QC Specialist I

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Key Responsibilities (include but are not limited to):

• Serve as SME on assigned QC Lab Support processes including LIMS.
• Receive incoming samples, verify documentation, and log sample information into LIMS.
• Execute processes to support sample receipt and processing or aliquoting for release/stability testing and retains.
• Label, store, and organize samples according to established procedures and storage requirements.
• Coordinate sample transfers to internal and external testing labs.
• Perform routine cleaning, maintenance, and restocking of sample storage areas.
• Collaborate with MM, QA, and other QC functions—including Corporate QC—to support requirements around Raw Material sampling, testing, and disposition.
• Manage and complete all shipping activities within QC functions.
• Complete routine review of records, such as sample chain of custody forms, processing logs, logbooks, and other documentation generated within QC Lab Support.
• Conduct training on assigned QC processes.
• Author controlled documents such as SOPs, forms, etc., as needed.
• Assist with deviation, investigation, CAPA and change control activities as needed.
• Provide updates during daily and weekly meetings.
• Participate in Lean Lab and other Operational Excellence initiatives.
• Comply with all safety, quality, and regulatory guidelines.
• Perform other duties as assigned.

Basic Qualifications:

• Bachelor’s Degree and at least 2 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory OR
• Associate Degree and at least 4 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory OR
• High School Degree and at least 5 years of experience working in Quality Control or biopharma laboratories preferably in a FDA regulated laboratory.

 

Preferred Qualifications:

• Thorough knowledge in applying GMP in QC lab.
• Exceptional attention to detail and ability to keep track of multiple ongoing projects
• Proficient in Microsoft Office, Excel, Visio, and other related applications
• Ability to effectively negotiate and develop collaboration within teams and amongst team members.
• Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment
• Comfortable in a fast-paces small company environment with minimal direction and able to adjust workload based on changing priorities.

Shift:

Sunday to Wednesday morning shift 3p-2a (NIGHT SHIFT)

 

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.