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1 maand geleden
We are a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium. Our mission is to change lives by discovering and developing life-improving medicines.
We're a team of innovators and perseverant idealists who pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators who can help us build our QA model for our expanding organization.
Job Title: Quality Assurance Coordinator for Cell and Gene TherapyEstimated Salary: €60,000 - €80,000 per year, depending on experience
About the Role:
We are seeking a highly motivated Quality Assurance Coordinator to support our QA team in setting up, promoting and maintaining the QA model in our dynamic business environment.
As a Quality Assurance Coordinator, you will report to the QA Manufacturing Operations Lead, in the IMP QA Oncology team based in our Central EU site in Leiden, NL.
Responsibilities:
- Manage QM attributes for PoC and Central Site activities: Deviations, CAPAs, Change Controls and Complaints
- QA batch record review
- Support materials release and support batch release process
- Support equipment management at our PoC locations
- Provide QA support to the materials kitting process
Requirements:
To be successful in this role, you should have a strong background in Quality Assurance and excellent communication skills. You should also be able to work independently and as part of a team, with a high level of attention to detail and organizational skills.
