Summary/Objective: The QA CAPA Coordinator is responsible for managing, tracking, and ensuring the timely and effective execution of Corrective and Preventive Actions (CAPAs) within the organization. This role plays a critical part in maintaining compliance with internal quality standards and external regulatory requirements by overseeing the full CAPA lifecycle—from initiation and investigation to implementation and verification of effectiveness.

 

Specific Responsibilities and Essential Functions:

CAPA Management:

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    Coordinate the initiation, documentation, and closure of CAPA records.

    
    
  
  
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    Ensure CAPAs are completed within defined timelines and meet quality and regulatory standards.

    
    
  
  
  
  

Investigation Support:

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    Assist all departments in operations with root cause analysis and problem-solving activities to identify the underlying causes of non-conformances with the use of 5 WHY methodology; 8D method and or any tool to ensure root cause is determined.

    
    
  
  
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    Collaborate with cross-functional teams to develop effective corrective and preventive action plans.

    
    
  
  
  
  

Verification & Effectiveness Checks:

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    Monitor and verify the implementation and effectiveness of CAPAs.

    
    
  
  
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    Ensure that actions taken adequately address the root cause and prevent recurrence throughout all Shrink Sleeve operations (BTN; NC; FSPM)

    
    
  
  
  
  

Documentation & Reporting:

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    Maintain accurate and complete CAPA records in the quality management system (QMS) through Integrify

    
    
  
  
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    Generate regular reports and metrics on CAPA status, trends, and performance for management review on a weekly and monthly basis.

    
    
  
  
  
  

Audit Readiness:

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    Support internal and external audits by providing CAPA documentation and status updates.

    
    
  
  
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    Train departments on root cause and corrective action methodologies( 5 WHY or 8 D) as needed.

    
    
  
  
  
  

Process Improvement:

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    Identify opportunities to improve CAPA processes and overall quality system performance across all operational sites ( BTN; NC and FSPM)

    
    
  
  
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    Report on completion of cross operational CAPA review weekly and monthly to Site QA Leader and or Quality Director.

    
    
  
  
  
  

Other Duties:

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    Perform additional responsibilities as assigned to support the success of the quality department and the organization.

    
    
  
  
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    Be the back up for QA CAR Coordinator and P&G Engineer as needed