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Corrective Action Preventive Action Specialist

2 months ago


Tipp City, Ohio, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Job Title: Corrective Action Preventive Action Specialist

We are seeking a highly skilled Corrective Action Preventive Action Specialist to join our team in the Abbott Nutrition division. As a Corrective Action Preventive Action Specialist, you will be responsible for implementing and maintaining the effectiveness of the quality system, ensuring compliance with FDA, OSHA, and Abbott policies and procedures.

Key Responsibilities:
  • Implement and maintain the effectiveness of the quality system
  • Maintain the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits
  • Progress investigations through the CAPA system
  • Work closely with other functional areas to determine the root cause of any nonconformity and ensure that CAPA plans address root causes
  • Ensure that corrective actions and preventative actions are implemented to facilitate the rapid, compliant introduction of new/improved products, processes, and systems
  • 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
  • Evaluate and progress the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations
  • Facilitate the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance
  • Maintain the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits
  • Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner
  • Support a work environment that ensures team effectiveness by demonstrating full cross-functional team support that complies with Corporate and regulatory requirements
  • Support 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
Requirements:
  • Associates degree in a relevant field or high school diploma/GED with 2+ years experience in a high volume, regulated manufacturing environment
  • Able to apply strategic and quality logic and project management skills to investigation activities
  • 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:
  • Bachelor's degree in a relevant field
  • Experience in leading CAPA investigations
  • Experience with ABTRAQ or other quality management system
  • Project management experience
  • Extensive root cause analysis experience
  • Knowledge of FDA Quality System Regulations
About the Opportunity

This position works out of our Tipp City, OH 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.

Tipp City, Ohio, is one of Abbott's newest nutrition manufacturing facilities with technology that enhances production efficiency and product quality. Join us and you'll be part of a family that's dedicated to innovation and excellence and dedicated to nourishing millions of families around the world.

What You'll Work On

You'll be accountable for meeting our compliance standards including FDA, OSHA, and Abbott policies and procedures.

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity and Military/Veteran friendly Employer, committed to employee diversity.

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