CAPA Specialist – Corrective and Preventive Action Specialist - Day Shift - Casa Grande, AZ

Abbott 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. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

CAPA Specialist – Corrective and Preventive Action Specialist

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. 
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. 

The Opportunity

This position works out of our Casa Grande, Arizona 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.

Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to innovation and excellence. But we’re more than just a company, we’re a family. Working here you’ll be part of a family that works together to make a difference and enhance the lives of millions worldwide.

What You’ll Work On

• Generate exception/CAPA documentation such as non- conformance reports and investigation reports required at the site for routine and non-routine manufacturing issues.
• Independently investigate all aspects of the exception event and determine the root cause, product impact, risk impact, corrections, and corrective/preventive actions.
• Utilize device design history files, specifications, test methods, factory data, field data, or quality policies as necessary to support decisions.
• Coordinate/facilitate meetings and/or communicate cross-functionally to develop solid solutions to CAPA activities.
• Work with Quality, Technical Operations, Manufacturing, Engineering, or purchasing as needed to recommend/document appropriate corrections, corrective/preventive actions based on facts obtained during base CAPA investigations.
• Concurrently manage multiple CAPA projects and tasks, ensuring timely completion.
• Track and trend CAPA related information, as appropriate, to meet compliance requirements.
• Be key contributor of CAPA team in identifying, developing, and implementing process or product improvements.
• Support the creation, implementation and modification of product and process related documents including Operating Procedures and other related documents. 
• Ensure that all CAPA documents are written in compliance to Division policy and site procedures. 
• Document and investigate route and non-routine manufacturing issues independently or in collaborate with subject matter experts to develop robust CAPA solutions. 
• Concurrently manage multiple CAPA projects and tasks, ensuring timely completion. 
• Be key contributor to identifying and/or implementing CAPA process improvements. 
• Position is accountable for strict compliance to cGMP as it relates to CAPA documentation accuracy, decision accuracy, process compliance, process efficiency, and timeliness. 

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

Required Qualifications

• Bachelors Degree
• CAPA work experience in manufacturing plant environment
• Minimum 2 years experience in regulated, manufacturing environment

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and t