Celebrating 20 years of innovation - Discover how we've been a catalyst for regional growth and UK innovation for over two decades in CPI's Annual Review 2023-2024.
£26,500 - £34,500 per annum, dependent on experience.
CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.
Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.
From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.
Why this role is important for CPI’s work
CPI has an opportunity for a Quality Control Analyst to join the growing Quality team based at our Biologics RNA Centre of Excellence in Darlington.
The QC Analysts provide wide-ranging quality control support to the quality function, promoting and integrating quality into every aspect of our business. In this role, you will perform a variety of tasks in support of specific areas of the site quality control function, mainly focusing on the development, sustainability, and continued improvement of the CPI Biologics quality control function to meet GMP requirements.
Projects within CPI encompass a broad range of process technologies and novel measurement and analytical techniques. This is reflected in the diversity of customers and their expertise. This role requires expertise in biological analysis techniques with the ability to support in the validation of methods for use in the QC laboratory as well as providing training for colleagues.
Key tasks in the QC Analyst role will include (but are not limited to the below), please download the job description for full details available on the CPI careers page:
* To maintain consistent and documented compliance with all relevant Safety, Health and Environment (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality, and best practice requirements.
* To perform laboratory work and data analysis in a timely manner and to a high standard.
* To perform laboratory investigations and out of specification investigations to GMP standards.
* To perform method development and method validation activities.
* To perform the required release activities for raw materials and critical consumables.
* To review and approve risk assessments and validation documentation as required.
* To support the site Quality Management System including input into investigations and/or CAPAs.
The person we are seeking
• Educated to HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline plus significant industrial experience, or educated to Degree level (or equivalent) in a Scientific/Engineering discipline plus relevant industrial experience.
• Will possess significant quality control expertise and experience of operating within a GMP environment, developing and implementing systems for quality control activities.
• Will exhibit professional mastery of principles and practices in GMP quality control systems, gained in industrial environments.
• Can demonstrate evidence of knowledge sharing and network building practice across teams or groups.
• Has ability to apply theoretical and practical quality tools and techniques to contribute to business activities.
• Knowledge of EU Pharmacopeia standards and knowledge of EU GMP Guidelines inc. Annexes 1, 2 & 15.
It would be great if you also had:
• Knowledge and practical experience in the development and application of analytical techniques for the analysis of biological products.
• Experience in Raw Material testing and release.
• Knowledge and experience of Data Integrity principles.
• Chartered status with a relevant professional institution.
What does CPI offer you?
At CPI, we offer a wide range of benefits to our employees, this includes:
* Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme.
* Life assurance and accident insurance schemes.
CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.
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