MAIN PURPOSE OF ROLE
The Labeling and Packaging designer is primarly responsible to oversee the labeling and packaging graphic design activities and projects. This role develops, modifies, maintains, and secures that product packaging and labeling meets required global regulations and requirements mandated by Abbott.
The Labeling and Packaging designer creates and consolidates redlines for artwork and specifications, prepares and/or manages translations, creates and/or revises labeling artwork using graphic design software, performs proofreading, manages change control, and performs data entry (creation, updating, and maintenance of artwork files in the electronic documentation control system). The Labeling and Packaging designer works closely with Abbott stakeholders and vendors to ensure the labeling materials are built to required standards and will not have any technical problems once finalized.
MAIN RESPONSIBILITIES
- Create technically accurate, consolidated redline(s), that reflect all changes to packaging and labeling artwork and requiried specifications.
- Collaborate with Abbott cross-functional teams to resolve redline issues.
- Ensure packaging and labeling redlines are compliant with drawings, die lines, blueprints, templates, and Abbott Corporate Identity guidelines.
- Prepare and manage language translations including preparing translation inputs, obtaining translations, facilitating reviews, and obtaining and managing approvals.
- Perform technical review of packaging and labeling specifications to ensure compliance to formatting, manufacturing and printing requirements.
- Utilize/develop existing templates or artwork to create or revise technically accurate packaging and labeling artwork based on redlines, drawings/blueprints, regulatory requirements, and printing/manufacturing requirements.
- Perform technical reviews of packaging and labeling artwork and troubleshoot issues while meeting regulatory, quality, manufacturing and printing requirements.
- Assemble packaging and labeling files and documents to facilitate artwork creation.
- Obtain draft packaging and labeling and perform technical review to ensure accuracy and compliance to redlines, drawings, die lines, blueprints, templates, and Corporate Identity.
- Perform quality proofreading.
- Obtain approval of packaging and labeling specification content and final artwork utilizing electronic workflow in document management system.
- Perform prepress activities to prepare and send packaging and labeling artwork to print suppliers. Act as technical liaison with print suppliers and manufacturing to resolve printing issues.
- Obtain packaging and label material part numbers and perform product data and document management entry, configuration, and processing in document management system, including managing the chnage control process.
- Closely follow defined processes and documentation to ensure highest quality and compliance to cGMP and regulatory requirements (e.g. WHO, IVDR, etc.).
- Assist SCM in the creation/change of Bill of Materials and obsolescence of packaging and labeling materials.
- Aid in training internal and external personnel on packaging and labeling related processes and systems.
- Support team project initiatives, including cost reduction opportunities.
- Ensure packaging and labeling project deliverables are closely monitored to successfully meet project milestones.
- Perform other graphics desing activities (e.g. business posters, banners, etc.) as assigned.
QUALIFICATIONS
Education
Education Level
Major/Field of Study
Bachelors Degree (± 16 years)
BA in Graphic Design, BS in Packaging (Design), and printing or equivalent experience.
Experience/Background
Experience
Experience Details
Minimum 3-5 years relevant graphics/ compliance packaging and labeling experience in a regulated pharmaceutical, medical device or consumer industry with extensive mechanical file preparation or production art background
- MUST be highly proficient in Adobe Creative Suite, with an emphasis in Illustrator and InDesign)
- Must be proficient in Microsoft Word, Excel, PowerPoint, SharePoint and willing to learn new programs specific to business needs and processes
- Knowledge of product packagign and labeling regulations / compliance
- Knowledge and understanding of product development process, graphic design/layout process / various packaging / label production phases and printing processes / technologies / materials and equipment
- Knowledge and experience of printing and color management tools/software
- Expertise in project management and change management.
- Ability to effectively manage and process documents in a document management system.
- Ability to work independently and meet deadlines.
- Ability to handle multiple demands, shifting priorities, crises and rapid change environment.
- Excellent organizational skills, strong reporting and analytics capabilities
- Excellent communication (verbal and written), interpersonal skills with the ability to communicate/ work effectively with cross-functional teams in a global environment
- Excellent presentation skills and ability to effectively facilitate team meetings and/or large-scale project teams meetings.
- Experience in medical device labeling, including Instructions For Use (IFUs), understanding of GMP requirements working in a regulated environment.
Language Proficiency
Japanese - fluent
English - fluent
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