Quality Specialist - CAPA

Responsibilities

• Own the Nonconformance and Corrective and Preventive Action (CAPA) system
• Assist in the initiation, processing, and completion of QI/CAPA records within the electronic system
• Ensure record owners are assigned and that timely responses and approvals are provided in alignment with quality goals
• Assess and document the impact of Nonconformance events to determine investigation requirements
• Lead meetings and communications for QI/CAPA updates, including chairing the site CAPA Review board
• Collate metrics and provide regular reporting in accordance with established procedures
• Support the delivery and oversight of the CAPA training program
• Provide subject matter expertise and support during audits and inspections
• Lead or contribute to continuous improvement initiatives and projects

Requirements

• Degree or equivalent, preferably in a life science subject area
• Experience working within a regulated industry
• Expertise in a range of root cause investigation tools and techniques
• Competence with QI/CAPA processes
• Proficiency with MS Office (Word, Excel, and PowerPoint)

Preferred Qualifications

• Practical understanding of immunoassay and clinical chemistry testing or In-vitro Diagnostics
• Experience with Enterprise Resource Planning (ERP) systems
• Experience with Electronic Document Management Systems (EDMS)
• Experience with QI/CAPA systems, such as Agile
• Experience with Complaint Investigation systems, such as Helix

About the Company

Abbott is a global healthcare leader that has been helping people reach their potential for more than 135 years. With a network serving customers in over 160 countries, we create innovative solutions across diagnostics, medical devices, nutrition, and branded generic medicines to help people live their best lives through better health.