QA Specialist I - Operations Review & Disposition

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

Department: QA Operations Review & Disposition

Position: QA Specialist I – Operations Review & Disposition

Your responsibilities

• Reviews – both in paper and electronic record format - manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.
• Identifies and reports deviations or other departures from approved processes and procedures to senior colleagues.
• Performs a variety of activities to ensure compliance with applicable regulatory requirements.
• Additional duties as assigned, these duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Your profile

• Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates good verbal, written, and interpersonal communication skills.
• Demonstrates working knowledge in Microsoft Office applications.
• Demonstrates familiarity and comfort with computerized (e.g. ERP/EBR/LIMS) applications in support of manufacturing record reviews.

Education & Experience

• BSc and 2+ years of experience in a GMP environment OR
• 3+ years of experience in a GMP environment and Associated degree / diploma
• Prior experience in Pharmaceutical industry or similar biotechnology industry is beneficial.

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.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit, select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

Change The World With Us

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted. While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.