Corrective and Preventive Action (CAPA) Coordinator
On-site · Carrollton, Texas, United States
Job Summary
CAPA Program Coordinator responsible for administering CAPA system and documentation, managing CAPA records from identification to closure, and ensuring compliance with procedures and FDA/regulatory requirements. Leads investigations for nonconformances, customer complaints, audits, deviations, and other quality events using methods such as 5 Whys, Ishikawa diagrams, Fault Tree Analysis, and FMEA. Collaborates with process owners to develop effective corrective and preventive action plans, verifies effectiveness, and tracks progress to deadlines. Supports audits (internal, customer, supplier, regulatory) and provides CAPA documentation during inspections. Generates CAPA metrics, analyzes quality data for recurring issues, and supports continuous improvement initiatives. Trains employees on CAPA procedures and offers guidance on investigation techniques and documentation requirements.
Required Qualifications
- Bachelor's degree preferred
- 2–5 years of experience in Quality Assurance, Quality Systems, CAPA management
- Experience in regulated industries such as medical devices, pharmaceuticals, biotechnology, food manufacturing, or manufacturing preferred
- Experience with electronic Quality Management Systems (eQMS) is highly desirable
- 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
Desired Qualifications
- Bachelor's degree preferred
- 2–5 years of experience in Quality Assurance, Quality Systems, CAPA management
- Experience in regulated industries (medical devices, pharmaceuticals, biotechnology, food manufacturing, or manufacturing) preferred
- Experience with electronic Quality Management Systems (eQMS) highly desirable
- 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
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