Requirements:

• 40hour week
• Hybrid: 2 days on site, 3 from home
• Location: Rotterdam

As our Quality Assurance Officer, you will be an integral part of our Quality Control team, working to safeguard the integrity and efficacy of our life-changing products. Your responsibilities will include:

• Conducting comprehensive quality control testing on a wide range of biotechnology products, including gene therapies and personalized medicine formulations
• Utilizing advanced analytical techniques such as HPLC, GC-MS, qPCR, and next-generation sequencing
• Analyzing and interpreting complex data sets to ensure product quality and consistency
• Investigating deviations, non-conformances, and out-of-specification results
• Developing and optimizing quality control procedures and test methods
• Maintaining detailed documentation in compliance with FDA regulations and GMP guidelines
• Collaborating with interdisciplinary teams including R&D, Manufacturing, and Regulatory Affairs
• Participating in internal and external audits to ensure ongoing compliance
• Contributing to continuous improvement initiatives and lean manufacturing processes

Qualifications

The ideal candidate will possess:

• A bachelor’s or master’s degree in Biochemistry, Biotechnology, Molecular Biology, or a related field
• 3+ years of hands-on experience in quality control within a GMP-regulated biopharmaceutical or biotechnology setting
• Proficiency in a wide range of analytical techniques, with expertise in at least two of the following: HPLC, GC-MS, qPCR, flow cytometry, or next-generation sequencing
• Strong understanding of FDA regulations, ICH guidelines, and GMP requirements
• Excellent problem-solving skills with a keen eye for detail
• Outstanding written and verbal communication abilities
• The capacity to work both independently and collaboratively in a fast-paced, dynamic environment
• Experience with quality management systems and laboratory information management systems (LIMS) is a plus

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

Ryan Griffin