QA Lead Coordinator

Together We Make Life Better". Our quality engineering, sustainable solutions and safety record inspire everything we do. Our diverse and inclusive workforce allows for all employees to feel valued and safe to give their opinions and improve our company.

Tata Consulting Engineers USA, LLC, (TCE), is a multi-disciplinary engineering organization offering a full range of integrated engineering design, project support, procurement and construction management services to the energy and chemicals industries.

Note: This is a 6 Month+ assignment

The Quality Assurance Lead Site Coordinator (QAC) independently manages and directs the Integrated and Quality Management Systems (EHSQ IMS) for both the Pasadena and Dayton sites. The QAC establishes, implements, and maintains the QMS through internal and external audits; monitors quality metrics and reports status to site and corporate management; drives preventive actions to meet regulatory standards (HACCP, GMPs, ISO 9001, FSSC 22000, EFfCI, EXCiPACT, RC14001, RSPO, FDA, Kosher, Halal, etc.); and monitors non-conformances from internal, external, and third-party sources to ensure products and processes align with client policies

ROLE

• Management of Quality and Food Safety MS
• Product Safety Committee Lead
• Lead Internal and External Audits
• Subject Matter Expert (QMS / FSMS / Validation / EXCiPACT, where applicable)

AUTHORITY

• Coordinate and lead site Quality Committees.
• Coordinate the Quality, Food and Product Safety Committees.
• Make changes to validation plans and programs, where applicable.
• Manage the updating and generation of procedures and protocols for validation of equipment, systems, and/or processes.
• Manage the local Quality Management System.
• Authority to stop any product, process, service, or activity that puts at risk the quality, legality, or safety of products, or jeopardizes the physical integrity of people, the environment, and/or facilities/infrastructure.
• Determine the appropriateness, applicability, and effectiveness of actions to close non-conformities.

RESPONSIBILITY

With minimal supervision, exercising independent judgement and decision-making across both sites:

1. Quality & Safety Management System - Compliance

• Continuously ensure compliance of the Quality and Food Safety Management. System with applicable standards and regulations as applicable.
• Develop and maintain quality assurance objectives in support of company policies and goals.
• Define KPIs and their criteria with a continuous improvement approach and governance.
• Cascade corporate quality targets across both sites and provide guidance on site-level KPIs.
• Update and control the Document Management System, where applicable.
• Promote, influence, and ensure compliance with the Quality and Food Safety Management System.
• Implement Good Manufacturing Practices (GMPs).
• Review and assure implementation of site policies, guidelines, procedures, RACI matrix, and standards aligned with segment and global governing documentation.
• Evaluate certification requirements for products, raw materials, and processes.
• Answer customer requests related to the Quality and Food Safety System.
• Prepare area performance reports.

1. Certifications & Standards Management

• Maintain certifications at both sites: ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 22716, RSPO, EXCiPACT, FSSC 22000, EFfCI, RC14001/RCMS, Kosher, Halal, etc.
• Maintain certifications via risk analysis, potential and real nonconformities, seeking continuous improvement.
• Lead the development and implementation of new quality-related certifications. aligned with changing business strategy.
• Coordinate Kosher and Halal activities for both sites, including obtaining. documented approval for raw materials and finished products.

1. Audit Program Management

• Develop and manage the annual internal and external audit schedules.
• Coordinate 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.
• Coordinate, host, and participate in quality audits (internal and external) and Customer visits, responding with appropriate corrective action.
• Lead the internal quality auditing program; work with the site audit teams to ensure audits are completed according to schedule.
• Oversee audit execution and compliance.
• Review and approve audit reports.
• Document and follow up audit findings through to closure.
• Ensure responses and actions are completed on all audit findings and properly logged into the tracking system.
• 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 prepare audit result reports.

1. Risk, Validation & HACCP

• Develop validation master plans for both sites.
• Develop cleaning and CCP (Critical Control Points) validations.
• Develop validation protocols.
• Continuously ensure compliance with validation programs and plans, and evaluate revalidation needs.
• Execute validations in accordance with the validation master plan and applicable protocols.
• Investigate system NCRs and root cause failure analysis.
• Develop and monitor HACCP at both sites; report issues to Management.
• Implement and train risk analysis: FMEA & HACCP.
• Support the company in the quality risk mindset and tools (HACCP, FMEA).

1. Non-Conformance, Customer Complaint & CAPA Management

• Oversee internal and external quality nonconformities at both sites: communication, investigation, treatment, response time to customers, and lessons learned.
• Facilitate the investigation of Customer Complaints against the facilities and ensure effective corrective actions.
• Investigate and respond to customer complaints and non-conformances.
• Manage follow-up of non-conformities and contribute to the preparation of root cause analyses.
• Assist with follow-up and verification of Corrective and Preventive Actions (CAPAs).
• Perform periodic analysis and trending of nonconformances identified from internal/external audits, customer complaints, and quality nonconformities; communicate results and facilitate development of CAPA plans.
• Prepare and distribute reports/investigations on customer complaints, investigations, etc.
• Oversee the Waivers process.

1. Regulatory & Legal Compliance

• Monitor the Foreign Supplier Verification Program (FDA - FSVP).
• Assess legal requirements applicable to both sites and other relevant facilities.
• Maintain regulatory compliance with FDA, RC14001/RCMS, Cosmetic and Pharmaceutical GMP/GDP/GWP.

1. Supplier Management

• Qualify and monitor suppliers; support and carry out 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).

1. 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 tools: FMEA & HACCP.
• Promote continuous improvement for quality processes based on external benchmarking.
• Develop special projects assigned by top management - process mapping, SOPs, 5S programs.
• Apply Lean Six Sigma methodology where applicable.

1. Training & Onboarding

• Develop and deliver Quality Assurance training.
• Conduct quality onboarding for new employees at both sites.
• Perform and support site training related to QA.
• Participate in and complete company-required training programs.

1. Program Development, Reporting & Management Reviews

• Lead local Quality & Product Safety Committees at both sites.
• Set up, prepare, and lead Management Reviews for Pasadena and Dayton.
• Coordinate recall, non-conformance, and food safety teams.
• Monitor quality metrics and report status to senior management.
• Provide feedback and approval during the New Product Introduction (NPI) process.

1. Budget, General Support & EHS Participation

• Manage budget and process invoices for the QA program at both sites.
• Provide Quality and Technical assistance to plant personnel, customers, and segment.
• Support other functions in QA-related aspects or inquiries.
• Work collaboratively with team members and other departments and business functions.
• Participate in Environmental, Health, and Safety initiatives as set forth by the company.
• Perform and support activities at other facilities/locations as requested by the direct supervisor.

Follow instructions and perform other duties as may be assigned by supervisor.

This is at the Pasadena location with possible weekly day trips to the Dayton location

Chem Manufacturing exp.

Advanced knowledge in GMP requirements and ISO.

Ability to Lead/manage Quality Assurance Programs complaint with GMP/GFSI/ISO.

Internal/External Audits working knowledge.

Bachelor's degree in chemistry or other closely related fields

Tata Consulting Engineers USA, LLC ("TCE") is an equal opportunity and affirmative action employer committed to promoting diversity, equity, and inclusion in our workplace. We do not discriminate on the basis of race/ethnicity, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, veteran's status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

In compliance with federal law, all candidates hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form after acceptance of a formal TCE offer letter through our onboarding system.

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