QA Lead Coordinator

CDI Engineering Services•Port Neches, TX

About The Position

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 client policies.

Requirements

Quality and Safety Management System Manager.
Product Safety Committee Leader.
Leader of the Product Safety Committees of all units for validation issues.
Internal Auditor Chem Manufacturing exp.
Chem Manufacturing exp.
Advanced knowledge in GMP requirements and ISO.
Ability to Lead/management.
Internal/External Audits.
BRCGS certification can be reviewed.
Experience Managing local Quality Management system.
Experienced Managing the updating and generation of procedures and protocols for the validation of equipment, systems, and/or processes.
Experience auditing.
Experience with Program Development.
Risk, Validation & Compliance.

Responsibilities

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.
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.
Develop and monitor the annual internal and external audit program, including implementation.
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.
Develop initiatives and programs to promote quality standards.
Implement and train risk analysis: FMEA & HACCP.
Promote continuous improvement for quality processes based on external benchmarking.
Update and control the Document Management System.
Conduct quality onboarding for new employees.
Investigate and respond to customer complaints and non-conformances.
Provide feedback and approval during the new product introduction process.
Manage budget and process invoices.
Support other functions in QA-related aspects or inquiries.
Perform and support other activities at other facilities/locations as requested by the direct supervisor.