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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. Leading or participating root cause investigation, deviations, CAPA to ensure efficiency and high-quality level in QC Sample management.

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 Specialist I for QC Sample Management (QCSM) 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 be a part of the Sample Management team who is working in our state of the art 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:

• Keep track of the planning and support the team leaders with daily tasks

• Mentor and train (junior) team members

• Initiate and follow up on Deviations/Changes of the process in a timely manner

• Receive and process QC samples and EM plates

• Perform the Apheresis accession

• Shipment and distribution of samples

• Review of logbooks, forms and other relevant QCSM documents

• Perform supporting assays such as particle isolation

• Perform (small) project independently

Challenges of the Role

• Working in a fast-paced environment

• Keeping the overview

• Improvement of current procedures and workflows

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

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

• Interaction with several department

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. QC experience is a requirement, including basic laboratory techniques. The QC Service department finds team spirit important and therefore open to help out other teams within QC.

• Middelbaar Laboratorium Onderwijs (MLO, Preferable level 4) or similar educational background with at least 3 years QC experience or similar experience.

• Hoger Labortorium onderwijs (HLO/BSc) with at least 2 years of experience.

• Understanding of aseptic techniques

• Strong verbal and technical writing skills (English)

• Organization and prioritization skills

• Handling and reporting change control, deviations, and root cause investigations

• Experience in writing or updating SOPs

• Knowledge of GMP and GDP

• Experience with performing small projects (independently)

Preferred:

• Sample management experience.

• Sample shipment experience.

• Pipetting skills with high precision and accuracy

• Experience using LIMS

Personal skills

• Can-do attitude

• Hands-on, roll up your sleeve’s mentality

• Comfortable in a fast-paced environment

• Strong organizational skills

• Service minded

• Team player

• Flexible

• Excellent communication skills

• Working independently with minimum guidance

Additional Requirements

• Working in shifts (including weekends, early mornings and (late) evenings and bank holidays)

• Work overtime as needed

As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us and discover your sense of purpose.