The Opportunity

This position works out of our Sturgis, MI location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active.

Millions of people around the world count on our leading brands including Similac, PediaSure, Pedialyte, Ensure, and Glucerna to help them get the nutrients they need to live their healthiest lives.

For over 70 years, Abbott’s Sturgis, Mich. , has been impacting its community while producing products that provide essential nutrition to millions of families around the world.

Working here, you’ll feel part of a family that is dedicated to making a difference and helping others.

What You’ll Work On

The CAPA Specialist progresses investigations through the CAPA system. Works closely with other functional areas with the use of investigational tools to determine the root cause of any nonconformity, ensures that CAPA plans address root causes, and ensures that corrective actions and preventative actions are implemented to facilitate the rapid, compliant, introduction of new / improved products, processes, and systems.

Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers and that required standards and / or procedural requirements are met.

Be an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct.

• Evaluates and progresses the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and / or deviations, as output from ADC’s Quality System.
• Facilitates the investigation process to ensure that root / potential causes are appropriate and implement effective actions to reduce the occurrence / recurrence of the nonconformance.
• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
• Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
• Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner;

and that viable corrective actions are identified and implemented to address any non-conformances.

Required Qualifications

• Associate's Degree or high school diploma with equivalent with 2 years CAPA work experience in manufacturing plant environment.
• Minimum 2 years’ experience in regulated, manufacturing environment.
• Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted.
• Good project management skills to deliver an effective service in a timely manner.
• Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.
• Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization.
• Able to work independently.

Preferred Qualifications

Knowledge of FDA Quality System Regulations

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Last updated : 2024-05-13