CAPA Coordinator II - Sturgis, MI Plant at Abbott Laboratories

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 Title: CAPA Coordinator II

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 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

• Lead cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CAPAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.
• Ensure that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met. 
• Lead 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, as output from ADC’s Quality System.
• Is a subject matter expert on investigation and root cause analysis techniques 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 within the area.
• Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
• Produce trending metrics and reports to identify, prioritize and manage further actions, as may be required.
• Provide leadership for the initiation of improvement activities associated with identified trends.
• Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
• Interact across multiple functional areas including operations, R&D, Marketing, Supply Chain, Quality and Regulatory.
• Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for non-conformances, potential non-conformances, CAPAs, deviations, and/or complaint investigations.

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

Required Qualifications

• Bachelors Degree or equivalent combination of education and work experience
• 4+ years’ experience working in a regulated, manufacturing environment.
• Good working knowledge of investigational and Root Cause Analysis Techniques.
• Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.
• Good technical writing and oral communication skills are required to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization.
• Must be able to work independently

Preferred Qualifications

• Good working knowledge of FDA Quality System Regulations (QSR) and/or ISO13485

Apply Now 

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com 

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 Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.