CAPA Specialist

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.

We are seeking a highly skilled CAPA Specialist to join our team at Abbott Laboratories. As a CAPA Specialist, you will be responsible for progressing investigations through the CAPA system in support of non-CAPA organizations. This role requires strong project management skills, attention to detail, and effective communication skills to ensure accurate and timely completion of investigations.

• 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 within the area.
• 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.

• 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.

• Bachelor's degree
• Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 is preferred.

Abbott Laboratories is an Equal Opportunity Employer and a Military/Veteran friendly Employer, committed to employee diversity. We offer a comprehensive benefits package, including medical, dental, vision, wellness and occupational health programs, and a 401(k) retirement savings plan with a generous company match.

Join our team and be part of a company that is recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.