Quality Control Specialist III

About the role

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

Pay and benefits

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 QC laboratory operations experience across: administration, enhancement, integration, and continuous improvement of QC computerized systems and digital solutions strongly preferred Gilead's People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account.

They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $107,185.00 - $138,710.00. Gilead 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*.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.