CAPA Process Analyst

Job Description

The CAPA Process Analyst II is responsible for leading investigations of quality events, nonconformances, deviations, and complaints within a regulated environment. This role supports the Corrective and Preventive Action (CAPA) process by collaborating with cross-functional teams, performing root cause analysis, maintaining compliant documentation, and ensuring corrective actions are implemented effectively. The position requires strong experience with Quality Management Systems (QMS), technical writing, and regulatory compliance to maintain audit readiness and continuous quality improvement.

Key Skills

• Corrective and Preventive Action (CAPA)
• Quality Management System (QMS)
• Nonconformance investigations
• Root Cause Analysis (RCA)
• Quality event investigations
• Deviation management
• Complaint investigations
• Cross-functional collaboration
• Technical writing
• Regulatory compliance
• Audit readiness
• Documentation management
• Quality systems
• Continuous improvement
• Risk assessment
• Communication skills

Required Qualifications

• Bachelor's degree in Life Sciences
• 4+ years of experience in regulated environments
• Experience with CAPA processes
• Experience in pharmaceutical, medical device, or laboratory environments
• Experience working with QMS platforms
• Strong written and verbal communication skills
• Excellent technical writing skills
• Ability to prioritize workload and manage multiple tasks

Additional Skills

• ASQ Certified Quality Auditor (CQA)
• Project management experience
• Knowledge of CAP regulations
• Knowledge of NLCP regulations
• Knowledge of FDA regulations
• Experience using Agile
• Ability to identify quality trends and implement improvements
• Experience supporting internal and external quality audits