QC Data Reviewer - HPLC/UPLC & GMP Compliance

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

Job summary

Complete Laboratory Solutions is seeking a QC Analytical - Data Reviewer in Galway to join a high‑growth contract laboratory. You will review HPLC/UPLC data, confirm system suitability and calculations, and ensure GDP and ALCOA+ compliance across documentation and records.

The role requires 2+ years in a GMP QC lab, strong chromatographic expertise, and meticulous data review. You will support audits, CAPA activities, and regulatory inspections as needed.

Qualifications

• 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 chromatographic integration.
• 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.

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 escalate errors, data discrepancies, OOS or 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 proficiency

GDP & ALCOA+ data integrity

Attention to detail

Education

Degree in Chemistry, Analytical Science, or related discipline

Tools

CDS (Chromatography Data Systems)

Job description

Complete Laboratory Solutions is seeking a QC Analytical - Data Reviewer in Galway to join a high‑growth contract laboratory. You will review HPLC/UPLC data, confirm system suitability and calculations, and ensure GDP and ALCOA+ compliance across documentation and records.

The role requires 2+ years in a GMP QC lab, strong chromatographic expertise, and meticulous data review. You will support audits, CAPA activities, and regulatory inspections as needed.