Quality Systems & Raw Material Risk Specialist - Erlanger, KY

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Quality Systems & Raw Material Risk Specialist
- Erlanger, KYQuality Systems & Raw Material Risk Specialist
- Erlanger, KY

KY
- Kentucky

Operations:
Manufacturing, Production, Maintenance, Utilities

Job Description

Quality Systems & Raw Material Risk Specialist
- Erlanger, KY
Quality System Sustainability
The position will provide the necessary support to sustain current and future quality system requirements, including eQMS implementation, controlled documentation, corrective actions, and continuous improvement activities.
Expected Outcomes

• Improved timeliness of raw material approvals and supplier documentation reviews.
• Reduced backlog of quality workflows and document control activities.
• Increased visibility of raw material risks and approval status.
• Improved audit preparedness and compliance confidence.
• Increased capacity for Quality & Food Safety leadership to focus on risk reduction, improvement projects, and site initiatives.

Job Description

Quality Systems & Raw Material Risk Specialist - Erlanger, KY
Quality System Sustainability
The position will provide the necessary support to sustain current and future quality system requirements, including eQMS implementation, controlled documentation, corrective actions, and continuous improvement activities.
Expected Outcomes

• Improved timeliness of raw material approvals and supplier documentation reviews.
• Reduced backlog of quality workflows and document control activities.
• Increased visibility of raw material risks and approval status.
• Improved audit preparedness and compliance confidence.
• Increased capacity for Quality & Food Safety leadership to focus on risk reduction, improvement projects, and site initiatives.

Proposed Job Summary
Quality Systems & Raw Material Risk Specialist supports the Quality and Food Safety Management System by managing raw material approval activities, supplier documentation, risk assessments, and controlled documents. This role ensures raw materials meet regulatory, customer, food safety, and quality requirements prior to introduction and continued use.
This position serves as a key link between Quality, Regulatory, Procurement, Operations, Research & Development, and suppliers to ensure timely completion of raw material reviews and accurate maintenance of quality records. The specialist will support compliance with applicable standards including ISO 22000, customer requirements, GMP expectations, and internal Quality Management System requirements.

Key Responsibilities
Raw Material Risk Management

• Manage the raw material approval process including collection, review, and tracking of required documentation.
• Perform raw material risk assessments to evaluate food safety, quality, regulatory, allergen, foreign material, and supplier-related risks.
• Review supplier documentation including specifications, Safety Data Sheets (SDS), certificates, statements, questionnaires, and supporting quality documents.
• Partner with Regulatory, Quality, Procurement, and suppliers to resolve documentation gaps and ensure materials meet requirements prior to use.
• Maintain food safety documentation for established suppliers by requesting updated supplier records, certifications, and supporting documentation. Ensure document control through review, replacement of expired documents, and archival of obsolete records. Support ongoing supplier documentation maintenance for approved suppliers separate from new raw material and alternate source qualification activities.
• Maintain visibility of raw material approval status and communicate risks, delays, and required actions.
• Support tracking of quality metrics, workflows, and overdue actions.
• Maintain accurate quality records to support internal, customer, and regulatory audits.

Quality & Food Safety Support

• Support the Quality and Food Safety team with implementation and maintenance of the Food Safety Management System.
• Assist with audit preparation, corrective actions, and continuous improvement initiatives
• Sup…