Quality Control Specialist III (LIMS)

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: May 4, 2025

Job Description:

Quality Control Specialist III (LIMS) page is loadedQuality Control Specialist III (LIMS)Apply locations: United States - Maryland - Frederick; United States - California - Santa MonicaTime type: Full timePosted on: Posted YesterdayJob requisition id: R0045127We'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 fulfill their aspirations. Join Kite and help create more tomorrows.Job DescriptionAs a QC Specialist III supporting the KITE Laboratory Information Management System (KLIMS) program in the Corporate Quality Control (QC) group, this role will work within the Global QC KLIMS team to deliver and maintain KLIMS Global QC master data and provide support to the KLIMS program as needed. The QC Specialist III will help drive global program priorities to achieve established system functionality goals, in addition to managing interactions and communications between site cross-functional personnel (QC, Quality Assurance, Warehouse, IT, etc.) as it relates to QC processes and the global program team. Overall, this role is responsible for providing the technical expertise necessary to communicate and/or support maintenance of the established Global KLIMS program, related processes, and implementation of new system functionality of the Global LabVantage LIMS system as it relates to the Global QC network.This role can be based out of our sites in Frederick, Maryland or Santa Monica, CA and is expected to work West Coast hours.ResponsibilitiesGlobal Related:

• Support and resolve Kite LIMS (KLIMS) issues that impact global operations.
• Provide timely program level reporting on global KLIMS projects and/or Master Data update efforts (e.g., schedule adherence, risk awareness, issue escalation, etc.)
• Serve as coordination and communication conduit for KLIMS related information between site business users, site IT, Site QC KLIMS Administrator and the Global KLIMS Program including but not limited to:
  • Business Process Change Requirements
  • System Outages (planned and/or unplanned)
  • Training Facilitation
  • Issue/Risk Escalation
  • Lessons Learned
  • Review and update global SOPs and WRKs related to KLIMS, as required.
  • Core QC LIMS Administrator oversees system function and use at all sites as they relate to the global processes.
  • Troubleshoot site related KLIMS issues in collaboration with the Site QC KLIMS Administrator and escalate to the global team as necessary.... (additional responsibilities truncated for brevity) ...Basic Qualifications:
    • Master's Degree and 3+ years' experience with LIMS (Lab Information Management Systems) in a GMP environment OR
    • Bachelor's Degree and 5+ years' experience with LIMS (Lab Information Management Systems) in a GMP environment ORPreferred Qualifications:
      • LabVantage (or Sample Manager, LabWare, StarLIMS or similar).
      • Familiarity with data review for routine analytical assays, knowledge of complex analytical methods such as Cell Based Assays, Flow Cytometry, Microbiological assays, PCR is a plus.
      • Experience in sampling, pharmaceutical QC labs, data management, change control, GLP/GMP, and compliance.
      • Understanding of GMPs and 21CFR Part 11 regulations.
      • Excellent technical writing skills for protocols, reports, SOPs.
      • Ability to lead discussions, work independently or in teams, learn new techniques, and manage multiple tasks.
      • Proficiency in Microsoft Office, MS Project, MS Teams, SharePoint, Smartsheets, data analysis software.
      • Strong interpersonal and communication skills.
      • Adaptability to a fast-paced environment with minimal supervision.Does this sound like you? Apply today!The salary range is: $107,185.00 - $138,710.00. Compensation factors include experience, qualifications, and location. Benefits include medical, dental, vision, life insurance, and possibly a bonus and stock incentives. For details, visit: .Kite is committed to diversity and inclusion, providing equal employment opportunities and a harassment-free environment. Applicants needing accommodations can contact .
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Keywords: Gilead Sciences, Inc., Lakewood , Quality Control Specialist III (LIMS), Other , Santa Monica, California