Quality Assurance Specialist
hace 5 días
Job Description:
At Moderna Therapeutics, we are revolutionizing the field of medicine with our mRNA technology platform.
We are seeking a Quality Assurance Specialist - Chemistry & Stability to join our team in Madrid, Spain. As a key member of our quality control team, you will be responsible for ensuring the stability and quality of our products.
About the Role:
As a Quality Assurance Specialist - Chemistry & Stability, you will be responsible for conducting trending and statistical analyses, creating and managing stability protocols, reports, and GMP stability study documents, supporting stability chamber maintenance, troubleshooting, and data interpretation, assisting with regulatory submissions by providing stability data and reports, and managing inventories for GMP stability drug substance and products.
Your Key Responsibilities Will Include:
- Conducting trending and statistical analyses per ICH guidelines
- Creating and managing stability protocols, reports, and GMP stability study documents
- Supporting stability chamber maintenance, troubleshooting, and data interpretation
- Assisting with regulatory submissions by providing stability data and reports
- Managing inventories for GMP stability drug substance and products
- Coordinating stability pulls, set-downs, and external sample shipments
- Participating in Quality Event resolutions, including Deviations, CAPAs, and Change Controls
- Supporting stability program continuous improvement initiatives
- Compiling metrics for quality management reviews and stability meetings
- Contributing to audits, safety compliance, and cross-functional stability team discussions
Requirements:
We are looking for a highly motivated and experienced professional with a Bachelor's degree in Chemistry (or relevant scientific discipline) and at least 5-7 years of experience in quality control laboratory of a pharmaceutical company. You should have hands-on experience with analytical chemistry testing including chromatographic techniques, spectroscopic and spectrometric techniques, physical properties techniques such as particle analysis by dynamic light scattering, titration techniques, and others. You should also have experience with stability testing and related activities such as maintaining of stability databases, trending and statistical analyses, creation, revision, review, and approval of SOPs, stability protocols, and reports in accordance with current GMP, FDA, EU, and ICH guidelines and regulations.
What We Offer:
We offer a competitive salary of €60,000 - €80,000 per annum, depending on experience, plus a range of benefits, including comprehensive health insurance, life insurance, pension plan, paid vacation days, and opportunities for career growth and professional development.
About Us:
Moderna Therapeutics is a biotechnology company that is pioneering the use of mRNA technology to develop novel therapeutics. Our mission is to create a new generation of medicines that can be used to prevent and treat diseases.
Location:
This position is based in Madrid, Spain, and requires full-time attendance at our site.
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