Quality Assurance Specialist – Biotech Manufacturing

Donaldson is committed to solving the worlds most complex filtration challenges. Together we make cool things. As an established technology and innovation leader we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn effect change and make meaningful contributions at work and in communities.

Join a growing international biotech organization at the heart of innovation in bioreactors and control systems. As a Quality Assurance Specialist youll contribute to product integrity continuous improvement and operational excellence.

Whats in it for you

• A unique opportunity to work across multiple areas of QA: production warehouse validation and supplier/customer interfacebroader than most QA roles.
• A dynamic and supportive team culture where your initiative input and hands-on mindset can directly shape daily operations and product quality.
• Long-term contract with a competitive salary health insurance pension plan meal vouchers and growth opportunities in a fast-evolving organization.

Role Responsibilities

• Support the release of high-quality products (single-use bioreactors manifolds and controllers) by reviewing batch records and ensuring quality standards are met.
• Oversee cleanroom operations incoming inspections and quality control activities ensuring compliance with internal procedures and regulatory expectations.
• Coordinate and follow up on quality events (deviations document reviews change requests CAPA) providing guidance across production logistics and maintenance.
• Contribute to project workstreams by supporting validation activities (DQ FMEA IOQ PQ) and approving specifications and drawings.
• Support internal audits and quality system documentation updates while helping teams understand and apply quality processes.
• Collaborate with cross-functional stakeholders to drive continuous improvements and deliver practical solutions in a dynamic production environment.

Minimum Qualifications

• Fluency in both French and English (written and spoken).
• Prior experience with single-use technologies or qualification of hardware/software equipment in a regulated environment.
• Strong understanding of quality systems (non-conformities GMP practices document control).
• Ability to work independently prioritize tasks and adapt in a fast-paced setting.
• Competency in Microsoft Office tools especially Excel Word and PowerPoint.

Preferred Qualifications

• Masters degree in a scientific or engineering discipline.
• 5 years of experience in a quality production or validation role in a GxP-regulated environment (e.g. biotech pharma or medical devices).

Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.

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Our policy is to provide equal employment opportunities to all qualified persons without regard to race gender color disability national origin age religion union affiliation sexual orientation veteran status citizenship gender identity and/or expression or other status protected by law.