The Opportunity

This position is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives.

As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers.

Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we’re committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

As a Labeling Process Improvement Specialist, you will be responsible for managing Artwork & Labeling Development departmental processes and maintains the continuous improvement philosophy to meet internal and external initiatives & requirements at Abbott Diabetes Care.

This is an onsite opportunity in Alameda, CA.

What You'll Do

• Maintains labeling processes and documentation to meet QMS, Global Regulations, and Compliance requirements.
• Under general direction, establishes, develops and implements labeling process improvements with the most optimal effectiveness.

Consults with internal / external groups to align solutions that improve processes and techniques.

• Perform labeling assessments and charter projects that improve processes to support business and department initiatives.
• Leads the development of labeling training materials and tools to support the implementation of projects.
• Author / revise labeling documentation (e.g. Procedures, SOP(s), Specifications, etc.) to meet the Division’s needs
• Creates and modifies documentation supporting process and requirements for product labels, cartons, and other related materials ensuring that they meet all medical, legal, and regulatory requirements for medical devices / in vitro diagnostic devices (IVDs) following the established creative design format and brand guidelines
• Complies with U.S. Food and Drug Administration (FDA) regulations, other global regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Adapts precedent and may make significant departures from traditional approaches to develop innovative solutions.
• Participates in external organizations, conferences and seminars to keep current with industry best practices of industry developments in packaging artwork, labeling technologies and regulations.
• Contributes to strategic planning for compliance when needed.
• Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
• Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
• Plans and organizes project assignments of substantial variety and complexity.
• Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
• Initiates or maintains schedule for projects and project milestones. Establishes priorities of individual or project assignments.

Selects methods and techniques to lead a project to completion.

• Strong organizational and human relations skills. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Strong written and oral communication skills and ability to present to management and to extended teams.

Experience You'll Bring

Required

• Bachelors Degree in engineering, science, or technical related field.
• Minimum 5 years of experience in design / process verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing.

Last updated : 2024-05-18