Quality Control Compliance Specialist I

Responsibilities

• Perform Quality Control documentation and data management, including issuing testing forms, data filing, and storage
• Assist with Quality Control Documentation Projects by organizing files and executing standardized tasks
• Maintain lot lifecycle in LIMS by logging batches, entering data, and reviewing batches
• Create QC testing Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support product release
• Track the status of quality records within QC to ensure on-time completion
• Escalate roadblocks to record completion and provide potential solutions

Requirements

• Bachelor’s degree in biological sciences or an equivalent relevant discipline
• Minimum 3 years of experience in a cGMP Quality Control role within the biopharmaceutical industry
• Experience with cell and/or gene therapy products is a plus
• Strong analytical, written, and verbal communication skills
• Ability to manage multiple priorities and aggressive timelines
• High level of detail orientation and ability to maintain focus during administrative work

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells.