Qc Technician

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 fulfill 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 Technician - QC Services.

**The Role**

The QC Technician - Services main role is to perform all administrative and laboratory activities inside the Microbiology & QC Services platforms.

The responsibilities can be adapted and may cover the following topics (Microbiology activities, EMS, Equipment, Outsourcing, Training, RM sampling, Lab Management, Cleaning, ) to support all QC platforms with a GMP quality grade and in an efficient way.

The QC Technician - Services reports to the QC Supervisor and/or QC Manager.

In order to fulfill his / her role, he / she:

- Performs his/her duties and document his/her work according to Catalent’s current procedures and GMP rules.
- Performs QC tests in due time according to the planning and in compliance with effective instructions / procedures and all laboratory / safety procedures.
- Performs routine Microbiological testing (Environmental Monitoring samples, Growth Promotion test, sterility test,).
- Participate to the routine general testing (visual inspection,).
- Performs on due time routine and planned maintenance, calibration, qualification of equipment in the QC Department.
- Performs the samples shipment (outsourcing) for the QC department.
- Check daily / weekly EMS.
- Interprets analytical results and warns immediately the QC Expert / Supervisor or Manager in case of unusual event / result / OOS.
- Double checks filled forms or data generated for testing which he / she is trained.
- Fills Certificates of Analysis and ensures that a sample will only be released if its specifications are met.
- Initiates or reviews DEV, OOS, CHC linked to the Microbiology & QC Services platforms and leads necessary investigation. Implement CAPA.
- Participates in troubleshooting of experiment and equipment issues.
- Performs the management of routine QC Reagents stock level.
- Order the adequate material, reagents, consumables and ensures its availability in due time in QC laboratories.
- Request the picking of the incoming material reference samples and assure their storage in the appropriate conditions.
- Performs the maintenance of the laboratory (bench and floor cleaning, waste evacuation, general aspect )
- Dispatch controlled copies in the laboratory and remove expired copies.
- Drafts QC documents (INS, PRO, FORM, GSPE).
- Follows the needed training on due time.
- Maintains open, effective, constructive and positive communication with all other QC members and with other departments.
- Warns immediately the QC Expert /Supervisor or Manager in case of problem or failure or security issue.
- Participates actively to the weekly QC meeting.
- Works to keep department KPI in green.
- Takes part to internal and/or external audits, if necessary
- Bachelor degree or equivalent by experience
- Experience in cGMP environment and/or quality control is a plus.
- Organization skills, multitasking, flexibility and autonomous.
- Results oriented; problem solving.
- Quality minded, rigorous and pro-active.
- Fluent in French and English (at least A2 level).
- Computer skills: Microsoft Office, Compliance Wire, TrackWise are a plus.

**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.
**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.
**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 qu