Quality Assurance Lead Coordinator

Quality Assurance Lead Coordinator

Location: Port Neches, TX 77651

Job Description:

• Strong knowledge of GMPstandards (EXCiPACT, FSSC22000, BRCGS, etc.). Not just participationor attendancebut a subject matter expert level of knowledge and ability to lead the GMP (goodmanufacturing practices) program.
• Hands-on experience in facilitating and leading audits
• Experience in chemical manufacturing processes
• Define KPIs and their criteria with a continuous improvement approach and governance.
• Update and control the Document Management System.
• Promote, influence, and ensure compliance with the Quality and Safety Management System.
• Maintain current quality certifications, executing actions based on risk analysis, potential and real nonconformities, and seeking continuous improvement.
• Implement new quality certifications aligned with business strategy.
• Ensure that the quality and safety requirements of the products and production processes are met, adhering to standards and policies (ISO 9001, ISO 22716, ISO 14001, ISO 45001, RSPO, BRCGS, EXCiPACT, FSSC2200, EFfCI, Kosher, Halal, etc.).
• Implement GMP practices applicable to Quality Assurance
• Develop initiatives and programs to promote quality standards
• Develop and deliver training
• Manage budget and process invoices
• Support other functions in QA-related aspects or inquiries.
• Lead local Quality & Product Safety Committees
• Set up and lead management reviews
• Coordinate recall, non-conformance, and food safety teams
• Develop special projects assigned by top management such as mapping processes, SOPs, or implementing 5S programs.
  
  FSSC and EXCiPAC
• Maintain the QMS/ FSMS to keep all quality and food certifications: FSSC 22000, ISO 9001:2015, EFfCI, Kosher, Halal, and RSPO
• Develop and monitor the annual internal and external audit program, including implementation
• Pharma/ EXCiPACT expert - lead pharma certification projects.
  
  Risk, Validation & Compliance
• Develop validation master plans.
• Develop cleaning and CCP (Critical Control Points) validations.
• Develop validation protocols.
• Continuously ensure compliance with validation programs and plans, as well as the evaluation of revalidation needs.
• Execute validations in accordance with the validation master plan and applicable protocols.
• Investigate system NCRs and root cause failure analysis.
• Develop and manage audit schedules.
• Coordinate internal and external audit scopes, objectives, and timelines.
• Assign internal and external auditors, ensuring appropriate expertise and availability.
• Maintain a qualified audit team and engage external consultants as needed.
• Oversee audit execution and compliance.
• Review and approve audit reports.
• Document and follow up through to closure on audit findings.
• Collaborate on action plans for audit findings, and Monitor trends and share insights from audit findings with leadership.
• Implement best practices in audit processes.
• Conduct internal audits and manage audit processes.
• Prepare audit result reports.
• Tracking and Follow-Up
• Manage the follow-up of non-conformities and contribute to the preparation of root cause analyses.
• Ensure all audit findings are documented and followed through to closure.
• Monitor the quality metrics and report status to senior management.
• Develop and monitor the annual internal and external audit program, including implementation.
  
  

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