CAPA Specialist, Analytical Lab - Sturgis, MI Plant

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 115,000 colleagues serve people in more than 160 countries.

Job Title

CAPA Specialist, Analytical Lab

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

• Progresses investigations through the CAPA system in support of non-CAPA organizations.

• Works closely with other functional areas with the use of investigational tools, to determine the root cause of any nonconformity, ensure that CAPA plans address root causes, and ensure that CA/PAs 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. 

• Is 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 progress the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from the division’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.

• Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.

• Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.

• Supports the attainment of division goals and objectives.

• Accountable to the Quality Organization for achieving mutually agreed upon objectives.

• 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.

• The CAPA System is a key inspection focus of worldwide regulators and auditors.

• The system must be usable, simple, sustainable and well maintained.

• Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls.

• Decisions and recommendations made by this position impact quality decisions for marketed products and the division’s Quality System.

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

Required Qualifications

• High School Diploma / GED AND Associate's Degree OR 2+ years' CAPA work experience in a manufacturing plant environment.

• 2+ years’ experience in a 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

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

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.

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The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.]]><