QA CAPA Coordinator (39056)

AMERICAN FUJI SEAL•Bardstown, KY

About The Position

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: Coordinate the initiation, documentation, and closure of CAPA records. Ensure CAPAs are completed within defined timelines and meet quality and regulatory standards. Investigation Support: 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. Collaborate with cross-functional teams to develop effective corrective and preventive action plans. Verification & Effectiveness Checks: Monitor and verify the implementation and effectiveness of CAPAs. Ensure that actions taken adequately address the root cause and prevent recurrence throughout all Shrink Sleeve operations (BTN; NC; FSPM) Documentation & Reporting: Maintain accurate and complete CAPA records in the quality management system (QMS) through Integrify Generate regular reports and metrics on CAPA status, trends, and performance for management review on a weekly and monthly basis. Audit Readiness: Support internal and external audits by providing CAPA documentation and status updates. Train departments on root cause and corrective action methodologies( 5 WHY or 8 D) as needed. Process Improvement: Identify opportunities to improve CAPA processes and overall quality system performance across all operational sites ( BTN; NC and FSPM) Report on completion of cross operational CAPA review weekly and monthly to Site QA Leader and or Quality Director. Other Duties: Perform additional responsibilities as assigned to support the success of the quality department and the organization. Be the back up for QA CAR Coordinator and P&G Engineer as needed Competencies and Qualifications: Accountability: Consistently meets deadlines and delivers high-quality, accurate work with minimal oversight. Maintains reliable attendance, reports to work on time, and returns promptly from breaks. Proactively communicates availability and keeps others informed of schedule-related concerns. Communication: Communicates clearly and respectfully through both verbal and written means. Actively listens, asks clarifying questions, and seeks assistance when necessary. Contributes meaningfully to team discussions and meetings. Customer Focus: Anticipates and addresses internal and external customer needs with professionalism and care. Builds respectful relationships while providing timely, informed, and appropriate solutions. Operates with a customer-first mindset, making decisions that align with organizational values and expectations. Execution: Demonstrates initiative, focus, and adaptability in achieving goals and meeting quality standards. Responds effectively to shifting priorities and collaborates with other departments as needed. Utilizes time and resources efficiently to ensure timely, high-quality results. Innovation: Contributes ideas, embraces feedback, and stays informed about industry trends and competitive opportunities. Demonstrates a willingness to embrace change, experiment, and pursue continuous improvement. Shares innovative ideas that foster team and organizational growth. Ownership: Takes responsibility for decisions, outcomes, and continuous improvement. Proactively solves problems, enhances processes, and communicates progress to stakeholders. Exercises autonomy, inspires commitment in others, and supports shared team goals. Role Proficiency: Demonstrates a solid understanding of the industry, role-specific responsibilities, and company practices. Quickly acquires the technical skills and tools essential for success. Applies job-specific knowledge effectively and stays current with evolving needs. Safety and Compliance: Consistently exhibits a “safety first” mindset. Prioritizes safety and follows all security and well-being standards. Understands and maintains company compliance policies and ethical standards. Leads by example to promote a safe, transparent, and compliant work environment. Teamwork: Collaborates effectively by integrating diverse perspectives and skills. Actively listens, shares knowledge, and supports team goals. Addresses conflicts constructively while maintaining a respectful and inclusive team environment. Education and Experience: Bachelor’s degree preferred with 3-5 years’ experience in a manufacturing environment. Proficient in Microsoft Word and Excel Diverse ability to understand manufacturing processes and communicate that throughout the organization Must be able to calculate, and read millimeter rulers, calipers, and scales Physical Demands: Ability to stand for long periods Able to move and lift-up to 50 lbs Able to reach and bend Travel Required: Availability to perform domestic and international travel as required – potentially not to exceed15% Other Duties: Please note that this job description is not designed to cover or contain a comprehensive listing of the activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

Requirements

Accountability: Consistently meets deadlines and delivers high-quality, accurate work with minimal oversight. Maintains reliable attendance, reports to work on time, and returns promptly from breaks. Proactively communicates availability and keeps others informed of schedule-related concerns.
Communication: Communicates clearly and respectfully through both verbal and written means. Actively listens, asks clarifying questions, and seeks assistance when necessary. Contributes meaningfully to team discussions and meetings.
Customer Focus: Anticipates and addresses internal and external customer needs with professionalism and care. Builds respectful relationships while providing timely, informed, and appropriate solutions. Operates with a customer-first mindset, making decisions that align with organizational values and expectations.
Execution: Demonstrates initiative, focus, and adaptability in achieving goals and meeting quality standards. Responds effectively to shifting priorities and collaborates with other departments as needed. Utilizes time and resources efficiently to ensure timely, high-quality results.
Innovation: Contributes ideas, embraces feedback, and stays informed about industry trends and competitive opportunities. Demonstrates a willingness to embrace change, experiment, and pursue continuous improvement. Shares innovative ideas that foster team and organizational growth.
Ownership: Takes responsibility for decisions, outcomes, and continuous improvement. Proactively solves problems, enhances processes, and communicates progress to stakeholders. Exercises autonomy, inspires commitment in others, and supports shared team goals.
Role Proficiency: Demonstrates a solid understanding of the industry, role-specific responsibilities, and company practices. Quickly acquires the technical skills and tools essential for success. Applies job-specific knowledge effectively and stays current with evolving needs.
Safety and Compliance: Consistently exhibits a “safety first” mindset. Prioritizes safety and follows all security and well-being standards. Understands and maintains company compliance policies and ethical standards. Leads by example to promote a safe, transparent, and compliant work environment.
Teamwork: Collaborates effectively by integrating diverse perspectives and skills. Actively listens, shares knowledge, and supports team goals. Addresses conflicts constructively while maintaining a respectful and inclusive team environment.
3-5 years’ experience in a manufacturing environment.
Proficient in Microsoft Word and Excel
Diverse ability to understand manufacturing processes and communicate that throughout the organization
Must be able to calculate, and read millimeter rulers, calipers, and scales
Ability to stand for long periods
Able to move and lift-up to 50 lbs
Able to reach and bend
Availability to perform domestic and international travel as required – potentially not to exceed15%

Nice To Haves

Bachelor’s degree preferred

Responsibilities

Coordinate the initiation, documentation, and closure of CAPA records.
Ensure CAPAs are completed within defined timelines and meet quality and regulatory standards.
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.
Collaborate with cross-functional teams to develop effective corrective and preventive action plans.
Monitor and verify the implementation and effectiveness of CAPAs.
Ensure that actions taken adequately address the root cause and prevent recurrence throughout all Shrink Sleeve operations (BTN; NC; FSPM)
Maintain accurate and complete CAPA records in the quality management system (QMS) through Integrify
Generate regular reports and metrics on CAPA status, trends, and performance for management review on a weekly and monthly basis.
Support internal and external audits by providing CAPA documentation and status updates.
Train departments on root cause and corrective action methodologies( 5 WHY or 8 D) as needed.
Identify opportunities to improve CAPA processes and overall quality system performance across all operational sites ( BTN; NC and FSPM)
Report on completion of cross operational CAPA review weekly and monthly to Site QA Leader and or Quality Director.
Perform additional responsibilities as assigned to support the success of the quality department and the organization.
Be the back up for QA CAR Coordinator and P&G Engineer as needed