QC Specialist - LIMS Administrator

Employer
Kite Pharma
Location
El Segundo, CA, United States
Posted
Sep 11, 2019
Ref
R0008352
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
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


Qualifications
  • 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


#LI-MY1

IND123

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. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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