QA Lab Associate CAR-T

We fynd; Beerse; Sur place; EUR 42 000 - 62 000; Plein temps

Avantages offerts par ce poste

Maaltijdcheques

Woon-werk verkeer

Hospitalisatieverzekering

Groepsverzekering

Pensioensparen

Vakantiegeld

13de maand

Résumé du poste

Janssen Supply Chain Group in Beerse, België zoekt een QA Lab Associate CAR-T voor kwaliteitsbewaking van release testing in een GMP-omgeving. De kandidaat werkt mee aan QC-labs (microbiology/biotechnology), SOP’s, procedures en CAPA-activiteiten.

De rol vereist een Master in engineering/wetenschap, ervaring in GMP-kwaliteitswaarborging en kennis van microbiologie en biotechnologie. Flexibele werktijden en doorgroeimogelijkheden worden geboden.

Qualifications

• Mastergraad in engineering, wetenschap of gelijkwaardige technical gebied.
• Ervaring met QA in een GMP-omgeving is een plus.
• Ervaring met microbiologische testen is gewenst.
• Ervaring met biotechnologische methoden zoals flow cytometry, qPCR, ELISA is gewenst.
• Ervaring met celcultuur is gewenst.

Responsabilités

• Toezicht houden op QC-labs voor release testing van CAR-T-producten volgens Janssen-procedures en cGMP.
• Ondersteunen bij kwaliteits- en instrumentkwalificatie van labapparatuur.
• Bijdragen aan SOP-drafting en goedkeuring.
• Uitvoeren van spot-checks in het QC-lab om naleving vast te stellen.

Connaissances

Master degree or hoger

GMP QA ervaring

Microbiologische testing

Flow cytometrie

qPCR

ELISA

Celcultuur

Formation

Master of Science in Engineering/Science

Description du poste

Functiebeschrijving

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab associate for the CAR-T hub in Europe. The position will be based in Beerse Belgium.

CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which works by harnessing the power of a patient’s own immune system. The patient’s own T cells are harvested and engineered to kill the cancer cells expressing a specific antigen.

To bring this life-saving therapy to the patients, Janssen is looking for new talents to support the QA Lab organization! So don't hesitate the patients are waiting!

The QA Lab Associate CAR-T is responsible for providing quality oversight for the release testing CAR-T cellular therapy products in accordance with Janssen policies, standards, procedures, and Global cGMP’s.

• Provide compliance oversight for the QC release laboratories (microbiology and biotechnology), ensuring accurate and timely review of laboratory investigations, performing analysis on quality indicating data and identifying any trends noted for QC data.


• Provide compliance and quality oversight for Lab instrument qualification


• Support drafting and approving of standard operating procedures.


• Perform spot-checks in the QC Lab. to ensure compliance with written regulations, policies, procedures, and global procedures.


• Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.


• Strive to reduce non-conformances in supported areas by proactively driving compliance.


• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.


• Critically support investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.


• Recognize patterns and trends in reported data and communicate to management.


• Provide guidance in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities.


• Routinely recognize and resolve quality issues. Seeks management guidance on complex issues. Develops procedures.


• Be able to interpret complex results and situations with degree of independence and articulate recommendations for solutions. Identifies risk and develops contingency plans.


• Drive continuous improvement.

Wie ben jij?

• A minimum of a Master Degree in Engineering, Science or equivalent technical area is required.


• Experience in Quality Assurance in a GMP environment is a plus


• Experience in microbiological testing methods is preferred


• Experience in biotechnology methods like flow cytometry, qPCR, ELISA is preferred


• Experience in cell culture is preferred

Wat bieden wij jou?

Working with Johnson & Johnson isn’t just any job. Every day, we’re creating life-changing treatments for infectious diseases, improving global health equity, and developing medtech innovations, pharmaceuticals, and consumer health products that enhance quality of life for people worldwide. From 3D printing and robotics that are transforming surgical procedures to drones delivering vaccines to remote regions, our work is bigger than all of us.

And our workdays are as unique as we are.

But no matter what you’re working on or how you spend your time, your work is important.

Extralegale voordelen

• Maaltijdcheques


• Woon-werk verkeer


• Hospitalisatieverzekering


• Groepsverzekering


• Pensioensparen


• Vakantiegeld


• 13de maand

Werkomstandigheden

• Flexibele werkuren


• Glijdende werkuren


• Reizen is een mogelijkheid

Taal

• Engels


• Engels


• Nederlands


• Nederlands

Competenties

• Analytisch


• Besluitvaardig


• Communicatief


• Initiatiefnemer


• Stressbestendig