QA Reviewer

Complete Laboratory Solutions; Limerick; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Professional development

Training opportunities

Collaborative environment

Benefits package

Job summary

Complete Laboratory Solutions is seeking an experienced Analytical Scientist to support laboratory operations, analytical testing, method validation, equipment maintenance, and data review in a regulated GLP/GMP environment.

You will also provide technical support to the team, lead troubleshooting activities, and contribute to continuous improvement and compliance initiatives, with travel as required.

Qualifications

• Strong technical knowledge with troubleshooting HPLC, dissolution, and standard analytical instrumentation.
• Proficient in audit trail review and data integrity within regulated systems.
• Experience investigating analytical issues and resolving out-of-specification results.

Responsibilities

• Deputize for Analytical Team Leader and provide technical support to the team.
• Maintain knowledge of Agilent HPLCs, Empower, Winsotax, and LIMS.
• Carry out projects to implement new specifications and analytical methods as required.
• Receive and log samples, schedule testing, and support lab release processes.
• Monitor and verify laboratory equipment and complete documentation.

Skills

HPLC troubleshooting

Data integrity

Documentation skills

Travel willingness

Education

BSc or MSc in a relevant field

Tools

Agilent HPLC

Empower

LIMS

Winsotax

Job description

Overview

CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dedicated, solutions driven team members with a flexible approach, who want to be part of the company’s continued success.

Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland, providing industry-leading sampling and analysis; and fully trained micro and analytical analysts on contract to clients in the food, environmental, medical device, biopharmaceutical, and pharmaceutical sectors.

We offer bespoke managed service solutions that give clients the option of having our expert team on-site at their own facility or outsourcing those services to us here at CLS.

The Role

We are seeking an experienced Analytical Scientist to support laboratory operations, analytical testing, method validation, equipment maintenance, and data review activities within a regulated GLP/GMP environment. This role will also provide technical support to the team, lead troubleshooting activities, and contribute to continuous improvement and compliance initiatives.

Key Responsibilities

• Deputize for the Analytical Team Leader as required, including providing technical and problem-solving support to the team.

• Maintain in-depth knowledge of Agilent HPLCs, Empower, Winsotax software, and LIMS.

• Carry out project work associated with implementing new specifications and analytical methods required by pharmacopeial or customer requirements.

• Receive and log samples for testing, schedule testing activities, and support laboratory release processes.

• Monitor and verify laboratory equipment and complete associated documentation.

• Perform instrument calibration and maintenance and complete associated records.

• Review and approve calibration and maintenance documentation as required.

• Support development of new methods and perform validation activities.

• Review and approve laboratory testing data and reports for release testing of finished products and raw materials.

• Review and approve laboratory investigations in a timely manner.

• Troubleshoot and investigate out-of-specification results.

• Participate in internal and external audits and support implementation of CAPA actions.

• Comply with GLP, GMP, and safety requirements at all times.

• Maintain the laboratory in a clean and organised condition.

• Provide monthly reports and quality metrics as required.

Who You Are

• Strong technical knowledge with the ability to troubleshoot HPLC, dissolution, and other standard analytical instrumentation.

• Proficient in audit trail review and data integrity assessment within regulated laboratory systems.

• Experienced in investigating analytical issues and resolving out-of-specification results.

• Detail-oriented with strong documentation and data review skills.

• Highly organised with good computer literacy skills.

• Willing and available to travel for business purposes when required.

Where You Come From

• BSc, Masters degree, or equivalent relevant experience desirable.

• Ideally 5 years of experience in a GLP/GMP analytical laboratory environment within the pharmaceutical or medical device industry preferred.

• Experience working with analytical instrumentation, laboratory systems, and regulated testing environments.

• Knowledge of method development, validation, calibration, maintenance, and laboratory compliance activities.

What We Offer

• Competitive salary and benefits package.

• Opportunities for professional development and training.

• Exposure to a variety of analytical projects and technologies.

• A collaborative and quality-focused working environment.

• The opportunity to contribute to continuous improvement and compliance initiatives.