QC Specialist II

职位描述

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

We are seeking a highly motivated individual to join us as a Quality Control Specialist II 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 Specialist II, at Gilead/Kite you will ...

Key responsibilities

• Execute the transfer and validation of analytical methods to Oceanside, CA, QC.

• Provide Training on Analytical methods.

• Perform drug substance lot release and in-process testing and stability using PCR, cell-based assays and/or flow cytometry (multiple colors preferred) in a GMP environment.

• Provide support for assay performance and troubleshooting of analytical issues in the context of a GMP laboratory.
• Experience using “LIMS” lab information management System.

• Support deviations, investigations, CAPAs and change control activities and Laboratory Investigations/OOS.

• Assist in establishing user requirements for purchase and qualification of Kite’s QC analytical equipment and materials/reagents.

• Work with internal and external resources to maintain equipment in an optimal state.

• Develop, revise and review SOPs, test methods and work instructions.

• Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies.

• Support and participate in regulatory agency inspections.

• Assist with daily sample and reagent management activities such as receipt, aliquoting, organization, inventory control, and maintaining traceability in accordance with GMP/GDP expectations
• Identify and lead teams for lean improvement activities.

• Up to 10% domestic travel

• Capability to lift and move items weighing up to 50 lbs on an occasional basis.

• Additional duties as assigned.

Basic Qualifications:

• Master’s Degree and 4+ years’ pharmaceutical experience OR

• Bachelor’s Degree and 6+ years’ pharmaceutical experience

Preferred Qualifications

• Experienced in cell and gene therapy.

• Strong working knowledge of GMP.

• Strong background in Flow Cytometry testing and sound knowledge of Flow Cytometry scientific principles.

• Strong background and knowledge in Droplet Digital PCR testing.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.