QC Analyst - Biologics Division

Company Overview

Charles River Laboratories has been advancing drug discovery, development, and safe manufacturing for over 75 years, impacting global health positively. Our collaboration with Boston Children’s Hospital amplifies this mission through innovation that enhances patient care worldwide. We value diverse talents and perspectives united to improve lives and foster a healthier future via compassion and innovation.

Job Summary

We are looking for a skilled QC Analyst to join our Biologics team in Ballina, Co. Mayo, Ireland. This position involves managing client testing projects and executing analytical laboratory tests, reporting to the Analytical QC Manager.

Key Responsibilities

• Manage routine batch release testing projects, including client communication, weekly meetings, subcontractor coordination, and adherence to testing schedules alongside team supervisors.
• Review raw data as needed, coordinate with Quality Assurance, and generate Certificates of Analysis (CoA).
• Create and maintain GMP-compliant Standard Operating Procedures (SOPs), protocols, and reports.
• Lead investigations into quality deviations and out-of-specification results.
• Conduct data trending analysis and provide additional client information as required.
• Support development, verification, and validation of analytical methods using HPLC, ion and gas chromatography, spectrophotometry, wet chemistry, and compendial techniques.
• Process test samples within the Laboratory Information Management System (LIMS).
• Comply with safe and proper disposal of laboratory-generated waste.
• Perform data calculations and apply basic statistical methods.
• Source, purchase, and maintain inventory of consumables, standards, and reagents for testing.
• Assist with internal, regulatory, and client audits and address findings accordingly.

Qualifications and Requirements

• A degree in biochemistry, biotechnology, biology, or a related scientific discipline.
• Proven experience with analytical techniques pertinent to this role.
• At least two years of relevant scientific research experience, preferably in a GMP-regulated environment (EMEA/FDA) within pharmaceutical, medical device, or contract research organizations.
• Project management experience is advantageous but not mandatory.

About Charles River Insourcing Solutions

Charles River Insourcing Solutions℠ enhances research efficiency and lowers costs by providing strategic insourcing of GMP, GLP, and non-GLP services, maintaining control over facilities and expertise while optimizing resources.

About Charles River

Charles River is a leading early-stage contract research organization offering a vast range of discovery and safety assessment services, including GLP and non-GLP compliant support, that facilitate drug development from target identification to preclinical testing. With over 20,000 employees across more than 110 locations worldwide, we serve clients including pharmaceutical companies, biotechnology firms, government agencies, hospitals, and academic institutions.

Commitment and Benefits

Our passion lies in improving lives through science and dedicated service. We have contributed to 80% of FDA-approved drugs in the past five years. Benefits may include performance bonuses, 401K plans, paid time off, stock purchase schemes, health and wellness programs, employee family support, and work-life flexibility.

Equal Opportunity Employment

Charles River is an equal opportunity employer that ensures nondiscriminatory employment practices. We provide accommodations for individuals with disabilities upon request during the application process.