Corrective and Preventive Action Coordinator

Our client is seeking a detail-oriented CAPA / Quality Systems Specialist to support the administration and continuous improvement of its Corrective and Preventive Action (CAPA) program.

This position will coordinate investigations, facilitate root cause analysis, track corrective and preventive actions and help ensure quality activities are completed in accordance with established procedures and applicable regulatory requirements.

The ideal candidate brings hands-on Quality Assurance or Quality Systems experience in a regulated environment, strong problem-solving skills and the ability to collaborate effectively with cross-functional teams.

Key Responsibilities

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 applicable regulatory requirements
• Monitor CAPA timelines, follow up on outstanding actions and escalate overdue items as needed
• Maintain accurate and complete CAPA records within the Quality Management System

Investigations & Root Cause Analysis

• Coordinate investigations involving nonconformances, customer complaints, audit findings, deviations and other quality events
• Facilitate root cause analysis using established methodologies such as 5 Whys, Fishbone (Ishikawa) Diagrams, Fault Tree Analysis and FMEA
• Partner with cross-functional teams to identify contributing factors and determine appropriate root causes
• Ensure investigations are thorough, well documented and supported by objective evidence

Corrective & Preventive Actions

• Collaborate with process owners to develop effective corrective and preventive action plans
• Evaluate proposed actions to ensure they address identified root causes and reduce the risk of recurrence
• Track implementation progress and ensure actions are completed within established deadlines
• Provide guidance to CAPA owners regarding investigation and documentation requirements

Effectiveness Verification

• Coordinate effectiveness checks to verify corrective and preventive actions have successfully addressed identified issues
• Review quality data, performance metrics and supporting evidence to determine CAPA effectiveness
• Recommend additional actions when established effectiveness criteria are not met
• Document effectiveness results in accordance with Quality System requirements

Compliance & Audit Support

• Support internal, customer, supplier and regulatory audits
• Prepare and provide CAPA documentation, records and status updates during audits and inspections
• Help maintain compliance with applicable regulatory requirements and standards, including FDA 21 CFR Parts 111, 117 and 114
• Generate CAPA metrics, trend reports and quality data for management review
• Analyze quality trends to identify recurring issues, systemic risks and opportunities for improvement
• Support continuous improvement initiatives across the organization
• Assist in identifying opportunities to strengthen CAPA processes and overall Quality System effectiveness

Training

• Train employees on CAPA procedures and applicable Quality System requirements
• Provide guidance to CAPA owners on investigation techniques, root cause analysis and documentation expectations
• Promote consistent application of CAPA requirements throughout the organization

Qualifications

Education

• Bachelor's degree preferred
• An equivalent combination of education, training and relevant professional experience will be considered

Experience

• 2–5 years of experience in Quality Assurance, Quality Systems, CAPA management or a related quality function
• Experience working in a regulated industry such as medical devices, pharmaceuticals, biotechnology, food manufacturing or other regulated manufacturing environments preferred
• Experience working with an electronic Quality Management System (eQMS) is highly desirable
• Hands-on experience with investigations, root cause analysis and corrective action processes preferred

Knowledge & Skills

• Strong understanding of CAPA principles and Quality Management Systems
• Working knowledge of root cause analysis and structured problem-solving methodologies
• Familiarity with applicable regulatory requirements and industry standards
• Strong analytical and critical-thinking skills
• Excellent organizational and project management abilities
• Strong written and verbal communication skills
• Ability to manage multiple CAPAs, investigations and deadlines simultaneously
• Ability to collaborate effectively with employees and process owners across multiple functions
• Strong attention to detail with an emphasis on accurate, compliant documentation