Quality Control Specialist III
About The Position
At Gilead, the Quality Control Specialist III supports Quality Control laboratory operations through the administration, enhancement, integration, and continuous improvement of QC computerized systems and digital solutions. The role serves as a technical resource for laboratory informatics, instrumentation software, data analytics, system lifecycle management, and digital transformation initiatives. It collaborates cross-functionally to implement technologies that improve data integrity, compliance, operational efficiency, and laboratory productivity in a GMP-regulated environment. This is a site-based position in La Verne, California, Monday through Friday.
Requirements
- 5 or more years of relevant experience and a BS or BA, or 3 or more years of relevant experience and an MS.
- 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.
- 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.
Nice To Haves
- Experience developing, modifying, or using scripts, queries, or code to automate laboratory processes, transform data, generate metrics, or integrate laboratory systems.
- Experience with system integration and data connectivity between laboratory instruments and enterprise systems.
- Prior experience in the pharmaceutical industry.
- QC laboratory operations experience in the administration, enhancement, integration, and continuous improvement of QC computerized systems and digital solutions.
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, 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.
Benefits
- Discretionary annual bonus eligibility.
- Discretionary stock-based long-term incentives; eligibility may vary by role.
- Paid time off.
- Company-sponsored medical, dental, vision, and life insurance plans.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
