CAPA Specialist

The Opportunity

This position works out of our Altavista, VA 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.

Altavista, Va., is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you feel like you’re part of a family that works together to make a difference and help nourish millions of families around the world.

What You’ll Work On

• 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.

Required Qualifications

• Associates Degree or an equivalent combination of education and work experience.

• Minimum of two (2) years of experience working in a regulated environment or experience performing investigations. 

• 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

• Bachelor’s Degree

• 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

The base pay for this position is

In specific locations, the pay range may vary from the range posted.