Kite

Actively Hiring

Quality Assurance Specialist

El Segundo, United States

Full time

Role Overview

Review batch-related documentation, ensure resolution of issues to release product, and perform comprehensive quality review of batches for disposition.

About Kite

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.

Key Responsibilities

Review batch-related documentation and ensure resolution of issues to release product.
Perform comprehensive quality review of batches for disposition.
Ensure process control measures are in place and followed in product manufacturing.
Ensure all product-related Deviations are initiated, investigated and resolved.
Ensure that associated CAPAs are initiated and resolved, as needed.
Generate and update procedures, forms and other documents.
Manage and provide QA oversight for other processes, including training, warehouse /inventory, redose, new product introductions, etc.

Requirements & Eligibility

Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, or a related scientific discipline.
Minimum 3-4 years of experience in a regulated pharmaceutical, biotechnology, cell therapy, medical device, or GMP manufacturing environment.
Working knowledge of cGMP regulations, FDA requirements, and applicable quality systems.
Experience reviewing and approving GMP documentation, including batch records, deviations, CAPAs, change controls, and investigations.

Required Skills & Tech

cGMPFDA requirementsMicrosoft OfficeVeeva VaultMESSAP