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Summary
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.
- 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.
- 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.
- 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
- 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.
- Train employees regarding CAPA procedures and quality system requirements.
- Provide guidance to CAPA owners regarding investigation techniques and documentation requirements.
Education- Bachelor's degree preferred. Equivalent combination of education and experience considered.
- 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.
- 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.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor. -
Job 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.
- 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.
- 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.
- 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
- 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.
- Train employees regarding CAPA procedures and quality system requirements.
- Provide guidance to CAPA owners regarding investigation techniques and documentation requirements.
Education- Bachelor's degree preferred. Equivalent combination of education and experience considered.
- 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.
- 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.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor. -
ABOUT THE COMPANY
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