Job Description

Job Title: Labeling Design Representative

Location: Irvine, CA

Duration: 12 Months

Space Designation: Flexible (Onsite as needed)

Job Summary:
The Labeling Design Representative will process pre-designed changes using specialized labeling software, ensuring compliance with established standards. The role involves collaborating with cross-functional teams, executing complex labeling tasks, and driving process improvements in a regulated environment.

Responsibilities

• Execute detailed labeling changes, including illustrations, using SDL and Loftware solutions (65%).
• Evaluate risks, provide recommendations, and take necessary actions (10%).
• Identify and recommend process improvement opportunities and procedural updates (5%).
• Train and mentor other team members on labeling design processes (5%).
• Support tasks related to NCRs and CAPAs, ensuring resolution and compliance (5%).
• Collaborate with cross-functional teams to implement sustaining labeling changes (5%).
• Perform other incidental duties as required (5%).

Qualifications

Education & Experience

• Associate's Degree or equivalent with 4+ years of relevant experience OR
• High School Diploma with 6+ years of relevant experience.
• Experience in a medical or pharmaceutical FDA-regulated environment is preferred.

Technical Skills

• Proficiency in Adobe Suite (InDesign, Photoshop, Illustrator).
• Familiarity with Content Management Systems (CMS) and Loftware Spectrum is preferred.
• Strong knowledge of ECR and PDM processes.
• Proficiency in MS Office Suite.

Core Competencies

• Attention to detail and adherence to regulatory requirements.
• Excellent written and verbal communication skills.
• Strong organizational and time-management abilities.
• Ability to collaborate effectively in team-based environments.
• Passion for quality and process improvement.

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