Job Description

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 Overview

We are seeking an experienced QC Analyst for our Biologics Division located in Ballina, Co. Mayo, Ireland.

This role shall involve both project management of clients testing and conducting analytical testing in the laboratory. This role shall report to the Analytical QC Manager.

Main duties & responsibilities

Project Management of routine batch release testing in the Analytical Services Department (client correspondence,/weekly calls, management of subcontractors, ensuring samples are released within the required timelines i.e. scheduling of tests in cooperation with team supervisors, review of raw data as required, liaising with QA, generation of CoA etc.)

• Generation and updating of GMP compliant SOPs, Protocols and reports.
• Leading Quality investigations into out of specification results and unplanned deviations
• Carry out data trending. Provide additional information at the clients request as required.
• Assist in developing and/or verification/validation of analytical methods that use equipment like HPLC, Ion and Gas Chromatography, spectrophotometers as well as wet chemistry techniques and compendial methods.
• Receipt and processing of test sample in LIMS
• Safe and compliant disposal of all laboratory generated waste.
• Carry out data calculations and basic statistics.
• Sourcing, purchasing and stocking consumables, standards and reagents required for testing.
• Assist in internal, regulatory and client visits/audits and respond to findings as required.

Qualifications & Requirements

• Degree in a relevant science discipline (e.g. biochemistry, biotechnology or biology)
• Analytical techniques experience is essential for this role.
• Minimum 2 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device or CRO Industry.
• Experience of project management beneficial but not essential.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterzation, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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 supported the development of 80% of the drugs approved by the FDA in the last 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.