Specialist II, Labeling

Abbott Laboratories - Sylmar, CA (30+ days ago)4.1


At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Job Summary:
The Labeling Specialist II is responsible for the development of medical device labeling for the Cardiovascular Division by coordinating across functions as well as multiple US and international sites.

Job Duties:
Creates and modifies labeling for product labels, cartons and other related materials ensuring that they meet all medical, legal and regulatory requirements for medical devices following the established design format, labeling style guidelines and branding guidelines.
Designs product labeling considering such factors as product identification, worldwide requirements, sales appeal, aesthetic quality, printing and production techniques
Creates and manages labeling change requests within the document management system
Manages multiple concurrent deadlines
Maintains knowledge of new developments in packaging and labeling technologies.
Supports all initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Works with other functions to identify and resolve labeling inconsistencies with labeling material and requirements and to meet project objectives.
Labeling representative on cross functional team collecting labeling content and translating it into functional label layouts utilizing labeling software. Provides direction on label content and process requirements to cross functional members. May work on both commercialized and new product labeling projects.
May identify and support the implementation of packaging/labeling process improvement projects.
May own and develop department level procedures and work instructions.
Works on projects that are medium in scope/medium profile.
May assist in establishing schedule/deadline parameters for assigned tasks.
Exhibits leadership in meetings, problem solving, driving projects and issue resolution.
Monitor for regional changes that have an impact on labeling
Be able to navigate labeling software, understand intricacies to produce worldwide labeling. Be able understand functionality such that you can test releases and upgrades. Participate in testing plans and requirements gathering.
Possess knowledge of therapy types and the features and how they relate to labeling content. Understand the impact on labeling if there are changes to those definitions. Ensure you are capturing the labeling content for that product correctly
Knowledge of labeling workflow from creation to obsolescence
Be able to work on internal and external audit-related tasks/projects.
Gather metrics data and participate in issue and remediation plan as needed.
Works across functional teams to collect, aggregate, match, consolidate, and confirm data and business elements as it is entered into the application.
Monitors to ensure data meets Unique Device Identifier (UDI) and FDA requirements for medical devices and follows the prescribed formats established in the regulations and internal work instructions.
Facilitates collection of data from various sources and functions and process of collating that data into a coherent collection.
Facilitates review and approval of the data, as required by each project.
Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications:
Bachelor’s degree or a minimum of 4 years experience working with product labeling, design dossiers, quality systems and/or regulatory labeling
Experience developing artwork and graphics for FDA regulated medical products and creation and management of change requests in a an electronic environment preferred
Experience with labeling software
Experience utilizing computer-aided design equipment and/or graphic tools such as CAD Adobe Illustrator/Photoshop and other related software
Experience ensuring quality is met with all contributions and deliverables
Possess an understanding of process flow diagrams
Ability to drive, organize, contribute and deliver on multiple projects
Ability to communicate effectively with internal and external customers and team members
Knowledge of FDA, GMP, and ISO guidelines
Requires ability to be innovative, resourceful, and work with minimal direction
Requires excellent organization, problem solving, and communication skills and the ability to work effectively with cross-functional teams