QA Specialist

As a Quality Assurance Specialist, you play a pivotal role in ensuring compliance, maintaining quality standards, and driving operational excellence across our organization. You will work closely with laboratory, manufacturing, technical, and quality teams to ensure activities are performed in accordance with GxP, ISO, and customer requirements.

More than a quality guardian, you are a trusted advisor, coach, and change agent who helps strengthen our quality culture and supports the successful delivery of high-quality services to our clients.

• Oegstgeest, Netherlands
• Full-time

Company Description

Eurofins BioPharma Product Testing Leiden B.V., part of the globally operating Eurofins Scientific network, is a leading GMP-certified contract laboratory serving the (bio)pharmaceutical industry. Based at the Leiden Bio Science Park, we provide a comprehensive range of microbiological, viral, chemical, and physical quality control testing for pharmaceutical raw materials, intermediates, and finished products. In addition to our standard test packages, we develop and validate productspecific methods in close collaboration with our clients, and we also offer small-scale manufacturing services.

We have a professional team consisting of a mix of young and experienced people with different backgrounds and experiences. Together we strengthen global healthcare and help advance the pharmaceutical product quality and patient safety worldwide.

Job Description

Responsibilities

• Ensure compliance with GxP, ISO, and internal quality standards.
• Act as a QA Subject Matter Expert (SME) for Chemistry Testing, Biosafety Testing, and/or Manufacturing Operations.
• Review, assess, approve, and close deviations, change controls, customer complaints, OOS investigations, and CAPAs in accordance with GMP requirements.
• Ensure high standards of documentation and compliance with data integrity principles.
• Support quality assurance activities and continuous improvement initiatives across the organization.
• Contribute to risk management through risk assessments, troubleshooting, and root cause investigations.
• Train, coach, and mentor colleagues while fostering a strong quality culture.
• Support digitalization and automation initiatives within Quality Assurance.
• Collaborate across departments to ensure compliance, operational efficiency, and customer satisfaction.

Tasks

• Participate in daily team meetings and contribute to operational planning and execution.
• Perform routine QA activities in accordance with SOPs and quality standards.
• Review and approve analytical protocols, equipment documentation, reports, SOPs, and Certificates of Analysis (where applicable).
• Ensure data integrity, traceability, and accuracy of records and documentation.
• Support the implementation and harmonization of QA procedures across the organization.
• Assist in the planning, preparation, hosting, and follow-up of internal, customer, and regulatory audits and inspections.
• Identify, assess, and escalate quality risks, deviations, and non-conformities.
• Support investigations, troubleshooting activities, and root cause analyses.
• Ensure customer complaints are investigated and addressed effectively.
• Collaborate with SMEs in the field of data governance.
• Act as deputy to the QA Manager for designated disciplines and responsibilities when required.
• Identify, initiate, and lead process improvement projects.
• Support the implementation of digital tools and automated QA solutions.
• Take ownership of cross-functional projects and quality initiatives

Qualifications

• Bachelor's or Master's degree in Life Sciences, Chemistry, Biotechnology, Pharmacy, or a related scientific discipline.
• Experience within a GMP-regulated environment, preferably in pharmaceuticals, biopharmaceuticals, contract testing, or manufacturing.
• Strong knowledge of GxP regulations, quality systems, and data integrity requirements.
• Experience with deviations, CAPAs, change controls, risk assessments, and audits.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication skills and the ability to influence stakeholders at all levels.
• A proactive, hands-on attitude with a continuous improvement mindset.
• Fluency in English; Dutch is considered an advantage.

Additional Information

Eurofins BioPharma Product Testing Leiden B.V.: A world of possibilities

This position is based at Eurofins BioPharma Product Testing Leiden on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input. Eurofins BioPharma Product Testing Leiden also offers:

• A competitive salary;
• Flexible working hours;
• 25 days of vacation with the option to purchase 7 additional days (based on a fulltime contract);
• Travel allowance of 23 cents net per kilometer. Are you traveling by public transport? Then your travel expenses will be fully reimbursed via NS Business Card;
• Participation in a pension scheme with 50% contribution by Eurofins;
• Each month, you accumulate a choice budget balance of 8.95% of your gross salary. This includes, among other things, holiday pay and a year-end bonus. You can choose to have this amount paid out, or you can use it to buy extra days off, for example. You choose what suits you best;
• Discount on additional health insurance;
• Tax benefit via FiscFree when purchasing various products and services via your gross salary, such as a bicycle, sports contribution, fitness, mobile telephony, computers & tablets or a weekend away;
• Professional training and opportunities for training and development;
• Training options via the online learning platform Good Habitz.

Working at Eurofins BioPharma Product Testing Leiden offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for our employees:

• Diverse developmental opportunities within the organization;
• A large client portfolio ensures a lot of diversity in your work.