Full Job Description
Job Description
We are seeking a highly motivated individual to join us as a Quality Control Operation Specialist I reporting to the QC analytical Sr Manager. You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
As a QC Operations Specialist I at Gilead/Kite you will ...
- Perform drug substance lot release, in-process, and stability testing in a GMP environment, including PCR, cell-based assays, flow cytometry and RVV/LVV stability testing.
-Execute routine laboratory testing in a GMP environment and accurately document results using KLIMS, demonstrating the ability to navigate the system effectively.
- Perform routine sampling and sample management activities, including sample aliquoting, shipping, and external submissions, while maintaining sample integrity, traceability, and chain of custody.
-Manage daily sample and reagent operations, including inventory control, organization, and traceability in compliance with GMP/GDP requirements.
- Conduct laboratory maintenance activities, including biosafety cabinet (BSC) cleaning, equipment cleaning, general lab upkeep, media preparation, reagent ordering, and laboratory stocking.
- Adhere to all GMP and GDP standards, site procedures, and safety requirements to ensure compliance and data integrity.
- Serve as a signed-off reviewer for assigned documentation in accordance with training.
- Assist in the execution of validation and verification activities following approved protocols and procedures.
- Support quality system activities, including assistance with deviations, CAPAs, change actions, and other quality records under supervision.
- Assist in the assembly and maintenance of data trending reports, including Quality Control Metrics to support continuous improvement and compliance monitoring.
- Participate in and support training activities, including completion of required training and assistance with training documentation as needed.
- Support document revision activities with appropriate oversight.
-Capability to lift and move items weighing up to 50 lbs on an occasional basis
- Perform additional duties as assigned.
The salary range for this position is: $80,325.00 - $103,950.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
