Quality Control Specialist III

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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 Gilead and help create possible, together.

Job Description

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a QC Specialist III at Gilead, you will support Quality Control laboratory operations through the administration, enhancement, integration, and continuous improvement of QC computerized systems and digital solutions. You will also serve as a technical resource for laboratory informatics, instrumentation software, data analytics, system lifecycle management, and digital transformation initiatives. This role collaborates cross-functionally to implement innovative technologies that improve data integrity, compliance, operational efficiency, and laboratory productivity in a GMP-regulated environment.

This is a site-based position (Monday- Friday) in La Verne, CA.

Specific Job Responsibilities:

• Provide technical troubleshooting and support for laboratory instrumentation and computerized systems.
• Identify process improvement opportunities and recommend solutions to enhance performance, compliance, and user experience.
• Interact with vendors to evaluate technologies, resolve technical issues, and support implementation activities.
• Monitor industry trends, emerging technologies, and best practices related to laboratory digitalization and QC informatics.
• Support computerized system validation activities including URS, risk assessments, test protocols, reports, and lifecycle documentation.
• Ensure systems remain compliant with applicable regulatory and data integrity requirements.
• Participate in change controls, deviations, CAPAs, periodic reviews, and audits.
• Support qualification and requalification activities for laboratory instrumentation and computerized systems.
• Partner with IT, Quality, and business stakeholders to identify and implement technology improvements.
• Drive adoption of innovative technologies including automation, artificial intelligence, advanced analytics, and digital workflows.

Knowledge:

• Strong understanding of laboratory informatics, computerized systems, and digital technologies.
• Experience with laboratory applications including LIMS, ELN, instrumentation software, and data visualization tools.
• Knowledge of AI, automation, digitalization, and emerging technologies applicable to pharmaceutical Quality Control laboratories.
• Experience developing, modifying, or utilizing scripts, queries, or code to automate laboratory processes, transform data, generate metrics, or integrate laboratory systems is preferred.
• Working knowledge of GMPs, GLPs, Data Integrity (ALCOA+), 21 CFR Part 11, Annex 11, and applicable regulatory requirements.
• Understanding of computerized system lifecycle concepts including validation, qualification, change management, and periodic review.
• Knowledge of analytical instrumentation and laboratory workflows.
• Strong project management, prioritization, and problem-solving skills.
• Excellent technical writing, communication, and interpersonal skills.
• Proficiency in Microsoft Office applications, data analytics, and reporting tools.
• Experience with system integration and data connectivity between laboratory instruments and enterprise systems is preferred.

Specific Education & Experience Requirements:

• 5+ years of relevant experience and a BS or BA OR
• 3+ years of relevant experience and a MS

Preferred:

• Prior experience in pharmaceutical industry is preferred

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