Qc Technician

Il y a 2 mois

MontSaintGuibert, Belgique Cellistic Temps plein

The mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to getting better, more efficient treatments to patients faster. To achieve this mission, we are building a world-leading research facility to overcome the complexity and challenges of iPSC lineage specification. We will know we have succeeded when we can reliably and rapidly generate cell products that consistently produce positive outcomes in patients.

**Responsibilities**:

- Perform a wide variety of QC release tests, characterization tests and sampling enabling release of clinical and development batches (including start material, raw materials and consumables, in process samples, DS, DP) according to internal SOPs and in line with GMP
- Record, report and review data obtained for compliance to specifications (including double checks) and report abnormalities
- Execute daily operational QC activities, incl. but not limited to cleaning program; calibration, monitoring and maintenance of lab equipment, sample reception, registration and storage, environmental monitoring and recording, ordering of material and reagents in accordance with ERP and budget
- Initiate and follow-up on QC/QMS-related GMP documentation, including CCR, RD/events, OOS and CAPA, under supervision
- Support to writing and revising of SOPs and associated documents (incl. batch records, work files, checklists, sampling procedures) related to routine QC testing of GMP batches, in line with GMP.
- Execute investigational (incl. batch failures), development, qualification and validation studies, led by validation unit
- Check appropriate reception, registration and storage of QC samples
- Contact CROs for outsourced testing under supervision (organization and preparation of shipments of samples, request and inspection of analysis, recording of results)
- Work in a constructive and flexible way in a team

**Qualification & Experience**:

- Perform a wide variety of QC release tests, characterization tests and sampling enabling release of clinical and development batches (including start material, raw materials and consumables, in process samples, DS, DP) according to internal SOPs and in line with GMP
- Record, report and review data obtained for compliance to specifications (including double checks) and report abnormalities
- Execute daily operational QC activities, incl. but not limited to cleaning program; calibration, monitoring and maintenance of lab equipment, sample reception, registration and storage, environmental monitoring and recording, ordering of material and reagents in accordance with ERP and budget
- Initiate and follow-up on QC/QMS-related GMP documentation, including CCR, RD/events, OOS and CAPA, under supervision
- Support to writing and revising of SOPs and associated documents (incl. batch records, work files, checklists, sampling procedures) related to routine QC testing of GMP batches, in line with GMP.
- Execute investigational (incl. batch failures), development, qualification and validation studies, led by validation unit
- Check appropriate reception, registration and storage of QC samples
- Contact CROs for outsourced testing under supervision (organization and preparation of shipments of samples, request and inspection of analysis, recording of results)
- Work in a constructive and flexible way in a team

**Skills & Competencies**:

- Focus on quality, compliance and detail
- Be organized, autonomous and flexible
- Excellent interaction & communication skills, strong team spirit
- Languages: good level of English and French (oral and written)
- Can do attitude
- Strong Analytical skills
- Work precisely per procedures, rules and regulations and planning

**Job Location**:Mont Saint Guibert, Belgium

**Position Type**: Full-Time

**Start Date**:Immediately

We offer you a challenging position in a dynamic biotech company with room for personal growth and development. We provide a competitive salary package based on your education and experience.

**Interested?**:

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