Job Description
AtGileadour 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 world27s 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
- QC laboratory operations experience across: administration, enhancement, integration, and continuous improvement of QC computerized systems and digital solutions strongly preferred
Gilead27s People Leader Accountabilities:
- Create Inclusion -knowingthe 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 employeesare receivingthe feedback and insight needed to grow,developand realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizationalobjectives, 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*.
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.
