Duration: 12 Months

Shift: 8 AM to 5 PM

Job Summary:

The Labeling Specialist will handle labeling processes and UDI (Unique Device Identifier) management, ensuring compliance with regulatory and company requirements. This is an onsite position requiring collaboration with cross-functional teams and the ability to manage multiple projects simultaneously.

Responsibilities:

• Create and manage labeling and UDI change processes in document management systems.
• Design and modify product labels to meet regulatory, legal, and medical requirements.
• Conduct audits and analyses of labeling and UDI data for compliance and business needs.
• Manage UDI master data and IT workflows.
• Train end-users and resolve technical issues related to labeling systems.
• Perform label design work using tools like Loftware, Bartender, or enLabel.
• Troubleshoot and maintain label printers and support production requirements.
• Ensure compliance with quality and regulatory standards (QMS, EMS, RDA).

Qualifications:

• Bachelor's degree in Communications, Regulatory, Business, Mathematics, or related field.
• 5 7 years of experience in a regulated environment (manufacturing, quality, etc.).
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Strong communication, multitasking, and organizational skills.

Preferred:

• Experience with labeling design systems (Loftware, Bartender, enLabel).
• Skills in Adobe Illustrator, InDesign, and Photoshop.
• Familiarity with document control systems like Windchill.
• Experience in label printer qualifications (IQ, OQ, PQ) and troubleshooting.