
Qc Specialist Flow Cytometry
il y a 3 semaines
Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients.
To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated **QC Specialist Flow Cytometry**, you will be reporting to the Flow Cytometry QC Supervisor
**The Role**
The Flow Cytometry QC Specialist main role is to perform all administrative and laboratory activities in order to evaluate the quality of the cell therapy products with a GMP quality grade and in an efficient way.
- Perform QC tests in due time according to the team planning, and in compliance with effective instructions /procedures and all laboratory/safety procedures
- Ensure the availability of reagents, consumables in due time and assist the QC support in the management of QC Reagents stock level
- Perform his/her duties and document his/her work according to Catalent’s current procedures and GMP rules
- Interpret analytical results and warn immediately the QC PL / Supervisor / Manager in case of unusual event/result/OOS
- Participate in troubleshooting of experiment and equipment issues
- Initiate or review deviations, OOS, CHC linked to the Flow Cytometry platform and lead necessary investigation. Implement CAPA
- Double check filled forms or data generated by QC Experts / Specialists / Technicians, for testing which he / she is trained
- Fill certificates of analysis and ensure that a product will only be released if its specifications are met
- Fill datawarehouses; control charts and all other needed follow-up files
- Participate to the drafting / review of instructions and forms in collaboration with MSAT / P&AD department
- Assist the QC support in daily maintenance of the laboratory (bench and floor cleaning, waste evacuation, general aspect, etc)
- Warn immediately the QC Supervisor/ Manager in case of problem or failure or security issue
- Participate actively to the weekly QC team meeting
- Maintain effective, constructive and positive communication with all QC team members and other departments
- Take part to audits when necessary
- Bachelor degree or higher in biology, biomedical sciences, biochemistry, clinical chemistry
- Experience in Flow Cytometry methods is requested
- Experience in cGMP environment and/or quality control is a must
- Teamwork
- Results oriented; problem solving
- Quality minded, rigorous and pro-active
- Able to work autonomously
- High sense of engagement and ownership
- Computer skills: Microsoft office, Compliance Wire, Ms Teams, TrackWise are a plus
**Position Benefits**
- Full-time position (40h/week)
- An indeterminate contract
- The opportunity to take part in a growing dynamic biotech company
- A human-sized working environment with a convivial atmosphere
- Health & Group Insurance, meal-vouchers, eco-vouchers
**Catalent’s standard leadership competencies that are used to interview and for Performance & Development**
- Delivers Results
- Leads with Integrity and Respect
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
**Catalent offre des opportunités enrichissantes pour faire avancer votre carrière** Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu'un qui compte sur nous. Rejoignez-nous pour faire la différence.
Catalent s'engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d'intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.
Initiative personnelle. Rythme dynamique. Un travail significatif.
Visitez Catalent Careers pour explorer les opportunités de carrière.
Catalent est un employeur garantissant l'égalité des chances et ne fait aucune discrimination sur la base
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