Raw Material Sampling Coordinator

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Raw Material Sampling Coordinator is responsible for the controlled sampling of incoming GMP raw materials and components following receipt and quarantine, and for the timely transfer of representative samples to Quality Control (QC) for testing and disposition. This role performs sampling activities in approved sampling areas using qualified equipment, approved procedures, and appropriate personal protective equipment to protect sample integrity, prevent contamination and cross-contamination, and maintain complete traceability. The Raw Material Sampling Coordinator serves as the operational link between Materials Management and Quality Control for incoming material sampling. The position reviews sampling requirements, coordinates priorities, performs and documents sampling, maintains chain of custody, completes applicable ERP and/or LIMS transactions, and returns sampled materials to the appropriate controlled storage status. The role also supports deviation investigations, audit readiness, housekeeping, and continuous improvement while maintaining compliance with cGMP, Abzena procedures, and data integrity expectations. Responsibilities Support and ensure compliance with 21 CFR, cGMP regulations, Abzena's Quality Management System (QMS), Standard Operating Procedures (SOPs), approved material specifications, sampling plans, and all applicable company policies. Review incoming material receipt documentation, material status, lot information, container counts, and applicable sampling requirements before initiating sampling activities. Coordinate daily raw material sampling priorities with Materials Management, Quality Control, Supply Chain, and Manufacturing to support material release and manufacturing readiness. Inspect incoming material containers for identity, labeling, seal integrity, damage, cleanliness, and other visible conditions that could affect material quality or sampling suitability, and escalate discrepancies before sampling. Stage and move quarantined raw materials into approved sampling locations while maintaining material status segregation, traceability, required environmental conditions, and appropriate handling controls. Perform representative raw material sampling using approved procedures, sampling tools, qualified equipment, and required PPE while minimizing contamination, cross-contamination, and exposure risk. Perform aseptic or controlled sampling activities in a biological safety cabinet, sampling booth, or other qualified area when required by the material, specification, or procedure. Accurately label sample containers and document sample identity, material code, supplier lot, internal lot, quantity, sampling date, sampler identification, and other required traceability information. Maintain sample chain of custody from collection through handoff to QC or an approved external testing laboratory, including timely delivery under required storage or temperature conditions. Complete required ERP, inventory, LIMS, logbook, and controlled documentation transactions accurately and contemporaneously in accordance with data integrity and good documentation practice requirements. Ensure sampled source containers are properly resealed, relabeled as required, and returned to the correct quarantine or…

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