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QC Specialist III, Logistics Team

Company: Kite Pharma
Location: Santa Monica
Posted on: January 10, 2022

Job Description:

Job DescriptionEveryone 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. Join us in our mission!Kite is seeking a highly motivated individual to join Kite as a QC Specialist III, Global Quality Control, to provide Quality Control support of Global Raw Materials and Reagents Center of Excellence (GRM&R CoE). In this role, you will be responsible for conducting QC sampling and inspection of incoming raw materials, submission of samples to internal and external testing labs, review internal and external testing data and review final raw material packets before submitting to QA for final lot disposition. You will also be responsible for quality system records related to raw materials, such as deviations and CAPAs. This individual will routinely collaborate with other functional groups at Kite, such as Supply Chain, SQM and QA to ensure timely disposition of raw materials in support of production.Responsibilities include (but are not limited to):

  • Perform QC inspection of incoming raw materials and documentation, sampling raw materials and submission to internal and external labs, coordinate shipment of samples to contract labs.
  • As needed, travel to El Segundo site for incoming raw material sampling and inspection.
  • Review final raw material packets and testing data and submit to QA for final lot disposition.
  • Maintain internal and external test results, and work with internal departments on timely raw material release.
  • Assist with tracking of raw materials sample requests to all Kite and 3PL warehouses.
  • Conduct investigations regarding out of specifications (OOS) with contract testing labs and Kite facilities as appropriate.
  • Identify, evaluate, and write investigations for LIRs, OOS's, deviations, CAPAs and Change Controls.
  • Perform risk assessments, gap assessments for analytical methods and aim to enhance compliance and robustness. Ensure process and methods are in compliance with GMP and other regulatory requirements.
  • Compile data for trending or investigation purposes.
  • As needed, perform testing of raw materials by following analytical methods: Compendial methods (pH, Osmolality, Density, Conductivity, etc.)
  • As needed, maintain, calibrate, and operate equipment and instruments supporting in-house raw material testing.
    • Develop, revise, review and approve SOPs as needed for continuous improvements.
      • Support team members with other duties as required, such as gathering documentation and data entry.
      • Participates in regulatory audits as required.
      • Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities, and willing to accept temporary responsibilities outside of initial job description.
      • Organize and execute multiple projects in a collaborative team environment.Basic Qualifications:
        • Master's Degree and 3+ years' experience in the biotech/biopharmaceutical setting OR
        • Bachelor's Degree and 5+ years' experience in the biotech/biopharmaceutical setting OR
        • High School Degree and 9+ years' experience in the biotech/biopharmaceutical settingPreferred Qualifications:
          • Knowledge of current Good Manufacturing Practices (cGMPs), GxP, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry is required.
          • Possesses strong project and time management skills.
          • Experience with compendial methods preferable
          • Working knowledge of cGMP requirements and testing in clinical and commercial QC. Experience with gene and cell therapies preferable. Knowledge of analytical techniques including HPLC, LC-MS, FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents preferred.
          • Experience in identifying, writing evaluating and closing OOS's and investigations.
          • Knowledgeable about Quality Systems (owning LIRs, DEVs, CC, CAPAs, etc).
          • Exceptional attention to detail and ability to keep track of multiple ongoing projects
          • Excellent communication and strong interpersonal skills are required
          • Proficient in MS Word, Excel, PowerPoint, SmartSheet and other applications
          • Ability to perform duties with minimal supervision and must be adaptable to a dynamic and fast-paced environment
          • Excellent interpersonal and organizational skills a must
          • Experience in identifying, writing evaluating and closing OOS's and investigations
          • Experience writing, reviewing, or executing standard operating procedures, test method procedures, protocols, and reports.#QCQA123

Keywords: Kite Pharma, Santa Monica , QC Specialist III, Logistics Team, Professions , Santa Monica, California

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