Why this role is important for CPI’s work
We are currently recruiting for an experienced QC Analyst to join the growing Quality team in our new QC facility based at our Biologics RNA Centre of Excellence in Darlington. The team are supporting the Biologics business unit move to GMP activities.
The QC Analyst will report to the Senior QC Specialist and will 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 continuous improvement of the CPI Biologics quality control function to meet GMP requirements. You will support activities for implementing QC QMS and a new QC laboratory facility working with the wider Biologics team for method transfer and equipment qualification.
The role is offered on a hybrid basis, with a combination of home and onsite working.
Quality is a key foundation of our business and through effective quality management, CPI will continue to add value to the company and help achieve its business goals. The focus of this role is to provide wide-ranging support to the quality function, promoting and integrating quality into every aspect of our business.
Projects within CPI encompass a broad range of process technologies and novel measurement and analytical techniques, and this is reflected in the diversity of customers and their expertise. CPI can offer successful candidates the opportunity to work with a range of customers and innovative projects
Key responsibilities will include:
- Perform all Quality Control duties and tasks in accordance with relevant GMP guidelines.
- Calibration and monitoring of analytical equipment
- Support the site Quality Management System including input into investigations and/or CAPAs
- Perform laboratory investigations and out of specification investigations to GMP standards
- Author, review and approval of SOPs, methods and specifications
- Support both internal and external audits including writing reports, agreeing CAPA and following these up as required
- Perform method development and method validation activities
- Review and approval of risk assessments and validation documentation as required
The person we are seeking
The successful candidate will be educated to a minimum of HNC or Foundation Degree level (or equivalent) in a Scientific/Engineering discipline plus hold significant industrial experience, ideally, you will be educated to degree level in one of these disciplines and hold relevant experience.
It is essential that candidates have knowledge of EU Pharmacopeia standards and EU GMP Guidelines including Annexes 1, 2 & 15.
Candidates will also possess significant quality control expertise and experience in operating within a GMP environment, developing and implementing systems for quality control activities.
The successful candidate will also be able to demonstrate the following:
Professional mastery of principles and practices in GMP quality control systems gained in industrial environments.
Ability to work in a fast-paced environment, flexibility to adjust with moving priorities and ensuring attention to detail remains first class.
Ability to apply theoretical and practical quality tools and techniques to contribute to business activities.
Provide examples of actively utilising cross-team collaboration to achieve desired results.
Confidence to use own judgement and initiative within standard quality practices, as well as an understanding of when to seek advice from colleagues.