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QC Specialist II

United States - California - San DiegoQualityRegular

Job Description

Job Description

Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies.  We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.  

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.

We are seeking a highly motivated individual to join us as a QC Specialist II.  Reporting to the Manager, Quality Control in Oceanside, CA you will be a hands-on resource for QC Analytical.   Initially as part of the start-up activities, you will be responsible for performing assay validation activities, including being trained on all the Analytical Assays.  As the site transitions into operation, you will primarily be responsible for assay execution for analytical testing utilizing flow cytometry, ELISA, PCR, and cell-based bioassay.  You’ll also contribute to the initiation and completion of quality records associated with analytical testing at the site.

Responsibilities

  • Support assay execution to assess T cell function such as flow cytometry, PCR, Cell based assay
  • Successfully execute and document laboratory procedures and experiments with great attention to detail
  • Contribute to a dynamic, exciting culture that embraces teamwork and innovation
  • Become trained on laboratory procedures including PCR platform, Flow and ELISA
  • Support different AGILE record (CAPA, Deviation, LIR)
  • Assist in reviews data and assists with process trending, and procedural updates.
  • Provides technical support for validation protocol writing.
  • Executes protocols for the qualification and re-qualification of new and current instrumentation.
  • Troubleshoots instruments/methods.
  • Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures.
  • Organize and execute multiple projects in a collaborative team environment
  • Complete routine record review of test data.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory
  • Validates required improvements to current methods. Performs method and equipment validation and training.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Supports the Quality control analytical department by identifying or troubleshooting issues that may affect laboratory or facility monitoring systems or processes and other support to daily QC operations.

Basic Qualifications

  • Master’s Degree and 2+ years of cell Immunotherapy experience
  • Bachelor’s Degree and 4+ years of cell Immunotherapy experience
  • Associate Degree and 5+ years of cell Immunotherapy experience
  • High School Degree and 6+ years of cell Immunotherapy experience


Preferred Qualifications

  • M.S. degree in biology-related field.
  • Expertise in routine laboratory procedures including ddPCR, qPCR, Flow and ELISA
  • Direct experience with cell culture of multiple cell lines and aseptic technique
  • Direct experience with stimulation and in vitro expansion of primary T cells
  • Ability to perform multi-parameter flow cytometric analyses
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description
  • Comfortable in a fast-paced company and able to adjust workload based upon changing priorities
  • Strong organizational skills and record keeping
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Ability to work independently and collaboratively in a team environment
  • Multi-tasking and self-motivated with excellent problem-solving skills
  • Full working knowledge of GMPs, GLPs, pharmacopoeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
  • Project Management and prioritization skills.
  • Audit and Investigation Skills, Report Writing Skills.
  • Strong verbal, technical writing and interpersonal skills are required.
  • Proficiency in Microsoft Office applications.

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