CPC & Associates
The QA Lead Coordinator is responsible for leading the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) and Food Safety Management System (FSMS) across a multi-unit chemical manufacturing facility.
This role ensures compliance with a broad range of international standards and certifications including EXCiPACT, FSSC22000, cGMP, GDP, Halal, Kosher, ISO9001, RSPO, and RC14001. The QA Lead will also serve as the Food Safety/Product Safety Committee Leader, driving quality culture, audit readiness, and regulatory compliance.
Responsibilities:
Lead the execution and governance of QMS and FSMS across all production units.
Maintain and expand certifications: ISO 9001, RC14001/
ISO 14001, RSPO, EXCiPACT, FSSC22000, EFfCI, Kosher, Halal
Promote and enforce GMP, GDP, and food safety standards.
Define and monitor KPIs with a continuous improvement mindset.
Lead internal and external audits, including scheduling, execution, reporting, and closure of findings.
Author and maintain SOPs, validation protocols (IQ/OQ/PQ), and technical documentation
Chair Food Safety Committees.
Implement and train on risk analysis tools such as FMEA and HACCP.
Coordinate recall, non-conformance, and food safety response teams.
Monitor and respond to regulatory developments, including FDA.
Qualify and monitor suppliers; conduct and follow up on supplier audits.
Develop and maintain Quality Agreements and ensure supplier compliance with QMS standards.
Manage customer quality documentation (questionnaires, agreements, statements).
Ensure supplier compliance with QMS and regulatory expectations.
Investigate non-conformances and lead root cause analysis and CAPA implementation.
Ensure adherence to FDA, ISO, FSMS, GMP, and other international regulatory standards
Conduct onboarding and ongoing training for QA staff and cross-functional teams on quality standards, regulatory requirements, and audit readiness
Facilitate Management Reviews and escalate quality issues to senior leadership.
Lead organizational change management initiatives and continuous improvement programs.
Collaborate with cross-functional teams including manufacturing, supply chain, R&D, and IT.
Provide QA support across departments including manufacturing, R&D, and supply chain.
Provide input in QA-related budgets and invoice processing.
Support other facilities and locations as needed.
Lead special projects such as implementation of 5S, process mapping, and system upgrades.
Qualifications:
Bachelors Degree in Chemistry, Biology, Chemical Engineering or a closely related field.
Minimum 710 years of experience in Quality Assurance, preferably in chemical manufacturing.
Experience with regulatory agencies is preferred.
ISO 9001 Lead Auditor (required).
Lead Auditor for GMP/GDP/GFSI Certifications (e.g., BRCGS, FSSC22000, EXCiPACT, RC14001, RSPO).
Advanced certifications preferred: ASQ Lead Auditor, Six Sigma (Green/Black Belt), ISO Auditor.
Advanced knowledge of ISO standards (9001, 14001, 45001, 22000, 22716), cGMP, GDP, HACCP, and food/cosmetic/agrochemical/surfactant industry standards.
Strong project management, analytical, and problem-solving skills.
Proficiency in SAP, SharePoint, PowerBI, Microsoft Office, and audit management tools.
Excellent communication and facilitation skills across all organizational levels.
Ability to manage multiple audits and projects simultaneously with attention to detail and safety.
This role ensures compliance with a broad range of international standards and certifications including EXCiPACT, FSSC22000, cGMP, GDP, Halal, Kosher, ISO9001, RSPO, and RC14001. The QA Lead will also serve as the Food Safety/Product Safety Committee Leader, driving quality culture, audit readiness, and regulatory compliance.
Responsibilities:
Lead the execution and governance of QMS and FSMS across all production units.
Maintain and expand certifications: ISO 9001, RC14001/
ISO 14001, RSPO, EXCiPACT, FSSC22000, EFfCI, Kosher, Halal
Promote and enforce GMP, GDP, and food safety standards.
Define and monitor KPIs with a continuous improvement mindset.
Lead internal and external audits, including scheduling, execution, reporting, and closure of findings.
Author and maintain SOPs, validation protocols (IQ/OQ/PQ), and technical documentation
Chair Food Safety Committees.
Implement and train on risk analysis tools such as FMEA and HACCP.
Coordinate recall, non-conformance, and food safety response teams.
Monitor and respond to regulatory developments, including FDA.
Qualify and monitor suppliers; conduct and follow up on supplier audits.
Develop and maintain Quality Agreements and ensure supplier compliance with QMS standards.
Manage customer quality documentation (questionnaires, agreements, statements).
Ensure supplier compliance with QMS and regulatory expectations.
Investigate non-conformances and lead root cause analysis and CAPA implementation.
Ensure adherence to FDA, ISO, FSMS, GMP, and other international regulatory standards
Conduct onboarding and ongoing training for QA staff and cross-functional teams on quality standards, regulatory requirements, and audit readiness
Facilitate Management Reviews and escalate quality issues to senior leadership.
Lead organizational change management initiatives and continuous improvement programs.
Collaborate with cross-functional teams including manufacturing, supply chain, R&D, and IT.
Provide QA support across departments including manufacturing, R&D, and supply chain.
Provide input in QA-related budgets and invoice processing.
Support other facilities and locations as needed.
Lead special projects such as implementation of 5S, process mapping, and system upgrades.
Qualifications:
Bachelors Degree in Chemistry, Biology, Chemical Engineering or a closely related field.
Minimum 710 years of experience in Quality Assurance, preferably in chemical manufacturing.
Experience with regulatory agencies is preferred.
ISO 9001 Lead Auditor (required).
Lead Auditor for GMP/GDP/GFSI Certifications (e.g., BRCGS, FSSC22000, EXCiPACT, RC14001, RSPO).
Advanced certifications preferred: ASQ Lead Auditor, Six Sigma (Green/Black Belt), ISO Auditor.
Advanced knowledge of ISO standards (9001, 14001, 45001, 22000, 22716), cGMP, GDP, HACCP, and food/cosmetic/agrochemical/surfactant industry standards.
Strong project management, analytical, and problem-solving skills.
Proficiency in SAP, SharePoint, PowerBI, Microsoft Office, and audit management tools.
Excellent communication and facilitation skills across all organizational levels.
Ability to manage multiple audits and projects simultaneously with attention to detail and safety.