
Sr QC Microbiology Tech
United States - California - San DiegoQualityRegularJob 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.