QA Specialist I

Job Description

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.

Key Responsibilities (included but not limited to):

• 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

Basic Qualifications:

• 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

Preferred Qualifications:

• 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

The salary range for this position is: $80,325.00 - $103,950.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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.

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. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.