Lead Labeling & Kit Design Associate IV

Abbott Laboratories; Madison (WI); Hybrid; USD 61,000 - 123,000; Full time

Job summary

Abbott Laboratories in Madison, Wisconsin is seeking a Design Transfer Associate IV to support labeling and kitting implementation into production, including development, documentation, validation, and process improvements. This on-site role requires four days per week in the facility, with one remote day allowed, collaboration across Manufacturing Sciences, Quality, Regulatory, and Supply Chain.

You will train production staff, lead or support process changes, and help ensure compliance with

Qualifications

• Bachelor's degree in biology, chemistry, or related life science.
• 3+ years operating in a heavily regulated biotech environment (FDA GMP/ISO 13485) for IVD/ RUO.
• 2+ years using Agile or other electronic Quality Management Systems (eQMS) for documentation or change control implementation.
• Proficient in Microsoft Office.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Assist in design transfer and continuous improvement for labeling and kitting.
• Develop, document, validate, and implement labeling and kitting processes.
• Support training and transfer of processes to production operators.
• Collaborate with QA, Regulatory, and Supply Chain on labeling requirements.
• Lead or support risk assessments and PFMEA.
• Travel between Madison locations as needed.

Skills

Agile

eQMS

Microsoft Office

Education

Bachelor's degree in biology

Tools

NiceLabel

BarTender

Adobe Illustrator

Job description

Abbott Laboratories in Madison, Wisconsin is seeking a Design Transfer Associate IV to support labeling and kitting implementation into production, including development, documentation, validation, and process improvements. This on-site role requires four days per week in the facility, with one remote day allowed, collaboration across Manufacturing Sciences, Quality, Regulatory, and Supply Chain.

You will train production staff, lead or support process changes, and help ensure compliance with