QC Lab Ops Specialist I

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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 QC Lab Ops Specialist I , Quality Control.  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 validation assay including being trained on all the Analytical Assays.  As the site transitions into operation, you will be responsible for assay execution for analytical testing utilizing flow cytometry, ELISA, PCR, and cell-based bioassay. 

Additional Responsibilities (include but are not limited to):

• Train on Analytical Assays including flow cytometry, ELISA, PCR, and Cell Based assay.
• Assist in authoring and revising processes and procedures for analytical method and associated work streams.
• Training and maintaining QC equipment in collaboration with method subject matter experts, conduct weekly, monthly and quarterly check for QC analytical lab instrument.
• Support validation activities in alignment with established timelines.
• Support deviations, investigations, CAPAs and change control activities as needed.
• Participate in teams for lean improvement activities.
• Maintaining the lab in a state of Audit readiness and Support inspection readiness activities.
• Monitors biohazardous waste and coordinates its removal with qualified safety personnel.
• Assist in managing samples in logbooks and LIMS (Laboratory Information management system) when submitted to QC laboratory.
• Support regulatory filings and response to questions.
• Other duties as required.

Basic Qualifications:

Bachelor’s degree

OR

Associate Degree and 2+ years of experience in cell immunotherapy

OR

High School Degree and 3+ years of experience in cell immunotherapy

Preferred Qualifications:

• Experience with Labvantage LIMS and other quality systems.
• knowledge of cGMPs.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.

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