Specialist I, Quality Assurance, IOVA-A QA Ops - Tuesday to Friday from 7am-5pm [Contract to Hire]
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About The Position
Iovance Biotherapeutics is a global leader in innovation, development, and delivery of tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. Our recent launch of AMTAGVI and associated growth has led to the creation of a new position. The Specialist I - IOVA-A QA Ops will be a key role that ensures adequate Quality oversight for the manufacture and disposition of irradiated peripheral blood mononuclear cells (iPBMCs) manufactured in-house. The Specialist I will be a strong and action-oriented team member who is capable of driving projects to completion. The role will report to the Supervisor/Manager - IOVA-A QA Ops. The Specialist I is responsible for day-to-day Quality Assurance Operations activities in accordance with cGMPs, CFRs, ICH guidelines and company policies and procedures. The Specialist I will work onsite alongside manufacturing and quality control personnel, helping to ensure that the highest standard of work is performed for Iovance's in-house iPBMC manufacturing activities at 700 Spring Garden St, Philadelphia, PA., which is co-located at the American Red Cross Penn Jersey Region. This individual is collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability. The Specialist I will support Quality Assurance lot release and disposition activities including process observation, batch record review, and completion of lot release documentation. The Specialist I supports Quality Assurance initiatives including, but not limited to, review of laboratory investigations and deviation investigations. The successful candidate will support internal teams and be able to effectively communicate bi-directionally in a complex, changing, and fast-paced environment.
