CAPA Coordinator M/F (30634)

Laboratoire Guerbet•Raleigh, IL

About The Position

The CAPA Coordinator operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The position is responsible for the administration, coordination, and oversight of the site’s Corrective and Preventive Action (CAPA) program in accordance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and internal quality system standards. The CAPA Coordinator oversees the post–root cause phase of the CAPA process, ensuring that corrective and preventive actions are appropriately documented, effectively implemented, accurately tracked, and verified for effectiveness. The role supports cross‑functional collaboration to execute actions resulting from quality events, deviations, and audits, and plays a key role in supporting inspection readiness and driving continuous improvement at the drug product manufacturing site.

Requirements

Minimum of 3 to 6 years of experience in a pharmaceutical, biotech, or regulated GMP environment.
Working knowledge of CAPA requirements under FDA and international GMP regulations.
Experience with investigations, root cause analysis, and quality systems documentation.
Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field (or equivalent experience).
Strong proficiency in computer systems, including advanced working knowledge of Microsoft Word, Excel, and Outlook.

Responsibilities

Coordinate, administer, and maintain the site CAPA system in compliance with GMP and regulatory requirements.
Initiate, track, and manage CAPAs arising from completed investigations, complaints, audit findings, OOS results, trend analyses and improvements.
Ensure CAPAs are clearly defined, risk-based, appropriately scoped, and aligned with established root cause conclusions to address identified issues effectively.
Monitor CAPA execution and timelines, proactively manage due dates; escalate overdue or at-risk actions, and ensure timely and compliant closure.
Coordinate and oversee CAPA effectiveness checks to confirm that implemented actions are effective, sustainable, and prevent recurrence.
Analyze and trend CAPA and related quality system data to identify recurring issues, systemic risks, and opportunities for improvement.
Develop, compile and present CAPA metrics, trends and status reports to support Quality Management Review and site leadership oversight.
Maintain accurate, complete and inspection ready CAPA documentation within electronic quality management or controlled documentation systems.
Support internal, customer, and regulatory audits and inspections by providing CAPA documentation, status updates and responses as required.
Provide guidance, coaching and training to cross functional stakeholders on CAPA processes, root cause analysis, quality system requirements and effectiveness expectations.
Contribute to continuous improvement initiatives aimed at strengthening the effectiveness of the site Quality Management System.
Perform other duties as assigned by management.