For nearly 75years, 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. Job Summary Our fabulous Charles River Microbial Solutions International Ltd colleagues in Dublin are currently looking for a Quality Operations Specialist. This is a new role primarily based within the Accugenix Laboratory and is a fantastic opportunity for anyone looking to gain invaluable experience at the beginning of their QA career. - Perform release activities to support Laboratory, Warehouse and Instrument Services. - Approve customer test reports and participate in reagent release activities to support laboratory operations. - Review SOPs, protocols/batch records, reports, quality and regulated QMS records. (e.g. deviations, change controls, or CAPA) involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies. - Participate in the support of client site visits. - Participate in the performance of internal facility inspections. - Perform facility and equipment records and logbook reviews. - Participate in execution of Quality Assurance projects. - Assist with providing basic regulatory training to operations personnel. - Participate in the preparation of support during regulatory / customer, as required. - Assist in correction of any regulatory risk areas as identified by Senior Quality Systems team members. - Assist with analysis and collection of site Quality Metrics via QMS. - Provide timely responses to Customer inquiries to support their qualification / regulatory requests. - Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings. Charles River Laboratories offer a competitive remuneration and benefits package for this role together with on:going learning and development opportunities and structured career progression schemes. Job Qualifications - Education: Bachelor's degree (B.S. / BA.A.) or equivalent, preferably in a life science. - Experience: This is an entry level role. Whilst some experience within a laboratory based QA role would be advantageous full training will be provided. An aptitude for life sciences and an ethusiasm for learning are essential. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. - Other: Some experience with Microsoft Office(R) applications. This position requires the ability to communicate clearly, effectively and professionally; easily grasp instructions without follow:up; attention to detail and strong writing skills are essential. - Attributes: This role is suited to someone who is highly self motivated, well organised and can maintain excellent focus when dealing with large volumes of work of a repetitive nature. Additional Information: This role is based onsite. 37.5 hours standard week Monday : Friday inclusive. About Microbial Solutions Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever:changing needs of the industry. We help clients to ensure product safety and quality with easy:to:use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational e