Job Directory QC Specialist - LIMS Administrator

QC Specialist - LIMS Administrator
El Segundo, CA

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Job Description

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

Kite is seeking a highly-motivated individual to join us as a Specialist in the Quality Control (QC) Technical Services group. You will work within the commercial QC organization, and have cross-functional interaction with personnel from Clinical QC, Quality Assurance, Manufacturing and Corporate teams.

In this position, you will have an overall responsibility, among others, of providing technical expertise for the implementation, maintenance, and optimization of the LabVantage LIMS system. You'll also coordinate with the site LIMS Administrator as well as the Corporate LIMS team and the IT function.

Key Responsibilities include (but are not limited to):

* Link laboratory programs to LIMS for data upload, as well as continuously improve upon IT processes. Analytical to reduce turnaround time while also maintaining quality system requirements
* Manage and maintain LIMS static data such as user matrix, specifications, analysis, stability protocols, data tables and instruments
* Interact with the Laboratory operations group to support LIMS implementation and ongoing support.
* Work with the IS and IT groups to integrate LIMS in a cGMP environment.
* Independently plan, manage and execute assignments, contribute to project planning meetings
* Support all necessary aspects of LIMS projects and operations as assigned
* Partner with IT and laboratory organizations, support users by responding to change requests and training needs
* Assist in developing and maintaining Standard Operating Procedures (SOPs) for global and local Laboratory Information Management (LIMS) Systems
* Act as key project team member for new systems implementations and/or installation of new capabilities
* Provide system oversite activities including audit trail reviews, system reviews, resolution of problem reports, data maintenance as applicable
* Author protocols and technical documents and provide summary reports from LIMS
* Proactively communicate issues to key stakeholders to ensure a timely resolution and escalate as needed to ensure corporate timelines are met.
* Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues.
* Proactively seek out senior collaborators to discuss potential solutions to problems. Ability to clearly present results of work, interpret data and draw conclusions.
* Work collaboratively with cross functional departments to manage project activities
* Select, install and troubleshoot instruments devices
* Perform other duties as assigned as on need basis


* Bachelor's degree with 6+ years of experience, preferably in a GMP environment or Master's degree with 4+ years of experience, preferably in a GMP environment.
* Experience with a Lab Information Management System (LabVantage, Sample Manager, LabWare, StarLIMS or similar).
* Demonstrated success implementing LIMS and computer system validation in a cGMP environment
* Familiarity with data review for analytical methods such as Cell Based Assays, Flow Cytometry Assays, Microbiological assays, PCR and other routine analytical assays.
* Experience in areas such as sampling, pharmaceutical quality control lab, 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
* Ability to communicate complex scientific findings and recommendations in one-on-one discussions and departmental meetings.
* Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs.
* Ability to work independently and 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, 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 small company environment with minimal direction and able to adjust workload based upon changing priorities



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 Sign up to follow @KitePharma on Twitter at

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.




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 Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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