Quality Assurance IOVA-A Intern

Overview 

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 2024 FDA approval of AMTAGVI® is the first and only FDA-approved one-time T cell therapy treatment for individuals with previously treated melanoma that has spread or cannot be removed by surgery.  The Quality Assurance (QA) department ensures that day-to-day QA Operations activities are performed in accordance with current Good Manufacturing Practice (cGMPs), the Code of Federal Regulations (CFR), International Council for Harmonisation (ICH) guidelines and company policies and procedures. We work onsite alongside manufacturing and quality control personnel, helping to maintain the highest standard of work for Iovance’s in-house manufacturing activities at 700 Spring Garden St, Philadelphia, PA., which is co-located at the American Red Cross Penn Jersey Region.   The quality assurance intern will possess a passion for learning. Successful applicants will have an interest in Good Manufacturing Practices (GMP) manufacture of cellular materials. Candidate should have excellent communication skills and a proven history of innovation and teamwork. They should have the capacity to recognize problems and propose solutions.   At the completion of the program, the candidate will have an understanding of good documentation practices (GDP), good manufacturing practices (GMP) and quality assurance (QA) within a biotechnology manufacturing site. 

Responsibilities

• Shadow QA team members in their work


• Effectively interface with quality assurance and manufacturing departments to learn about the documentation review process 


• Work with SME mentor to develop overview of documentation review process


• Draft training script for documentation review process using existing template


• Integrate input from subject matter expert and trainers to create robust training script


• Reference current job aids in creation of training materials 


• Deliver a department presentation at the end of the program 

Education

• Candidate must currently be enrolled in an undergraduate degree program at an accredited university

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