QC Specialist III – LIMS Administrator

Gilead Sciences, Inc.; Santa Monica (CA); On-site; USD 107,000 - 139,000; Full time

Job summary

An innovative biopharmaceutical company is seeking a KLIMS Administrator to enhance cancer therapies. In this pivotal role, you will manage and support the Global Raw Materials and Reagents group, ensuring the smooth operation of the KLIMS system. Your expertise will drive global program priorities, facilitate communication across teams, and maintain master data related to raw materials. This position offers a unique opportunity to contribute to groundbreaking cancer treatments while working in a collaborative and inclusive environment. If you're passionate about making a difference in the fight against cancer, this role is for you!

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Qualifications

• 3+ years of experience with LIMS in a GMP environment.
• Excellent technical writing skills in a regulatory environment.

Responsibilities

• Act as the primary KLIMS point of contact for QC raw materials.
• Provide timely reporting on raw material and KLIMS projects.
• Support inspections and audits for KLIMS-related topics.

Skills

LIMS (Lab Information Management Systems)

GMP environment

Analytical methods

Technical writing

Microsoft Office

Communication skills

Education

Master’s Degree

Bachelor’s Degree

Tools

LabVantage

MS Project

MS Teams

SharePoint

Smartsheets

Job description

Job Description

We’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 fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

As a KITE Laboratory Information Management System (KLIMS) Administrator in the Global Raw Materials and Reagents (GRM&R) group, this role will work with the Global QC KLIMS Administrator to deliver and maintain KLIMS master data related to raw materials and provide support to site QC KLIMS Administrators as needed. The GRM&R KLIMS Administrator will help drive global program priorities to achieve established system functionality goals, in addition to managing interactions and communications between global and site cross-functional personnel (QC, Quality Assurance, Warehouse, IT, etc.) as it relates to raw materials and the global program team. Overall, this role is responsible for providing the technical expertise necessary to communicate, plan, and/or manage maintenance of established raw material Master Data and implementation of new system functionality of the Global LabVantage LIMS system as it relates to the raw material network.

This role is based out of our site in Santa Monica, California, and is expected to work primarily on site.

Responsibilities

Global Related:

• Primary KLIMS point of contact at all sites for the QC raw materials network and global program
• Provide timely program level reporting on active raw material and other global KLIMS projects and/or Master Data update efforts (e.g. schedule adherence, risk awareness, issue escalation, etc.)
• Active participation in global, vertical specific, working and delivery teams
• Provide required input/feedback to ensure a successful evaluation and delivery of program enhancements
• Collaborate with QC KLIMS Admin Team to share raw material network specific knowledge and identify opportunities for improved global management and alignment of KLIMS application
• Coordinate and provide raw material network feedback related to outage options to KLIMS IT team and organize meetings with QC and warehouse leadership as necessary to resolve outage timing questions/concerns
• Execute Master Data updates/changes related to raw materials as they arise
• Support inspections/audits for KLIMS specific topics, requests, or questions
• Provide global Change Control support, as required. Including but not limited to Master Data and/or technical impact assessments
• Provide peer review support of Master Data updates generated by other QC KLIMS Admins and backup support for other sites as needed
• Review and update global SOPs and WRKs related to LIMS, as required
• Other ad hoc GRM&R KLIMS projects and support as needed

Site Related:

• Core QC LIMS Administrator oversees system function and use at all sites as they relate to the raw material process
• Support and resolve raw material KLIMS issues that impact current operations
• Support training and use of KLIMS for each function at the site
• Obtain cross-functional alignment on raw materials KLIMS related project requirements and resources to facilitate implementation and ongoing support
• Serve as coordination and communication conduit for KLIMS related information between site raw materials 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
• Generate any site-specific raw materials Master Data to support KLIMS functionality rollout at each site
• Support raw material QMS records (i.e. DEV, CAPA, CC) related to KLIMS in collaboration with the appropriate site QC KLIMS Administrator
• Troubleshoot site related raw materials KLIMS issues in collaboration with the site QC KLIMS Administrator and escalate to the global team as necessary
• Assist in developing, reviewing, and maintaining site specific, KLIMS related documentation (SOPs, WRKs)
• Collect improvement opportunities and associated requirements from the business and escalate to the appropriate global working team
• Participate in KLIMS maintenance and system upgrade activities.
• Work with local business partners to raise enhancement requests and support business case development.

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 OR

Preferred Qualifications:

• LabVantage (otherwise Sample Manager, LabWare, StarLIMS or similar).
• Familiarity with data review for routine analytical assays commonly performed on raw materials; knowledge of more complex analytical methods such as Cell Based Assays, Flow Cytometry Assays, Microbiological assays, PCR is a plus.
• Experience in areas such as sampling, pharmaceutical quality control, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance.
• General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations
• Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs.
• Ability to lead complex topics in discussion, work independently, and/or as part of a team with internal and external teams
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Excellent skills in Microsoft Office, MS Project, MS Teams, SharePoint, Smartsheets, data analysis software, and other related applications
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

Does this sound like you? If so, apply today!

The salary range for this position is: $107,185.00 - $138,710.00. Kite 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.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.