Department Quality Assurance

HUB Organoids is looking for an experienced QA Officer who wants to use his/her expertise to support our mission to the acceleration of drug discovery pipeline for our customers, applying our state-of-the art organoid ("a patient in the lab") technology. You contribute to the success of HUB by ensuring the quality and compliance of our Quality Management Process and by safeguarding the high quality standards for HUB Organoids products.

Scope of the Position

Join our QA team in a fast-growing, dynamic and world leading biotech company. As a QA officer, you maintain our quality management system (QMS) by guiding document, change, and nonconformity (NC) management. In addition you will support the further implementation of our QMS towards a ISO9001 certification by writing QA-related documents and creating awareness on the QMS within the company. You will be working closely with the QA manager.

You are flexible and adaptable on the one hand but on the other confident in assuring compliance to the QMS. Next to this, you have worked within a quality role and gained experience in maintaining a QMS, including compliance to applicable laws and regulations, like ISO, GMP or IVD. Your experience includes writing and reviewing standard operating procedures. With 2-3 years of relevant experience, you know how to communicate QA topics in an effective, friendly, and respectful way to different organizational levels.

You thrive in an environment in which part of the quality related processes still needs to be defined and love working together with different stakeholders such as the research team, business developers and project managers.

What will you do?

• Support the maintenance and development of the QMS by reviewing, writing and monitoring different document types such as Laboratory manuals, standard operating procedures (SOP's).
• Guide the drafting and implementation of Changes, Nonconformities and CAPAs.
• Ensuring compliance to requirements defined in the QMS, by monitoring compliance to valid processes and procedures, for example by providing training on QA-related topics to individuals or employee groups.
• Organizing and conducting internal audits as co- or lead-auditor.
• Operate as Document Controller and System Admin support for our eQMS.
• Support supplier evaluation and qualification process.
• Masters degree in the field of Life sciences or another related technical area.
• 2-3 years of relevant work experience in quality in laboratory environment or biotech company , preferably in a commercial, ISO-certified (or alike) environment
• Experience with writing and reviewing standard operating procedures
• You are eager to develop into an all-round QA officer.
• You are able to work independently and manage your time efficiently.
• You are flexible and adaptable and able to handle changing priorities and tasks.
• You are proficient in English (written and verbal).

What will you bring?

What we offer and who we are

• Friendly and international environment make you feel home.
• Competitive salary with attractive benefits like 30,5 leave days plus national holidays.
• Pension Plan with 2/3 contribution paid by HUB.
• Flexible work from home policy.
• HUB, located in Utrecht (The Netherlands), is an open and energetic organization, where a multi-cultural team is passionate to refine organoid development and foster organoid adoption globally. Our technology brings a ‘patient in the lab’ by utilizing patient-derived organoids to develop and test drug and other treatment. Experience a stimulating work environment, opportunities for professional growth, and the chance to make a lasting impact on patient-centric research. We’re a fast-growing, world leading biotech company in organoid technology and if you are passionate about pushing the boundaries of scientific innovation, apply today!