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Sr QC Microbiology Tech

United States - California - San DiegoQualityRegular

Job Description

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. Join us in our mission!

We are seeking a highly motivated individual to join us as a Sr QC Microbiology Tech.

You will be located at our Oceanside, CA site.

Key Responsibilities (include but are not limited to):

  • Support the transfer and validation of microbiological methods to Oceanside, CA.
  • Conduct investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures.
  • Develop, revise and review SOPs, qualification/validation protocols and reports.
  • Generate trend reports on environmental monitoring and product release data. Frequently update management on trends. Implement corrective action plans when necessary.
  • Receive and maintain traceability and integrity of test samples, reagents and materials used in the laboratory per approved procedures
  • Perform environmental monitoring of cleanrooms, including air and gas sampling
  • Perform water sample collection and testing
  • Perform material, in-process and final product microbiological assays such as Gram Stain, Endotoxin, Sterility, Microbial Identification, Growth Promotion, Bioburden and Plate Reading

Basic Qualifications:

Master’s Degree and 2+ years of experience in GMP quality control or manufacturing

OR

Bachelor’s Degree and 4+ years of experience in GMP quality control or manufacturing

OR

Associate Degree and 5+ years of experience in GMP quality control or manufacturing

OR

High School Degree and 6+ years of experience in GMP quality control or manufacturing

Preferred Qualifications:

  • Bachelor of Science degree in microbiology, biochemistry, or related life science
  • Strong initiative and enthusiasm to complete ambitious tasks and learn new technologies related to CAR T products and viral vector manufacturing.
  • Strong understanding of applicable USP, ICH, and Ph Eur regulations related to intermediate, release, and stability testing.
  • Excellent verbal and written communication skills.
  • Experience with scheduling, testing, and data review data of QC environmental monitoring and microbiology assays for raw materials, in-process, release, and stability samples.
  • Experience in the assessment of product sterility, aseptic manufacturing processes, and facilities for microbial risk.
  • Experience with QMS systems including OOT/OOS/invalid investigations and working cross-functionally to support CAPA and proactive initiatives.
  • Experience training and mentoring laboratory analysts, with a focus on team building.
  • Experience troubleshooting analytical equipment and methods.
  • Ability and desire to work in a fast-paced environment, manage large projects and implement microbiology programs.
  • Experience interacting with hosting internal and external auditors is preferred.