Corrective and Preventive Action (CAPA) Coordinator - #304094

INW: Innovations in Nutrition + Wellness


Date: 7 hours ago
City: Carrollton, TX
Contract type: Full time
Job Details

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.

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