Associate Technical Writer (Deviation Assessment), CAR-T Manufacturing Technical Support

Role: Associate Technical Writer specializing in Deviation Assessment within CAR-T manufacturing technical support. Objectives include collaborating with Manufacturing, QA, MSAT, and EHS to support GMP document updates, deviations, CAPAs, and Change Controls. Core responsibilities involve reviewing and authoring GMP documentation, conducting deviation investigations, managing CAPAs and Change Controls, ensuring timely completion, and facilitating continuous improvement efforts. Requirements: Bachelor’s degree (or equivalent experience) in a scientific or technical field, with 1-2 years of manufacturing, QA, or technical writing experience in a cGMP and FDA-regulated environment. Knowledge of GMP manufacturing, quality systems, and technical writing skills are essential. Preferred skills include experience with CAR-T cell therapy and familiarity with GMP documentation processes. High-value specifics include focus on cell therapy (CAR-T), GMP compliance, deviation and CAPA management, and cross-functional collaboration across manufacturing and quality teams. Work setup is primarily on-site, with possible clean room interactions, and some flexibility based on business needs.