QA Specialist I

Kite Pharma•Santa Monica, CA

11d

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Quality Assurance Specialist I Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day‑to-day work. Would you like to join us in this mission? We are seeking a highly motivated individual to join us as a Quality Assurance Specialist I. In this role, you will support activities of the Quality Assurance department within the Global QA organization, supporting the Global Raw Materials and Reagents Center of Excellence (GRM&R CoE). The Quality Assurance Specialist I is responsible for supporting compliance with the quality system, identifying and assessing regulatory and quality risks, and providing day‑to-day QA oversight of raw material and reagent processes within GRM&R.

Requirements

Bachelor’s degree (BS) with a minimum of 2 years of relevant experience in a GMP‑regulated environment
Associate’s degree (AA) with a minimum of 4 years of relevant experience in a GMP‑regulated environment
Prior experience in the pharmaceutical or biotechnology industry is beneficial

Nice To Haves

Working knowledge of GMP requirements and ability to apply GMP principles in conformance with U.S., EU, and Rest‑of-World regulations
Experience supporting manufacturing or laboratory investigations, deviations, and CAPAs
Strong interpersonal, verbal, and written communication skills
Ability to collaborate effectively and build productive working relationships across teams
Proficient in Microsoft Word, Excel, PowerPoint, and other standard business applications
Comfortable working in a fast‑paced environment with the ability to adjust workload based on changing priorities
Demonstrated organizational, prioritization, and time‑management skills while managing multiple assignments
Self‑motivated, detail‑oriented, and willing to take on temporary responsibilities outside of the initial job description
Willingness to adapt best practices to evolving processes and business needs

Responsibilities

Perform a wide variety of activities to ensure compliance with applicable quality objectives, regulatory requirements, and GMP guidelines
Provide QA support through review and approval of raw material batch disposition records
Review batch‑related documentation, ensure resolution of issues, and support timely release and shipment of raw materials
Ensure approval and timely release of raw materials to the Global Network
Verify and ensure timely issuance of production and testing documentation
Ensure process control measures are in place and followed for raw material testing and provide guidance to laboratories on adherence to controls
Provide document control support, including issuance of testing forms for the site/laboratory and maintenance of electronic document organization and alignment
Ensure all raw material‑related deviations are initiated, investigated, and appropriate CAPAs are developed and completed
Serve as Quality Approver on quality records, including LIRs, deviations, and CAPAs
Gather, trend, and report metrics to measure performance and support continuous improvement activities
Identify and support continuous improvement initiatives within QA
Ensure timely resolution and appropriate escalation of quality issues
Participate in the development and maintenance of Standard Operating Procedures (SOPs) to ensure quality targets are met
Participate in the development and execution of QA training activities
Perform other duties as assigned

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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