Quality Systems & Raw Material Risk Specialist

Job Title:
Quality Systems & Raw Material Risk Specialist

Duration: 6 months (possibility of extension)

Location:
Erlanger KY
Pay rate: $26.00 - $28.00 hourly on W2

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.

• 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.

• 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.

• 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 alternate source material reviews and change management activities.
• Assist with investigation and resolution of raw material-related issues.

• Maintain controlled documents within the electronic Quality Management System (eQMS) & within the shared drive including procedures, work instructions, specification sheets, forms, and records.
• Maintain quality specifications by supporting the review, revision, approval, and document control process for raw materials and finished products. Ensure updated specifications are properly maintained, communicated, and archived in accordance with established procedures. Monitor document expiration dates and coordinate periodic reviews with document owners.
• Support implementation and continuous improvement of document control processes.
• Maintain accurate quality records to support internal, customer, and regulatory audits.

• Support the Quality and Food Safety team with implementation and maintenance of the Food Safety Management System.
• Assist…