Join us to apply for the QA Officer role at Charles River Laboratories
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.
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 online 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 of 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
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 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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