Senior QC Analyst

Desired Skills: HPLC,Chromeleon Software,OOS

QA Resources have an opportunity for a Sr QC Analyst role to be based on client site in East Cork:

Contract to year end, Shift role

Role Overview

The Senior QC Analyst will be responsible for performing and overseeing analytical testing within a GMP-regulated laboratory, with a strong focus on HPLC-based methods. The role requires a high level of technical expertise, data integrity awareness, and the ability to operate independently while supporting continuous improvement and compliance initiatives.

Responsibilities (may include but not limited to):

• Perform routine and non-routine analytical testing using HPLC techniques, including:
• Assay and related substances
• Impurities profiling
• Dissolution and content uniformity testing
• Execute validated analytical methods and ensure adherence to GMP requirements
• Conduct stability and shelf-life testing using chromatography systems
• Review analytical data, including chromatograms, integrations, and audit trails
• Troubleshoot chromatographic and instrumentation issues effectively
• Support laboratory investigations, including OOS (Out of Specification) and OOT (Out of Trend) results
• Ensure all work complies with GMP, GDP, and data integrity (ALCOA+) principles
• Maintain accurate and complete documentation in line with regulatory expectations
• Participate in internal and external audits/inspections as required
• Support equipment lifecycle activities, including IQ/OQ/PQ, calibration, and maintenance
• Manage workload effectively in a high-throughput QC or stability environment

Requirements:

• Minimum 4+ years’ hands-on experience in a GMP laboratory environment
• Strong practical experience with HPLC instrumentation (e.g. Waters, Agilent, Thermo, Shimadzu)
• Proven experience using Chromeleon CDS (Thermo Fisher)
• Experience with Empower or OpenLab is advantageous
• Demonstrated experience in:
• Routine HPLC testing
• Stability testing
• Method execution
• Data review and audit trail assessment
• Strong troubleshooting and problem-solving capabilities
• Degree in Chemistry, Analytical Science, Pharmaceutical Science, or related discipline (preferred)

• Experience mentoring or training junior analysts
• Exposure to equipment qualification (IQ/OQ/PQ) processes
• Audit and inspection readiness experience

Interested candidates should send their CV to niamh.mcdonald@peglobal.net