Full time position
Vacancy for a Quality Associate
“Will you support us making cancer a chronic disease?”
The role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role.
The Quality Associate will be part a team of young, driven QA-professionals in a GMP environment on activities related to cell therapy and regenerative medicines. You will support your team in establishing a quality system of allogeneic cell products in accordance to GMP and applicable international guidelines.
The Quality Associate supports the department and site in publishing of metrics and reports. The Quality Associate interacts directly with other departments on Changes, CAPPA, Deviation management and documentation. As Quality Associate you must identify, defend, and resolve quality issues with appropriate supporting documentation. A Quality Associate must be able to weigh the risk of the event and look for the efficient yet compliant solution.
In this role you must likewise perform a variety of routine work within established procedures, and receive general instructions on new assignments.
- Consult with QA manager on decisions to ensure alignment and agreement.
- Review of the Batch records, related deviations, CAPAs and CRF as well as OOS and EMP investigations
- Review Glycostem SOP’s, forms, and test methods within Document Management System (DMS)
- Responsibility to ensure changes are justified; procedures are followed and contain appropriate associated reference.
- Review and approve non DMS documents (executed work orders, Engineering Preventative Maintenance documents, Environmental Action Reports)
- Perform other duties as assigned.
Education, skills and experience
The job as Quality Associate will be held by a person with:
- BSc /MSc. in Science, Biotechnology or related discipline with focus on cell biology and/ or human cell culturing techniques (stem cells, primary cells and/or tissue culture)
- 3 years’ experience in a GMP-environment
- 1-2 years’ experience in Quality Assurance
- Good understanding of GMP’s, regulations, and compliance in a GMP manufacturing setting
- Good proficiency in English
- Good knowledge of standard MS-Office products
- Attention to detail, works effectively individually and with teams.
Duration of employment:
After a successful trial period a permanent contract is extended.
Do you have what it takes?
Please convince us by sending your motivation and CV in English to Liana van Genuchten (HR@Glycostem.com). Selected candidates will be invited for a face-to-face interview with the line management.
Want to know more?
E-mail our HR department at HR@Glycostem.com for more information about Glycostem and the selection process.
Recruiters should not contact us.
Please be aware that your application means that the information you provide will be shared by and with HR and the employees who are involved with the procedure. In case the procedure with you ends, your application and provided information will be deleted within four weeks after the moment you have been informed. Your name and date of application will be registered in our database for statistical use and status only. By applying you agree with and have taken notice of these conditions.