QC CAR-T Investigation Coordinator

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

About Innovative Medicine  

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow. 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. 

Learn more at https://www.jnj.com/innovative-medicine 

CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system.

The patient's T-cells are genetically modified to eliminate the cancer cells.

This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.

We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we have developed a new production site.

We are looking for strong talents who are eager to participate in this innovative and hopeful venture.

We are searching for the best talent for a QC CAR-T Investigation Coordinator, to be in Beerse.

Your tasks and responsibilities with the QC team are the following:



* Support daily operations within QC, work closely together with supervisors, analysts, production, warehouse and QA.


* Leading investigations and writing a final investigation report based on a thorough


* root cause analysis.  You define, implement corrective actions and monitor their effectiveness, ensuring timely execution and closure.  If it concerns a cross-departmental QC investigation, you will manage a multi-disciplinary team.  You are the QC representative in cross-departmental investigations.


* Supporting and implementing improvement projects for the team in the areas of safety, quality, efficiency and customer satisfaction.


* Develop training/awareness sessions within QC.

 

 Qualifications


* A minimum of a Master’s degree in a biochemistry and biotechnology related degree


* Knowledge of cGMP regulations and FDA/EU guidance is required.


* High organizational skills and independent and flexible way of working are required.   


* Excellent written and oral communication skills are required  
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