QC Analyst
QC Analyst
09/09/24
Location
Ghent, Belgium
Vacancy
Ready to make a real impact on patients' lives and embark on an exciting new adventure? Join our Quality Operations Team in Ghent, where your passion for quality will drive you to exceed your own expectations. We're not just about striving for excellence; we believe in having a blast while doing it. If you're eager to grow, innovate, and have fun with a fantastic team, then you're in the right place with us!
What can you expect?
As a QC analyst, you will play a critical role in ensuring the highest quality of life-saving cell therapy products. Here's what you'll do:
Advanced QC Testing: You will perform QC testing for CAR-T products in IPC laboratories and ensure compliance with all procedures, standards and GMP regulations.
Environmental monitoring: You verify clean room classification by taking samples of (non-) viable particles and microorganisms.
Collaboration: You will work closely with the Quality and Operations departments to bring analytical testing from the test bench to production.
Documentation and data management: You will review and approve QC data, maintain process integrity through accurate documentation, and manage test results in our eLIMS software.
Process Optimization: You will create and review QC documents, SOPs and work instructions and also contribute to process optimizations.
Who are we looking for?
Education:
You have a bachelor's degree in lab technologies or other related field, or equivalent experience.
Experience:
Practical experience in an aseptic production facility within QC or QA is a plus but certainly not a must. We offer you the necessary training to get you started in your new role.
Languages:
You have strong written and oral communication skills in both Dutch and technical English.
Strengths:
You are well organized, you can multitask and you are a real team player
Expertise:
You have knowledge of cGMP regulations and FDA/EU guidelines.
Practical experience with aseptic processing in ISO 5 clean rooms, familiarity with CAR-T QC testing methods and Good Tissue Practices is a plus.
What do we offer you?
A meaningful job with an excellent work-life balance. You will work 4 days. After that you will enjoy 4 days off.
A supportive and innovative work environment. We value and encourage learning and personal development.
The opportunity to work with people from all over the world.
A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.
Many fun and informal events.
About Legend Biotech
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing and commercializing innovative and life-saving cell therapies, including treatments for intractable diseases such as cancer.
Since our founding in 2014 in Somerset, New Jersey, we have grown into a company with more than 2,000 employees in six manufacturing facilities worldwide.
In Ghent, we are focusing on the production of our advanced CAR-T therapy for the treatment of multiple myeloma, in collaboration with Johnson & Johnson.