Quality Control Specialist III

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. Would you like to join us in this mission?

We are seeking a highly motivated individual to join us as a Quality Control Specialist III reporting to the Head of Quality Control Technical Services. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.

Responsibilities:

• Implement GMP testing and method qualification/validation using flow cytometry, droplet digital PCR, and ELISA-based methods.
• Author qualification/validation protocols and reports.
• Qualify critical reagents.
• Perform data analysis for validation/qualification activities using Excel.
• Lead method monitoring activities.

• Author Standard Operating Procedures (SOP) and test material specifications.
• Manage site and global quality documents.

Additional job duties include:

• Mange deviations, CAPAs, investigations, and change controls.
• Support routine GMP testing activities.
• Implement worksheet validations.
• Coordinate with Quality Control LIMS Administrator to support quality metrics.
• Partner with Supply Chain to manage reagent cost and usage.
• Lead On the Job Training of Analytical Methods

Basic Qualifications:

• Master’s Degree and 3+ years’ pharmaceutical experience OR
• Bachelor’s Degree and 5+ years’ pharmaceutical experience

Preferred Qualifications

• Experienced in cell and gene therapy.
• Thorough working knowledge of GMP.
• Experienced in Droplet Digital PCR and Flow Cytometry.
• Comfortable in a exciting small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Background in regulatory guidances (e.g., ICH, USP, EP, JP)

Does this sound like you? If so, apply today

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