Corrective and Preventive Action (CAPA) Coordinator

INW: Innovations in Nutrition + Wellness; Carrollton (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

INW: Innovations in Nutrition + Wellness is seeking a CAPA Program Coordinator to lead investigations, root cause analysis, and corrective actions in a regulated manufacturing environment. You will administer and maintain the CAPA system and documentation, review records from identification through closure, and monitor timelines while supporting audits and inspections.

2–5 years in Quality Assurance or CAPA management, a Bachelor’s degree (or equivalent), and strong problem solving, regulatory

Qualifications

• Bachelor’s degree preferred; equivalent experience considered.
• 2–5 years in Quality Assurance/Quality Systems/CAPA management.
• Experience in regulated industries (medical devices, pharma, biotech, food/manufacturing) preferred.
• Experience with electronic Quality Management Systems (eQMS) highly desirable.

Responsibilities

• Administer and maintain the CAPA system and documentation.
• Coordinate investigations for nonconformances, customer complaints, audit findings, deviations, and other quality events.
• Develop and track corrective and preventive actions with process owners.
• Verify CAPA effectiveness and monitor timelines.
• Support internal and supplier audits and regulatory inspections.
• Generate CAPA metrics and support continuous improvement.
• Train employees on CAPA procedures and documentation.

Skills

CAPA principles understanding

Quality management systems

Root cause analysis

Regulatory knowledge

Organizational & project mgmt

Education

Bachelor's degree preferred

Tools

eQMS

Job description

Job Details

• 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.

Description

• 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.