Qs Document Management Associate Car-t

il y a 14 heures

Gent, Belgique Johnson & Johnson Temps plein

**Job Function**:
Non-Standard
**Job Sub Function**:
Workday Associate B
**Job Category**:
Non-Standard
**All Job Posting Locations**:
Gent, East Flanders, Belgium

**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.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

**We are searching for the best talent for a Quality Systems Document Management Associate CAR-T.**The position will be based in Ghent

The QS Document Management Associate CAR-T is responsible for quality systems document management support of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Administrative Support within the Document & Training Management team.

**You will be responsible for**:

- You will be responsible for providing administrative support in both document management and training management, with a focus on compliant and efficient processes.
- Management of procedures and related documents in Truvault
- Management of training setup in Summit
- Fulfill the site key user responsibilities: represent CAR-T Belgium in global forums and team meetings, mentor site users for the document management process, and control access to the system
- Maintain a clear archive in line with Worldwide Record Information Management policies
- Perform tasks in accordance with Janssen/Johnson & Johnson policies, quality systems, and cGMP requirements
- Attend regularly scheduled team meetings and training
- May participate in process improvement and training
- May be assigned as a coach or mentor to less experienced colleagues

**Experience and Skills**

- A bachelor degree is required
- Experience with document management systems (Truvault) and training platforms (Summit), but this is not considered a must
- Familiarity with quality and compliance processes (cGMP)
- Proactive, initiative-taking, and capable of implementing improvements
- Proficiency in English and Dutch (verbal and written), as well as good personal communication skills are required
- You have a quality mindset, keeping customer requirements in mind
- You are flexible to support shifting priorities
- You are a team player that gets energized by collaborating with colleagues and providing support to the site users

**Here’s what you can expect**:

- **Application review**:We’ll carefully review your CV to see how your skills and experience align with the role.
- **Getting to know you**:If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
- **Staying informed**:We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.

**Required Skills**:
**Preferred Skills**:

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