Sr QA Specialist
Sr QA Specialist
Rotterdam
Netherlands
£60,000/year
Permanent
Research & Development
1
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
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