Quality Assurance/ Quality Control Officer
Sittard-Geleen, 7 November 2017
Within the Biomedical program we are building a (Bio)medical Accelerator Matrix: to accelerate the process from patent to patient. Many potential biomedical concepts don’t reach their potential, because the road from idea to market is a long, arduous one. The Matrix is created to fill this gap. It creates the conditions for our clients to learn whilst working in a tailor made plug-and-play setting with infrastructural, technical and service elements. At the heart of the matrix is the quality management system that defines and sets the standard for everything we do being it in research projects or with our start-ups.
We believe that by sharing knowledge, expertise and facilities we can fill the knowledge-gap and by doing so limit the costs. Currently within our facilities, we work with 4 start-up companies and six multi-partner development projects in the medical device and cell therapy field to translate their concept into first-in patient proof of principle.
We are looking for a Quality Assurance / Quality Control Officer to complete our team
The Quality Assurance / Quality Control (QA/QC) Officer is responsible for planning and execution of the necessary quality control activities and supports projects and daily quality assurance activities.
Position within InSciTe
The QA/QC Officer is a member of the InSciTe team and works side-by-side with the QA Manager, Biomedical Facility Manager and Biomedical Technician.
Responsibilities and key tasks
- Supporting the multi-disciplinary project teams in regulatory processes;
- Hands-on support in project quality processes, (e.g. FMEA, Document (Control) Plan);
- Help set up and develop quality control methods;
- Performs timely and accurate routine quality control analysis using established test methods;
- Monitor compliance with all applicable ISO/GMP and safety standards;
- Write quality control reports;
- Support internal/external audits and quality training.
Required knowledge and experience
- Relevant degree/level in biomedical related area or at least 1-3 years of expertise in QA support / QC;
- Preferably regulatory or clinical experience;
- Experience in and knowledge of quality systems and ISO certification (ISO 13485 and relevant standards) in the biomedical/regenerative medicine field;
- Knowledge of GMP;
- Experience in writing QMS procedures;
- Experience in QC;
- Excellent command of English, spoken and written;
- Basic mathematical/statistical skills.
- Accurate, structured and precise
- Independent and selforganized
- Perform under pressure
- Flexible: adapts easily to new circumstances
- Able to manage multiple priorities with good follow through
- Positively contributing to a good working atmosphere within the team, team player
- Good communication skills
A challenging job with lots of training opportunities and a variety of responsibilities within QA/QC in an open innovation setting. You will be part of a small, but highly motivated team that is keen to help, share and learn. This is in principle a full time position (40 hours per week). Any part-time interpretation based on at least 4 days a week is negotiable.
For more information contact Surge for Science, Annefleur Jacobs
Phonenumber:+31 43 321 7171