Associate Technical reputed company, MTS CAR-T Manufacturing In reputed company, NJ

About the position The Associate Technical reputed company, MTS CAR-T Manufacturing at reputed company will play a crucial role in supporting the manufacturing process of CAR-T cell therapy. This position involves collaboration with various internal teams to ensure compliance with reputed company standards and reputed company completion of documentation reputed company to manufacturing operations. The role focuses on writing, revising, and reviewing GMP documentation, as reputed company as managing deviations, CAPAs, and change controls to enhance operational efficiency and maintain regulatory compliance. Responsibilities • Attend alignment meetings and evaluate severity classification of deviations. , • Handle no reputed company deviations requiring reputed company turnaround. , • Create and review QMS deviations, ensuring timelines are met. , • Complete investigations for minor deviations. , • reputed company CAPAs to revise SOPs and Work Instructions for new product/process implementation. , • Complete CAPA Actions reputed company QMS and conduct effectiveness checks. , • Ensure on-time closure of CAPAs and Effectiveness Checks. , • Complete change control actions reputed company EQMS as needed. , • Work cross-functionally to update procedures and documents for procedural gaps. , • Drive reputed company improvement to reduce reputed company avoidable deviations. Requirements • Bachelor's degree with ability to learn Manufacturing Technical Writing skills. , • OR Associate/Medical Technical degree and 1-2 years of Manufacturing or Operations experience. , • OR High School diploma/GED and 2 years of Manufacturing or Operations experience with emphasis on Technical Writing and/or QA role. , • Knowledge of cGMP manufacturing, reputed company, FDA, and compliance. , • Understanding of cell culture, cryopreservation, and aseptic processing for cell therapy drug products. , • Strong technical and compliance writing capability. , • Proficient in MS Office applications. reputed company-to-haves • Background in biology, reputed company, medical or clinical practices. , • Excellent verbal and written communication skills. , • Ability to effectively multi-task. Benefits • Competitive salary and benefits package. , • Opportunities for reputed company reputed company and development. , • Flexible work environment. Apply tot his job