Corrective and Preventive Action (CAPA) Coordinator

CAPA Program Coordination

• Administer and maintain the CAPA system and associated documentation.
• Review, initiate, and track CAPA records from identification through closure.
• Ensure CAPAs are processed in accordance with company procedures and regulatory requirements.
• Monitor CAPA timelines and escalate overdue actions as necessary.

Investigation and Root Cause Analysis

• Coordinate investigations related to nonconformances, customer complaints, audit findings, deviations, and other quality events.
• Facilitate root cause analysis using methodologies such as:
• 5 Whys
• Fishbone (Ishikawa) Diagrams
• Fault Tree Analysis
• FMEA
• Ensure investigations are thorough, documented, and supported by objective evidence.

Corrective and Preventive Actions

• Collaborate with process owners to develop effective corrective and preventive action plans.
• Verify actions address identified root causes and mitigate recurrence risks.
• Track implementation progress and ensure completion within established deadlines.

Effectiveness Verification

• Coordinate effectiveness checks to confirm CAPAs have resolved identified issues.
• Review data and performance metrics to determine CAPA effectiveness.
• Recommend additional actions when effectiveness criteria are not met.

Compliance and Audits

• Support internal, customer, supplier, and regulatory audits.
• Provide CAPA documentation and status updates during audits and inspections.
• Ensure compliance with applicable standards such as FDA 21 CFR Part 111/117/114

Reporting and Continuous Improvement

• Generate CAPA metrics and trend reports for management review.
• Analyze quality data to identify recurring issues and improvement opportunities.
• Support continuous improvement initiatives across the organization.

Training

• Train employees regarding CAPA procedures and quality system requirements.
• Provide guidance to CAPA owners regarding investigation techniques and documentation requirements.

Qualifications

Education

• Bachelor's degree preferred. Equivalent combination of education and experience considered.

Experience

• 2–5 years of experience in Quality Assurance, Quality Systems, CAPA management
• Experience in a regulated industry such as medical devices, pharmaceuticals, biotechnology, food manufacturing, or manufacturing preferred.
• Experience with electronic Quality Management Systems (eQMS) is highly desirable.

Knowledge and Skills

• Strong understanding of CAPA principles and quality management systems.
• Knowledge of root cause analysis and problem-solving methodologies.
• Familiarity with regulatory requirements and industry standards.
• Excellent organizational and project management skills.