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QC Specialist II

United States - California - Santa MonicaQualityRegular

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 currently seeking a Quality Control Specialist II to be onsite in Santa Monica, CA.

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 a dynamic, exciting culture that embraces teamwork and innovation
  • Become SME and trainer on laboratory procedures including ddPCR, qPCR, Flow and ELISA
  • Own and manage different AGILE record (CAPA, Deviation, LIR)
  • Reviews data and assists with process trending, and procedural updates.
  • 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.
  • 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

Basic Qualifications

Master’s Degree and 2+ years’ experience in molecular biology, biochemistry, or related field and experience in cell Immunotherapy or related field

OR

Bachelor’s Degree and 4+ years’ experience in molecular biology, biochemistry, or related field and experience in cell Immunotherapy or related field

OR

Associate Degree and 5+ years’ experience in molecular biology, biochemistry, or related field and experience in cell Immunotherapy or related field

OR

High School Degree and 6+ years’ experience in molecular biology, biochemistry, or related field and experience in cell Immunotherapy or related field


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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