QC Analyst

Charles River Laboratories; Ballina; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Bonus incentives

401K

Paid time off

Stock purchase program

Health and wellness coverage

Employee and family wellbeing support

Work life balance flexibility

Job summary

Charles River Insourcing Solutions in Ballina, Co. Mayo, Ireland, seeks an experienced QC Analyst for the Biologics Division. The role combines project management of client testing with hands-on analytical work in a GMP laboratory, reporting to the Analytical QC Manager.

Responsibilities include GMP-compliant SOPs, investigations, data trending, method verification/validation, LIMS processing, waste disposal, and supporting client visits and audits.

Qualifications

• Degree in a relevant science discipline (biochemistry, biotechnology or biology).
• Analytical techniques experience is essential for this role.
• Minimum 2 years relevant GMP-regulated experience (EMEA/FDA) in Pharma/Medical Device/CRO.
• Project management experience is beneficial but not essential.

Responsibilities

• Project Management of routine batch release testing in Analytical Services (client correspondence, weekly calls, subcontractors, timelines, sample release, testing scheduling, QA liaison, CoA generation).
• Generate and update GMP-compliant SOPs, protocols and reports.
• Lead quality investigations into OOS results and deviations.
• Carry out data trending and provide information to clients as required.
• Assist in developing/verification/validation of analytical methods (HPLC, IC, GC, spectrophotometry, wet chemistry).
• Process test samples in LIMS; ensure safe disposal of lab waste.
• Perform data calculations and basic statistics.
• Source, purchase and stock consumables and reagents for testing.
• Support internal/regulatory/client visits and respond to findings.

Skills

Project management

Analytical testing

GMP experience

LIMS

Data analysis

Statistics

Education

Degree in biochemistry/biotechnology/biology

Tools

HPLC

Ion chromatography

Gas chromatography

Spectrophotometry

Wet chemistry

Compendial methods

Job description

For 75 years, Charles River employees have worked to advance the discovery, development, and safe manufacture of new drug therapies, making a profound impact on global health. Our 20-year partnership with Boston Children’s Hospital takes this mission to the next level, supporting groundbreaking innovations that directly impact patient care. At Boston Children’s, their commitment to diversity drives the exceptional quality of care provided to patients from local communities to over 160 countries worldwide. This is your moment to become part of a family where unique talents and perspectives unite to change lives, including your own. Together, we’re shaping a healthier future through compassion, innovation, and opportunity.

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 Insourcing Solutions

Charles River Insourcing Solutions can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions provides you with the ability to maintain control of your facility and expertise while leveraging available space.

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.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [e-mail]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.