Quality Assurance Specialist I

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: April 7, 2025

Job Description:

Job DescriptionWe'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 DescriptionWe 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 Kite's RDMC manufacturing site. The Quality Assurance Specialist will ensure compliance with the quality system's 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 in-process controls 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 batch-related 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 product-related 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, in-process 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 fast-paced 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
    • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
    • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environmentDoes this sound like you? If so, apply today!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.
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Keywords: Gilead Sciences, Inc., Santa Monica , Quality Assurance Specialist I, Other , Santa Monica, California