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
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 effectivelySupport 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)
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)
Desirable / Advantageous
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 Audrey.mccarthy@qaresources.com
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