QA Lead Coordinator

CDI Engineering Services-posted 3 months ago
Port Neches, TX
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The Quality Assurance (QA) Lead Coordinator ensures the establishment, implementation, and maintenance of the Quality Management System (QMS) through audits, aiming for compliance and continuous improvement of the Quality and Food Safety System. This role promotes preventive actions to meet regulatory standards (HACCP, GMPs, ISO 9001, EFFCI, among others) and monitors non-conformances arising from various sources, ensuring products and processes are in line with the client.

  • Support Quality and Safety Management System Manager, Product Safety and Committee Leader.
  • Leader of the Product Safety Committees of all units for validation issues.
  • Complete Internal Auditor.
  • Manage the execution of the Validation Master Plan.
  • Manage the updating and generating of procedures and protocols for the validation of equipment, systems and/or processes.
  • Quality Management and Compliance.
  • Define KPI's and criteria with continuous improvement and approach.
  • Update and assist in managing Document Management Systems.
  • Promote and ensure compliance.
  • 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.
  • Coordinate recall, non-conformance and food safety teams.
  • 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.
  • 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.
  • 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.
  • 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.
  • Maintain current quality certifications, executing actions based on risk analysis, potential and real nonconformities, seeking continuous improvement.
  • Implement new quality certifications aligned with business strategy.
  • Monitor the Foreign Supplier Verification Program-FDA.
  • Assess legal requirements applicable to various sites.
  • Qualify and monitor suppliers, supporting supplier audits.
  • Carry out and follow up on the supplier audits and internal audits program.
  • Selection and monitoring of suppliers.
  • Manage customer paperwork required for quality critical analysis (questionnaires, quality agreements, contracts, statements).
  • Define KPIs and their criteria with a continuous improvement approach and governance.
  • Promote, influence, and ensure compliance with the Quality and Safety Management System.
  • Implement and train risk analysis: FMEA & HACCP.
  • Promote continuous improvement for quality processes based on external benchmarking.
  • Experience Establishing, implementation and maintenance of the Quality Management System (QMS).
  • Auditing Experience.
  • Experience Ensuring 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.).
  • Previous in plant experience required.
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