Our client is an innovative organisation within the pharmaceutical and biotechnology sector, focusing on advanced CAR-T immunotherapies for the treatment of cancer. These therapies are manufactured on site in hospitals, simplifying logistics and ensuring faster patient treatment and better outcomes. As part of their growth, they are seeking a motivated Quality Assurance Specialist for the Quality Control (QC) department. You will work in a dynamic and fast-growing environment where quality assurance and compliance are key.
Job Description:
In the Quality Assurance role for the QC department, you will be responsible for supporting the quality control processes within a laboratory environment. You will work closely with the QC team to ensure that all materials and products meet required quality standards and regulations. You will manage and update work instructions and SOP's, monitor materials intake and participate in the product release process. This position is critical to maintaining high quality standards and ensuring compliance in the production of CAR-T cells.
Responsibilities:
- Support quality assurance activities within the laboratory and QC department, with emphasis on compliance with applicable pharmaceutical and biotechnology guidelines.
- Manage and update laboratory work instructions and SOP's to ensure consistency, precision and regulatory compliance.
- Check and verify incoming materials and products, ensure proper documentation according to quality standards.
- Assist in quality control and laboratory testing to ensure all materials and products meet established specifications.
- Participate in the release process by ensuring complete and accurate documentation of QC checks and test results.
- Actively collaborate with the QC team to identify and resolve quality issues within the laboratory in a timely manner.
- Contribute to the improvement of quality processes within the laboratory environment, based on data analysis and best practices.
- Support the implementation and compliance of quality management systems (QMS) within the QC department, focusing on compliance with EU and US regulations.
Profile:
- Graduate degree in biotechnology, pharmacy, or a related field, with experience in quality assurance or quality control within a laboratory.
- In-depth knowledge of quality standards, pharmaceutical regulations, and GMP (Good Manufacturing Practice) within the biotechnology industry.
- Experience working in laboratory environments, with a focus on product quality and process control.
- Strong communication skills in English, both oral and written.
- Attention to detail and the ability to work accurately in a dynamic environment.
- Ability to work independently, but also function well within a team of professionals.
Working conditions:
- Minimum 60% FTE, with flexible working hours and opportunities to work from home.
- Salary between €5000 and €7000 per month on a secondment basis, depending on experience.
- A contract of at least 6 months, with the possibility of extension depending on project needs.
- The possibility to work one or two days a week at the Leiden office in a stimulating, international working environment.
- Extensive opportunities for professional development and growth within the biotechnology and pharmaceutical sector.
- Vacaturenummer: 25290
- if you do not have a valid working permit in the Netherlands you will not be considered for this position
