Quality Assurance Specialist I

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were 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

We are seeking a highly motivated individual who is a team player and has a mindset of growth contribution and continuous improvement to join us as a Quality Assurance Specialist I at Kites RDMC manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality systems procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives.

Responsibilities (included but not limited to):

• Provide QA support on the floor for production of autologous patient lots and collaborate with Manufacturing and Process Development
• Ensure inprocess control are followed in product manufacturing
• Receipt and disposition of incoming apheresis material.
• Oversee and authorize shipment of final product
• Verify and ensure timely issuance of production documents and labels
• Review batchrelated documentation and ensure resolution of issues to release and ship product.
• Gather and report metrics to measure performance
• Identify continuous improvement actions
• Ensure timely resolution and escalation of issues
• Ensure all productrelated Deviations are initiated investigated and resolved.
• Ensure that associated CAPAs are initiated and resolved as needed.
• Perform lot closure activities.
• Ensure approval and timely delivery of final product.
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Provide Quality Assurance support resolving material inprocess product final product environmental facility and equipment manufacturing issues.
• Perform other duties as assigned
• This role supports a dynamic clinical environment that supports patients worldwide

(This position will require flexibility and weekend/holiday support)

Basic Qualifications:

• MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) OR
• BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2 years of Quality experience or experience in a GMP environment (Drug Substance or Drug Product) OR
• Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 4 years of Quality experience or experience in a GMP environment (Drug Substance or Drug Product)

Preferred Qualifications:

• BS/BA 2 yrs. experience in a GMP related field within a biotechnology biologics or pharmaceutical manufacturing facility
• Working knowledge and ability to apply GMPs in conformance to U.S. EU and ROW standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Strong teamwork and collaborative skills
• Experience with manufacturing investigations deviations and CAPA.
• General knowledge of aseptic manufacturing processes
• Experience with handling and propagation of human primary cells including T cells and/or cell culture processing experience
• Previous experience with cell therapy products is a plus
• Proficient in MS Word Excel Power Point and other applications
• Strong interpersonal verbal and written communication skills
• Comfortable in a fastpaced environment and able to adjust workload based upon changing priorities
• Willingness to think outside of the box and adapt best practices to a small but growing environment
• Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational prioritization and time management proficiencies
• Selfmotivated detailoriented and willing to accept temporary responsibilities outside of initial job description
• Excellent interpersonal verbal and written communication skills are essential in this collaborative work environment
  Comfortable in a fastpaced small company environment with minimal direction and able to adjust workload based upon changing priorities

Does this sound like you If so apply today!

For additional benefits information visit:

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 longterm 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 systems ability to recognize and tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob related characteristics or other prohibited grounds specified in applicable federal state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

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