Corrective and Preventive Action (CAPA) Coordinator

Job Details

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 11, 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.