The Specialist 2, Validation / Technical Assurance provides critical testing, sampling, incoming material inspection, and technical support for the Quality Assurance department within the warehouse/logistics area. This individual serves as a Subject Matter Expert (SME) for sampling and inspection operations covering chemical components, raw materials, bulk products, containers/closures, labeling, and primary/secondary packaging materials, ensuring strict adherence to cGMP, FDA regulations, company SOPs, and safety standards.
- Education: High School Diploma or GED required (Associate or Bachelor's degree in Chemistry, Biology, Life Sciences, or related field is a plus).
- Experience: Minimum 4+ years of hands-on experience in a Pharmaceutical, Biopharmaceutical, or OTC manufacturing facility.
- Logistics & Warehousing Systems: Demonstrated experience with warehouse management systems (WMS), inventory control, and raw material intake workflows.
- Quality & cGMP Rigor: Strong knowledge of cGMP guidelines, 21 CFR Part 210/211, and Good Documentation Practices (GDP).
- Communication & Collaboration: Proven ability to communicate effectively across warehouse operators, quality control, lab analysts, and regulatory teams.
- Technical Systems & Tools
- ERP: SAP (WM/MM/QM modules preferred) or similar enterprise ERP.
- LIMS: Laboratory Information Management Systems (SampleManager, LabWare, etc.).
- Quality & Manufacturing Systems: Electronic Batch Records (eBR), TrackWise, Veeva Vault, or MasterControl.
- Office Applications: Microsoft Excel, Word, and Outlook.
Preferred Qualifications :
- Prior experience with AQL (Acceptable Quality Limit) sampling tables (e.g., ANSI/ASQ Z1.4).
- Background supporting Quality Control (QC), incoming inspection, or Quality Assurance (QA) release.
- Exposure to Lean, Six Sigma, 5S, or continuous improvement initiatives..
- Incoming Sampling & Inspection: Perform compliant sampling, physical testing, and incoming inspection of raw chemical components, bulk drug products, container closures, labels, and packaging components.
- Packaging Disposition & Material Review: Support packaging material reviews, line clearance, component release, and disposition workflows within the warehouse and production areas.
- Laboratory Sample Coordination: Accurately prepare, label, package, document, and transfer samples to the Analytical/QC testing laboratories under strict chain-of-custody protocols.
- SOPs & Continuous Improvement: Draft, review, and update Standard Operating Procedures (SOPs); assist with process improvements, Lean manufacturing, and Operational Excellence (OpEx) projects.
- Audit & Inspection Readiness: Actively support internal quality audits and external regulatory inspections (e.g., FDA); assist in documenting, investigating, and resolving audit observations.
- Investigations & Deviations: Participate in quality investigations, non-conformances (NCR), Out of Specification (OOS) findings, and root-cause analysis (RCA) within automated quality systems.
- Training & Mentorship: Serve as an SME to train, mentor, and qualify incoming sampling technicians and inspection personnel on cGMP techniques and sampling tools.
- Component Tracking & Metrics: Track annual testing cycles, re-inspection schedules, vendor qualification samples, and component shelf-life status in ERP/inventory systems.
- Compliance & Record Keeping: Maintain accurate, contemporaneous Good Documentation Practices (GDP) across Electronic Batch Records (eBR), LIMS, and SAP.