Join to apply for the Quality Operations Specialist role at Charles River Laboratories
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For nearly 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.
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 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 efficiencies.
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 over 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 the principle of diversity and inclusion and work daily in this direction.
228081
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
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* Job function
Science
* Industries
Automation Machinery Manufacturing
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