Are you an experienced Quality Assurance (QA) Officer? Do you have knowledge of Good Clinical Laboratory Practice (GCLP) quality standards? Are you ready for a new challenging project in a growing high-end laboratory?
Join our team and become our QA Officer GCLP!
Who are we?GenomeScan is a service provider of innovative DNA and RNA analyses. We offer fast, affordable, and high-quality patient diagnostics, which are crucial for identifying disease causes and supporting individual treatment plans. We also undertake projects for research groups and clients in the pharmaceutical and biotech industries.
We take on a diverse range of challenging projects using advanced Next Generation Sequencing (NGS) techniques, including Whole Genome, Exome, and Gene-panel Sequencing, RNA- and Methyl sequencing, and various bioinformatics pipelines. Our laboratory is equipped with the latest Illumina, PacBio, Ion Torrent, and Nanopore sequencers, as well as robotic systems for automated sample processing. GenomeScan complies with international quality standards and holds ISO/IEC 17025 and ISO 15189 accreditations.
In addition to our current ISO accreditations, we are implementing GCLP guidelines in our laboratory to improve and expand our services for clinical trials.
We are looking for a QA Officer with experience in GCLP guidelines.
What will you do?You will:
- Be responsible for maintaining a Quality Management System that ensures compliance with GCLP quality standards and applicable regulations.
- Execute tasks to ensure consistent quality and compliance (Deviations, Change Control, CAPA, Complaints, Equipment Control, Document Control).
- Coordinate and support internal and external audits, including those involving suppliers, certified bodies, and customers.
- Oversee risk management activities to identify, assess, and address potential quality and compliance risks.
- Support the integration of GCLP documentation in the existing ISO-based Quality Management System.
- Bachelor's degree in Life Sciences or Molecular Biology or equivalent educational level.
- A minimum of three years of experience in quality management within Life Sciences.
- Knowledge of GCLP guidelines; understanding of ISO/IEC 17025 and ISO 15189 is an advantage.
- Experience with the use of digital Quality Management Systems (such as Zenya).
- Experience with performing audits is a plus.
- Proficiency in English, both verbally and in writing; Dutch is a plus.
- Willing and able to work on-site (Leiden) when the work requires.
- Meaningful work with a challenging role at a company that believes Next Generation Sequencing applications can contribute to improving healthcare.
- A competitive salary, based on your knowledge and experience.
- An end-of-year bonus/ 13th month payment (8.3% of gross annual salary).
- A holiday allowance (8% of gross annual salary).
- A total of 200 holiday hours (based on full-time employment for a full year) with the possibility of buying/selling leave hours.
- A collective pension scheme, with 50% of the contribution paid by GenomeScan (Partner pension is included).
- A travel allowance or NS Business Card for your commute to and from Leiden.
- A company laptop and telephone.
- A caring, inclusive and informal working environment in which you will be able to demonstrate your competences and knowledge.
Do you see yourself in this role? Great! We look forward to receiving your application!
Not sure yet? Would you like to know more first? Contact Yvonne Klein at hr@genomescan.nl.
#J-18808-LjbffrSalarisomschrijving€45000.00 - €60000.00 monthly