R&D Partners
Quality Control Validation Analyst
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Join the forefront of biotechnology and ensure the quality, accuracy, and compliance behind next-generation gene therapy products.
R&D Partners is seeking a Quality Control Validation Analyst to join a leading biotechnology company.
The Quality Control Validation Analyst is responsible for the validation, qualification, and transfer of both new and existing analytical test methods used to assess advanced biological products and related manufacturing materials. The role supports GMP-compliant laboratory operations and ensures testing activities meet applicable regulatory requirements and quality standards for commercial and clinical manufacturing.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Develop, validate, and transfer analytical test methods for existing and emerging gene therapy products.
- Prepare validation protocols, analyze data, and generate reports to support method lifecycle activities.
- Ensure analytical methods comply with GMP regulatory guidelines and data integrity principles.
- Create, update, and maintain method-related SOPs, ensuring timely communication of method transfer progress.
- Conduct routine performance assessments of analytical methods and support Quality Management System activities.
- Complete training documentation and GMP actions (e.g., CAPAs, change controls, audit responses) within required timelines.
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Key Skills and Requirements:
- Degree or Master's in a scientific or health-related discipline.
- Minimum of 2 years of experience in a pharmaceutical or similarly regulated environment.
- Hands-on experience in analytical method validation within research or GMP settings.
- Preferably experienced with qPCR, HPLC (RP-HPLC, SEC), ELISA, SDS-Western blot, cell culture, and DNA extraction.
- Knowledge of ICH Q2(R1) guidelines.
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R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.
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