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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.
Job Summary
We are seeking an experienced Quality Auditor (Fixed Term Contract for 12 months to cover maternity leave) for our Biologics Division located in Ballina, Co. Mayo, Ireland.
This role will report to the QA Manager, and the main duties & responsibilities include:
* Perform general auditing duties for compliance with quality standards.
* Prepare written reports on audit and inspection activities.
* Review SOPs.
* Assist in the administration of the Quality Department and Quality systems.
* Assist with Vendor Assessment, client audits, and subcontractor audits.
Job Qualifications
The following are minimum requirements for the Quality Auditor position:
* Experience working within a GLP/GMP environment is preferable but not essential.
* Previous quality auditing experience is preferable.
* Meticulous attention to detail and high accuracy.
* Comfortable working with calculations.
* Ability to work independently and within a team.
* Excellent interpersonal and communication skills, both written and verbal.
* IT Skills – MS Word, Excel, PowerPoint.
About Biologics Testing Solutions
With over 50 years of experience and proven regulatory expertise, the Charles River Biologics group addresses challenging projects for biotechnology and pharmaceutical companies worldwide. We offer services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies, and stability and lot release programs. We support clients throughout the biologic development cycle, from cell bank establishment to clinical studies and marketed products. Our team can create custom solutions to meet client needs, supporting over 20,000 biologic testing reports annually and more than 200 licensed products.
About Charles River
Charles River is an early-stage contract research organization (CRO). We provide a diverse range of discovery and safety assessment services, supporting clients from target identification through preclinical development, including clinical laboratory testing and manufacturing support. With over 20,000 employees across 110 facilities in more than 20 countries, we are positioned to coordinate worldwide resources and apply multidisciplinary perspectives to solve our clients’ challenges. Our client base includes global pharmaceutical and biotech companies, government agencies, hospitals, and academic institutions.
Our mission is to improve the quality of people’s lives through excellent science and a strong sense of purpose. We are committed to diversity and inclusion, recognizing and recruiting talent from all backgrounds.
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