Senior QC Data Reviewer – HPLC/UPLC & Data Integrity

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

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.