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.
We have an exciting QA Officer opportunity at our site in Keele. This is a unique role that gives experience in both quality systems and quality operations sides of the quality assurance function. You will join as part of the QA team reporting to the QA Manager. You will be responsible for maintenance of the site supplier assurance program and performing online facility QA operations reviews, working alongside the operations team to ensure compliance to SOPs and GMP standards throughout manufacture.
Key Responsibilities
* Participate in the preparation of Vendor Risk Assessments
* Track, Monitor, and Maintain Vendor Qualification and Re-Qualification, and respective documentation
* Review Vendor Qualification Documentation and Vendor Change Notifications
* Maintain the Keele Approved Vendor List
* Review Vendor Past Performance
* Archive all Qualification Documentation and Agreements
* Perform on line QA reviews of manufacturing within the GMP facility, to ensure production meets the highest standard of quality and compliance throughout manufacture
* Support performance of GMP facility line clearance inspections and room release
* Support Change Control, Deviation and CAPA management
* Review of Material Specification Sheets
Key skills
* Good communication, both verbal and written
* High levels attention to detail
* Enthusiasm to look for process improvement ideas
* Proficient in Microsoft Word and Excel,
* Strong administration skills
Experience (desirable but not essential)
* Understanding of GMP or other regulated environment
* Previous Supplier/vendor assurance experience
* Previous QA Experience
* Working within Grade D/Grade C cleanrooms
* Knowledge of Sharepoint, Smartsheet and SAP
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.
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