What are the responsibilities and job description for the Corrective and Preventive Action (CAPA) Coordinator position at INW Manufacturing, LLC?
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.