QC Specialist II

Kite Pharma • Santa Monica, CA

4d

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.

Requirements

• Bachelor’s degree with at least 4 years , or Master’s degree with at least 2 years , of hands‑on laboratory experience in a biotech or biopharmaceutical setting.
• Experience working in a GMP or regulated environment .
• Ability to work independently and manage multiple projects simultaneously.
• Strong oral and written communication skills and demonstrated interpersonal effectiveness.

Nice To Haves

• Hands‑on experience with biological and biochemical analytical methods , including pH, osmolality, conductivity, visual inspection, and protein assays.
• Experience with ELISA, qPCR, ddPCR , and flow cytometry (e.g., FACS Canto, CytoFlex).
• Experience performing safety and microbiological assays , including mycoplasma and endotoxin testing .
• Experience supporting QC equipment qualification, validation, and system administration in GMP laboratories.
• Familiarity with quality systems including Deviation, CAPA, Change Control, OOS, and OOT investigations.
• Strong attention to detail with a continuous improvement mindset.

Responsibilities

• Lead method transfers to support accelerated timelines for early clinical pipelines and internal product lines, partnering with cross‑functional teams across Analytical Development, site QC, and external sites as needed.
• Perform routine equipment audits and system backups to ensure data integrity and system availability.
• Serve as System Administrator , managing user access, security, and permissions for GMP laboratory systems.
• Collaborate with cross‑functional partners (Facilities, Engineering, IT) on the maintenance, qualification, and operation of QC laboratory equipment and systems .
• Act as a QC representative for specialized areas during site‑level meetings and initiatives.
• Support and participate in internal, external, and regulatory inspections , including preparation and direct inspection support.
• Resolve data discrepancies and missing information to support continuous quality improvement.
• Develop, revise, review, and maintain SOPs, qualification/validation protocols, and technical reports .
• Monitor GMP laboratory systems to ensure compliance with documented policies, procedures, and regulatory requirements.
• Provide on‑the‑job training and day-to-day technical guidance to QC Lab Services staff under appropriate supervision.
• Perform QC sample receiving, processing, storage, distribution, and disposal in compliance with GMP requirements.
• Gather quality metrics and perform trend analysis to identify opportunities for improvement.
• Support ad‑hoc projects and additional duties as assigned.
• Conduct and support OOS, OOT investigations , Deviation investigations, CAPAs, and Change Controls related to QC equipment and system management.
• Serve as Point of Contact (POC) for internal and external inspections related to QC equipment and systems.
• Work independently with minimal supervision; proactively identify, troubleshoot, and communicate issues to stakeholders.
• Use strong verbal and interpersonal communication skills to provide technical insight and achieve assigned objectives.
• Maintain a strong commitment to lab safety , supporting a goal of zero OSHA recordable incidents .
• Work flexible hours across a seven‑day workweek, including overtime, weekends, or holidays , as operational needs require.
• Perform physical activities including lifting up to 25 lbs and working with dry ice and LN₂ freezers .
• Delegate responsibilities to qualified deputies, as appropriate.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees