We are seeking a detail-oriented Raw Material Quality Specialist to join a leading manufacturer of topical animal health and wellness products. This role is responsible for overseeing the full lifecycle of incoming raw materials—from initial receipt and inspection to testing and final release. You will play a critical role in ensuring that all materials used in production meet USP, FDA, and internal quality standards, collaborating closely with procurement and manufacturing teams to maintain a compliant and efficient supply chain.
Inspection & Sampling: Perform visual inspections of incoming materials for damage or contamination; collect representative samples for testing following SOPs and regulatory guidelines.
Testing & Release: Execute identity tests, interpret results against USP or internal specifications, and manage the quarantine/release process to ensure production timelines are met.
Documentation: Maintain precise records for all receipts, COAs, and test results. Investigate non-conforming materials and support regulatory audits.
Vendor Qualification: Evaluate new vendors and materials based on quality history and risk; assist in the creation and approval of raw material specifications.
Compliance: Ensure strict adherence to GMP, GLP, and safety procedures during all material handling activities.
Education: Bachelor’s Degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific field.
Experience: 5+ years of experience in raw material receiving and qualification within a regulated environment (Pharmaceutical, Biotech, or Cosmetics).
Technical Knowledge: Strong working knowledge of USP/NF standards, FDA regulations, and GMP/GLP requirements.
Systems: Proficiency in ERP/Inventory systems (e.g., SAP, Oracle) and Microsoft Office Suite (Excel, Word, Outlook).
Skills: Ability to read and interpret technical documents (SOPs, Batch records) and make sound quality judgments independently.
Shift Flexibility: Ability to work on-site with flexibility for evenings, weekends, or overtime as production demands require.
Physical Activity: Continual standing/walking; ability to bend, stoop, reach overhead, and occasionally lift up to 50 lbs.
Environment: Must be comfortable working in temperature-controlled environments (cold rooms or warm production areas) and wearing full PPE (masks, gowns, gloves, etc.).
Sensory: Specific vision abilities (color, depth, and focus) are required for material inspection and testing.
Regulatory Compliance: cGMP, GLP, FDA Regulations, USP/NF Standards, OSHA Safety Standards.
Quality Control: Raw Material Inspection, Sampling Protocols, Identity Testing, COA (Certificate of Analysis) Review, Quarantine Management, Specification Development.
Quality Assurance: Document Control, SOP (Standard Operating Procedure) Writing, Change Control, Vendor Qualification, Audit Preparation, Non-Conformance Investigation (NCMR).
Laboratory & Technical: Analytical Testing, Batch Record Review, Technical Documentation, Material Traceability, Safety Data Sheets (SDS).
Software: ERP Systems (SAP, Oracle, or Microsoft Dynamics), Inventory Management Software, Advanced Excel (VLOOKUP/Pivot Tables), Microsoft Office Suite.