Quality Assurance Lead Coordinator

Posted 19 Days Ago
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Port Neches, TX
Senior level
Manufacturing
The Role
The Quality Assurance Lead Coordinator oversees the Quality Management System, ensuring compliance with regulations, leading audits, managing certifications, and promoting continuous improvement within the quality and safety framework.
Summary Generated by Built In

Job Description:

Indorama Ventures- Indovinya is looking for a Quality Assurance Lead Coordinator to join our Quality Lab team in Port Neches, Texas. 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 Indorama – Indovinya policies.

What will be expected from you? 

Quality Management and Compliance

  • 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.

Program Development

  • 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 EXCiPACT

  • 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.

Audit Responsibilities

  • 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.

Regulatory Developments

  • 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.

Supplier Management

  • 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).

Continuous Improvement

  • 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.

Additional Responsibilities

  • 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.

What are we looking for in the ideal candidate? 

  • 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.
  • Experience working with regulatory agencies and external consultants (preferred)
  • Lead ISO9001 Auditor.
  • Lead Auditor for GMP/GDP/ GFSI Certification (BRC, FSSC 22000, EXCiPACT, RC14001, RSPO, etc.)
  • Green Belt certification (minimum)
  • Advanced Knowledge of ISO standards (9001, 14001, 45001, 22000), RSPO, BRCGS, EFfCI, FSSC 22000, pharmaceutical norms and standards (EXCiPACT), GMPs, and prerequisites.
  • Preferred Knowledge of Microbiology, risk analysis (FMEA, HACCP), food, cosmetic, agrochemical, and surfactant industries.
  • 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.

What can we offer you?  

Indorama Ventures- Indovinya is a leading chemical intermediates and surfactants producer with a diverse range of products in growth markets such as home & personal care, agrochemicals, oilfield technologies, fuel & lube additives and more.  The successful candidate will receive a competitive compensation and will be eligible to participate in a comprehensive benefits package which includes: medical, vision and dental, basic life insurance, AD&D insurance, and 401k. Here, you can make an impact and make a difference. Come join us! 

Additional Locations:

Top Skills

Brcgs
Excipact
Fssc 22000
Gmps
Haccp
Iso 14001
Iso 22716
Iso 45001
Iso 9001
MS Office
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SAP
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The Company
HQ: The Woodlands, TX
610 Employees
On-site Workplace
Year Founded: 2010

What We Do

Indorama Ventures Oxides & Derivatives is a leading chemical intermediates and surfactants producer with a diverse range of products in growth markets such as home & personal care, agrochemicals, oilfield technologies, fuel & lube additives and more. In January 2020, Indorama Ventures Public Company Limited completed its acquisition of Huntsman’s world-class integrated oxides and derivative business, including:

Surfactants: Integrated producer of a wide range of products for home and personal care, oilfield technologies, agriculture and process industries.

Ethylene & Derivatives: Highly integrated manufacturer of ethylene, ethylene oxide, ethylene glycol, ethanolamines and other derivatives.

Propylene Oxide & Derivatives: Highly competitive technology offerings in propylene glycol, methyl tertiary butyl ether (MTBE) and other derivatives.

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