QC Associate

Job Description

Job Description

We are seeking a highly motivated individual to join the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. In this role you will help provide Quality Control oversight of commercial manufacturing of final drug product. You will be working in the sample chain of custody area on the following: Sample management / particle isolation / shipment / Apheresis accession and much more.

Kite, A Gilead Company

At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.

We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

Department Description

As QC associate for Sample Management, you’ll be joining a team in which people of all backgrounds and experiences are respected, and working together focused on saving lives, by finding the cure for cancer, is a daily activity.

QC Sample management is a unit within the QC Services Department. QC Services is a service unit providing services involving Data management, LIMS support, Sample Management, material management of the Laboratories, Incoming Goods sample management and laboratory equipment lifecycle management. The team is diverse, enthusiastic and hard working.

You’ll be reporting to the QC Team Lead Sample management.

Your Responsibilities

In this role, you will ensure support of high quality for Quality Control and operations while ensuring compliance of protocols, GXP and safety regulations. Due to the nature of the treatment, this role requires high level of proficiency and ownership of the process, with the highest skill of aseptic techniques and precision. You will participate in the sample management laboratory of the manufacturing site and make a substantial contribution to our treatment and the growth and development of Kite Pharma.

Your responsibilities, among others, will be:

• Receive of QC samples and environmental monitoring plates

• Processing QC samples (Centrifuge, aliquot by pipetting)

• Distribution of QC samples to QC labs

• Shipment of samples

• Develop, revise and review procedures

• Housekeeping of sample management area

• Review of logbooks, forms and other relevant QCSM documents.

• Perform the Apheresis accession (Starting material release).

• Perform routine maintenance of lab equipment and lab areas

• Perform supporting assays such as particle isolation.

• Perform other duties as required

Challenges of the Role

• Working in a fast-paced environment

• Improvement of current procedures and workflows

• Timely processing of a continuous sample flow at a high pace

• High quality with a minimum of deviations (First time right)

• Interaction with several department and keeping the overview

Your Profile

The ideal candidate for this position, has a hands-on mentality and thrives in a fast-paced environment. At sample management a strong sense of organization is required to ensure that the sample flow is not compromised. The ideal candidate must be willing to work in shifts and overtime when needed. Basic laboratory techniques are required and preferable QC experience. The QC Service department finds team spirit important and therefore open to help out other teams within QC.

• MLO/ BSc or similar educational background;

• Understanding of aseptic techniques and knowledge of GMP and GDP;

• Knowledge and/or experience in sample management and shipment;

• Proficiency in Microsoft office applications;

• Pipetting skills with high precision and accuracy is required.

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