QA/RA Officer (by Scinus Cell Expansion in Bilthoven)
Do you have experience with Quality and Regulatory Affairs (QA / RA) in the field of development and certification of medical products and / or lab equipment and do you want to work in a dynamic environment with a wide variety of activities? Then we are looking for you!
QA / RA Officer at SCINUS Cell Expansion is a challenging position with very diverse activities. You work closely with all disciplines within SCINUS, but you also have contact with external parties. We are looking for someone with at least 2-3 years of experience as a QA / RA professional in the field medical products and / or lab equipment.
As a QA / RA officer you are part of our multidisciplinary team. Within this team you are the point of contact in the QA / RA field of medical products and / or lab equipment. Your activities will relate to the development and certification of medical products and / or lab equipment.
As a QA / RA Officer, your challenge is to ensure product safety and proper practices in line with our quality system (ISO 9001), and in accordance with applicable guidelines (e.g. CFR 820 FDA Quality System Regulations, CGMP, advanced therapeutically medical product manufacturing). Within the development projects you are responsible for product safety, you determine which laws and regulations apply and you coordinate these matters with the customer. For certification, you have to arrange the technical file.
You have the following competences:
- a medical / technical background (minimum Msc work and thinking level);
- at least 2-3 years of relevant experience as a QA / RA professional in the field of development and certification of medical products and / or lab equipment;
- analytical skills and you understand the language of the engineers and ATMP professionals;
- you are a team player, make contact easily, communicate and switch well at various levels, both towards the project team and the customer;
- you are accurate, convincing and pragmatic;
At SCINUS you end up in a growing and innovative company. Scinus Cell Expansion Netherlands BV, based in Bilthoven, develops and distributes bioreactor technology for stem cell therapy. Our mission is to make cell therapies accessible to a global patient population. SCINUS technology enables 3D culture on a clinical scale in a controlled environment and provides a cost-effective alternative to 2D cell growth in tissue culture bottles. The system includes a single-use bioreactor bag that can be used to culture stem cells to clinically relevant numbers of cells. In addition, SCINUS can support customers in optimizing cell culture processes. We welcome your own initiative and you will have plenty of room for it. This includes a competitive salary and flexible working conditions.
Thanks to enthusiastic and committed colleagues, the lines in our organization are short and the working atmosphere is open and informal. Nice contacts are created, both on the work floor and outside.
How to react
Have we aroused your interest for this position? Then we would like to receive your CV. Applying for the position of QA / RA officer is done by sending your letter with motivation and concise CV to firstname.lastname@example.org, for the attention of Marleen Blanckenborg.
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