QC Analytical - Data Reviewer

CLS - Complete Laboratory Solutions; Galway; On-site; EUR 42,000 - 64,000; Full time

Job summary

CLS - Complete Laboratory Solutions in Galway, Ireland, seeks a detail-oriented QC Data Review Analyst to join our team. The role centers on reviewing HPLC/UPLC data, ensuring GDP and ALCOA+ compliance, and maintaining data integrity across records.

You will verify results against specifications, support investigations and CAPA activities, and contribute to audits and regulatory inspections, ensuring right-first-time documentation and traceability.

Qualifications

• Degree in Chemistry, Analytical Science, or a related field.
• Minimum of 2 years' experience working within a QC laboratory in a GMP-regulated environment.
• Strong hands-on experience with HPLC/UPLC and a solid understanding of chromatographic integration and system suitability requirements.
• Knowledge of GDP and Data Integrity principles (ALCOA+).
• Excellent attention to detail, organisational skills, and the ability to review complex data accurately.

Responsibilities

• Perform second-person review of HPLC/UPLC data, including chromatograms, integration events, system suitability results, sample and standard preparations, and calculations.
• Verify analytical results against specifications, test methods, and relevant pharmacopoeial requirements.
• Review laboratory documentation, including worksheets, logbooks, and notebooks, ensuring compliance with GDP and ALCOA+ principles.
• Review electronic laboratory data and audit trails, reconciling information against associated laboratory records.
• Confirm instrument qualification status, calibration and maintenance records, and traceability of reference standards and reagents.
• Identify, document, and elevate errors, data discrepancies, out-of-specification (OOS) or out-of-trend (OOT) results, and data integrity concerns.
• Support laboratory investigations and CAPA activities arising from data review observations.
• Provide constructive feedback to laboratory analysts to promote right-first-time documentation and data quality.
• Support internal audits, customer audits, and regulatory inspections as required.

Skills

HPLC/UPLC

Data integrity (ALCOA+)

Data review

Quality documentation

Education

Chemistry/Analytical Science degree

Tools

CDS (Chromatography Data System)

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.

Key Responsibilities

• Perform second-person review of HPLC/UPLC data, including chromatograms, integration events, system suitability results, sample and standard preparations, and calculations.
• Verify analytical results against specifications, test methods, and relevant pharmacopoeial requirements.
• Review laboratory documentation, including worksheets, logbooks, and notebooks, ensuring compliance with Good Documentation Practices (GDP) and ALCOA+ principles.
• Review electronic laboratory data and audit trails, reconciling information against associated laboratory records.
• Confirm instrument qualification status, calibration and maintenance records, and traceability of reference standards and reagents.
• Identify, document, and elevate errors, data discrepancies, out-of-specification (OOS) or out-of-trend (OOT) results, and data integrity concerns.
• Support laboratory investigations and CAPA activities arising from data review observations.
• Provide constructive feedback to laboratory analysts to promote right-first-time documentation and data quality.
• Support internal audits, customer audits, and regulatory inspections as required.

Requirements

Essential

• Degree in Chemistry, Analytical Science, or a related scientific discipline.
• Minimum of 2 years' experience working within a QC laboratory in a GMP-regulated environment.
• Strong hands-on experience with HPLC/UPLC and a solid understanding of chromatographic integration and system suitability requirements.
• Knowledge of Good Documentation Practices (GDP) and Data Integrity principles (ALCOA+).
• Excellent attention to detail, organisational skills, and the ability to review complex data accurately.

Desirable

• Previous experience reviewing laboratory data within a pharmaceutical manufacturing environment.
• Experience supporting investigations, deviations, and CAPA activities.
• Familiarity with chromatography data systems (CDS) and audit trail review.

Complete Laboratory Solutions (CLS) is committed to creating a diverse, inclusive, and equal workplace where everyone is treated with respect and given the opportunity to succeed. We are proud to be an Equal Opportunities Employer and welcome applications from all qualified candidates regardless of background, gender, age, disability, ethnicity, religion, sexual orientation, or any other protected characteristic.