Indorama Ventures: Indovinya · 1 day ago
Quality Assurance Lead
Port Neches, TX
Full-time
Onsite
Senior Level
7+ years expIndorama Ventures- Indovinya is looking for a Quality Assurance Lead Coordinator to join their Quality Lab team in Port Neches, Texas. This role is responsible for ensuring the establishment, implementation, and maintenance of the Quality Management System while promoting compliance and continuous improvement of quality and food safety standards.
Chemicals
Hiring Manager
Mary Colbert, MBA
Responsibilities
Quality and Safety Management System Manager
Product Safety Committee Leader
Leader of the Product Safety Committees of all units for validation issues
Internal Auditor
Manage the execution of the Validation Master Plan
Make changes to Validation plans and programs
Manage the updating and generation of procedures and protocols for the validation of equipment, systems, and/or processes
Manage local Quality Management system
Product Safety Management
Authority to stop any product or service that puts at risk the quality, legality, or safety of the products, as well as any activity that puts at risk the physical integrity of people, the environment, and/or facilities
Determine the appropriateness and effectiveness of actions to close non-conformities
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, 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
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
Qualification
Required
Bachelor's degree in Chemistry, Biology, Chemical or Industrial Engineering, or a closely related field
Experience in Chemical / Petrochemical industry
Language: English fluent
7 years of experience in Quality Assurance
Lead ISO9001 Auditor
Lead Auditor of GMP/GDP/ GFSI Certification (BRC, FSSC 22000, EXCiPACT, RC14001, RSPO, etc.)
Advanced Knowledge: ISO standards (9001, 14001, 45001, 22000), RSPO, BRCGS, EFfCI, FSSC 22000, pharmaceutical norms and standards (EXCiPACT), GMPs, and prerequisites
Strong organizational and project management skills, capable of managing multiple audits simultaneously
Excellent analytical and problem-solving skills
Proficiency in audit management software and data tracking tools
Thoroughness and accuracy in audit planning, execution, and reporting
Strong relationship-building with internal and external stakeholders to achieve audit objectives
Alignment of audit activities with organizational goals and regulatory requirements
Clear articulation of audit findings, expectations, and recommendations to diverse audiences
Strong commitment to ethical practices in all audit activities
Proficiency with SAP, and Microsoft Office programs (including SharePoint and PowerBI)
Strong facilitation and team-building skills
Excellent oral and written communication skills, effective at all organizational levels
Ability to work independently and as part of a team
Ability to learn new techniques, multitask, keep accurate records, follow instructions, and comply with company policies
Detail-oriented with a strong sense of safety awareness
Strong organizational and time management skills
Ability to change priorities while meeting deadlines
Facilitator of change
Preferred
Experience working with regulatory agencies and external consultants
Green Belt certification
Preferred Knowledge: Microbiology, risk analysis (FMEA, HACCP), food, cosmetic, agrochemical, and surfactant industries
Company
Indorama Ventures: Indovinya
Indovinya is the global specialty chemical and surfactants division of Indorama Ventures, with operations across 10 countries and 15 manufacturing locations.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase