CAPA Specialist

Responsibilities

• Lead and execute investigations related to non-conformance and manufacturing deviations to determine root cause, product impact, and risk.
• Generate and maintain CAPA documentation, including investigation reports for routine and non-routine manufacturing issues.
• Define and implement appropriate corrective and preventive actions to ensure sustainable solutions.
• Collaborate cross-functionally with Quality, Manufacturing, Engineering, and Procurement teams to drive alignment and timely resolution.
• Track and trend CAPA data to identify recurring issues and support continuous improvement initiatives.
• Support the development, revision, and implementation of standard operating procedures (SOPs) and related quality documentation.
• Ensure all activities meet compliance standards including FDA, OSHA, and internal Abbott policies.

Requirements

• Associate’s degree.
• Minimum of 2 years of CAPA experience within a manufacturing environment.
• At least 2 years of experience working in a regulated environment (e.g., FDA, cGMP).

Preferred Qualifications

• Bachelor’s degree.

Benefits

• Career development opportunities within a global international company.
• Eligibility for free medical coverage through the Health Investment Plan (HIP) PPO plan.
• Excellent retirement savings plan with high employer contributions.
• Tuition reimbursement and various education benefits including the FreeU program.

About the Company

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, including diagnostics, medical devices, nutritionals, and branded generic medicines. With over 115,000 colleagues serving people in more than 160 countries, we are dedicated to advancing innovative technologies that enhance the health and well-being of millions worldwide.