A Junior Quality Assurance position is immediately available in the TIGET Clinical Lab (TCL) coordinated by dr. Matias Soncini at the San Raffaele Telethon Institute for Gene Therapy (SR-Tiget), Milan, Italy.

The TCL is one of the Development and Clinical Research units present at TIGET. In particular, it is a Clinical Research laboratory that performs analysis on samples from patients that underwent experimental Gene Therapy. TCL is an AIFA autocertified Phase I laboratory where the biological effects of Gene Therapy are studied following approved Clinical Protocols and in compliance with Good Clinical Laboratory Practice (GCLP) and ISO 9001.

The position.

We are looking for a motivated junior Quality Assurance officer to join us for a position in TCL, working in collaboration  with other TIGET QAs

Main tasks

• Management and maintenance up to date Quality Documentation
• Distribution of Quality Documentation to the Staff
• Maintenance of staff training documentation.
• Verify/Writing IOS, Modules or template as for his/her competences
• Support for AUDIT/inspection

Secondary tasks (after seniority)

• Conducting the Quality Assurance activities: internal audits to ensure compliance with appropriate Standard Operating Procedures and regulations
• Provide support to staff in laboratory activities in terms of GCP, GCLP and Determina AIFA compliance
• CAPA management and collaboration with Lab Coordinator, Laboratory Study Manager, and Scientific Project Leader to resolve NC or any issue coming out from AUDITs and/or inspections.
• Organisation of Quality assurance task training.
• Support on definition, collection, and analysis of Unit indicators
• Participate to Analytical and Feasibility Plans

Qualifications and Skills:

• Scientific Bachelor or Master’s Degree with previous wet lab experience
• Knowledge of Quality Systems gained by experience or training
• Experiences in ISO (900115189), GLP, GCP or IVDR are a plus
• Effective communication
• Analytical and problemsolving skills
• Friendly, collaborative, proactive mindset
• Good oral and written English

We offer

• Salary depending on qualifications and experience.
• A dynamic environment and the chance to give important contribution to clinical translation of innovative ATMP

Applications, including a CV, should be sent by e-mail to soncini.matias@hsr.it. Evaluation of applications/interviews will begin immediately and continue until the position is filled.

For more information click here