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.
Primary Responsibilities
- 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.
Qualifications
- 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.
Physical Requirements & Work Environment
- 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.
Requirements
Technical & Industry Skills
- 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.