Raw Material Quality Specialist
On-siteJupiter, Florida, United States
Jupiter, Florida, United StatesOn-siteFull TimeBachelors DegreeSmall
Full TimeBachelors DegreeSmall
Job Summary
Oversee the full lifecycle of incoming raw materials, performing visual inspections for damage or contamination and collecting representative samples per SOPs. Execute identity tests, interpret results against USP or internal specifications, and manage the quarantine/release process to ensure production timelines. Maintain precise records for receipts, COAs, and test results while investigating non-conforming materials and supporting regulatory audits. Evaluate new vendors based on quality history and risk, and ensure strict adherence to GMP, GLP, and safety procedures during all material handling activities.
Required Qualifications
- Bachelor's Degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific field
- 5+ years of experience in raw material receiving and qualification within a regulated environment (Pharmaceutical, Biotech, or Cosmetics)
- Strong working knowledge of USP/NF standards, FDA regulations, and GMP/GLP requirements
- Proficiency in ERP/Inventory systems (e.g., SAP, Oracle) and Microsoft Office Suite (Excel, Word, Outlook)
- Ability to read and interpret technical documents (SOPs, Batch records) and make sound quality judgments independently
- Ability to work on-site with flexibility for evenings, weekends, or overtime as production demands require
- Continual standing/walking; ability to bend, stoop, reach overhead, and occasionally lift up to 50 lbs
- Specific vision abilities (color, depth, and focus)
- cGMP, GLP, FDA Regulations, USP/NF Standards, OSHA Safety Standards
- Raw Material Inspection, Sampling Protocols, Identity Testing, COA (Certificate of Analysis) Review, Quarantine Management, Specification Development
- Document Control, SOP (Standard Operating Procedure) Writing, Change Control, Vendor Qualification, Audit Preparation, Non-Conformance Investigation (NCMR)
- Analytical Testing, Batch Record Review, Technical Documentation, Material Traceability, Safety Data Sheets (SDS)
- ERP Systems (SAP, Oracle, or Microsoft Dynamics), Inventory Management Software, Advanced Excel (VLOOKUP/Pivot Tables), Microsoft Office Suite
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