Quality Assurance Officer 1
Keele, GB, ST5 5SP
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Our Keele site is looking to recruit an Operational Quality Assurance Officer on a permanent, full time basis. The ideal candidate will have experience of working in a Quality role, to GMP standards but this not essential as full comprehensive training will be provided to the successful candidate. This role is based in both the GMP manufacturing facility and office space working.
As part of the role you will need to have excellent attention to detail, have a pro active approach to problem solving, be able to effectively communicate, both verbally and in writing. The role will require you to be able to manage priorities whilst working both as part of a team and independently in a fast paced environment.
The main duties will include:
• Provide ‘in suite’ operational QA oversight and assistance on quality related issues within the GMP manufacturing Grade D and Grade C Facility.
• Provide Facility Systems support, including review and approval of HVAC Pressures, Temperature, and Cleaning Logs,
• Perform ‘in suite’ Room Inspections and Release.
• Issue, review and approval of GMP batch manufacturing records to support QP certification and release.
• Assist in performance of internal self-inspection audits
• Generation, review and approval of relevant quality documentation
• Support with assessment of deviation event investigations
• Support closure to plan of Change Controls and CAPA actions.
• Assist and lead continuous improvement projects
• Review and approval of Validation reports.
• Archiving of operational and quality control documentation
Profile and Requirements
• Ideally Science degree or equivalent, with proven relevant experience in a pharmaceutical Manufacturing or Quality Assurance role.
• You will have good working knowledge of GMP, ideally in the pharmaceutical sector but this is not essential - full training will be provided.
• Or, minimum A Level qualifications in Science with 2 years experience in an operational Quality Assurance role working to GMP standards.
This role will be based at Keele, Staffordshire. Therefore, candidates must be able to travel to this site on a daily basis.
About Charles River’s CDMO Services
With over 20 years of experience and industry-leading expertise, Charles River’s cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities—including plasmid DNA, viral vector, and cell therapy manufacturing—enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to fostering a sense of belonging and work daily in this direction.
For more information, please visit www.criver.com.