Senior QC Analyst

CREGG Group; Limerick; On-site; Confidential; Full time

Job summary

The CREGG Group in Limerick is seeking a Senior QC Analyst to act as SME in QC Laboratory, directing and performing analytical methods for raw materials, in-process samples, stability, and finished products. This role also supports environmental testing, validation, stability and related lab testing.

Key duties include executing and validating test methods (HPLC, GC, KF, FTIR, UV-VIS), leading training, contributing to CAPAs, supporting OOS investigations, maintaining SOPs for cGMP compliance,

Qualifications

• 7+ years of relevant experience
• Subject matter expert in Analytical Sciences
• Excellent proficiency with HPLC, GC, KF, FTIR, and other wet chemistry methodology
• Experience working in an ISO or FDA regulated environment
• Expertise with Empower
• Expertise in transfer validation, test method transfer, test method validation

Responsibilities

• Execute and validate test methods for raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, and traditional quantitative analysis utilizing HPLC, GC, and/or traditional wet chemical testing.
• Adhering to all Quality and Safety requirements on site and supporting Quality and Safety initiatives as required.
• Lead training of all new employees and maintain all training documentation via current system
• Support the OOS system Laboratory Investigations, and assist in any related CAPAs, deviations, etc
• Perform advanced chemical testing using analytical instrumentation including HPLC, GC, FTIR, UV-VIS, etc.
• Provide help with troubleshooting of analytical instrumentation and advanced maintenance
• Facilitate QC audit readiness with understanding of FDA and ISO regulations and requirements
• Apply compliant laboratory techniques as per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal & customer requirements.
• Assist in writing and revising SOPs and WIs to ensure cGMP compliance.

Education

Degree or Masters in Chemistry

Tools

HPLC

GC

KF

FTIR

UV-VIS

Empower

Job description

Senior QC Analyst

Excellent opportunity for a Senior QC Analyst to join a thriving company in Limerick. The Senior QC Analyst will serve as a subject matter expert in the QC Laboratory & will direct and perform analytical methods for complex testing on raw materials, in process samples, stability, and finished products. The Senior QC Analyst will also provide support for environmental testing, validation, stability and other various laboratory and production testing as needed.

Key Responsibilities

• Execute and validate test methods for raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, and traditional quantitative analysis utilizing HPLC, GC, and/or traditional wet chemical testing.
• Adhering to all Quality and Safety requirements on site and supporting Quality and Safety initiatives as required.
• Lead training of all new employees and maintain all training documentation via current system
• Support the OOS system Laboratory Investigations, and assist in any related CAPAs, deviations, etc
• Perform advanced chemical testing using analytical instrumentation including HPLC, GC, FTIR, UV-VIS, etc.
• Provide help with troubleshooting of analytical instrumentation and advanced maintenance
• Facilitate QC audit readiness with understanding of FDA and ISO regulations and requirements
• Apply compliant laboratory techniques as per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal & customer requirements.
• Assist in writing and revising SOPs and WIs to ensure cGMP compliance.

Key Requirements

• Degree or Masters in Chemistry or related scientific field
• Minimum 7 years relevant experience
• Subject matter expert in Analytical Sciences
• Excellent proficiency with HPLC, GC, KF, FTIR, and other wet chemistry methodology
• Experience working in an ISO or FDA regulated environment
• Expertise with Empower
• Expertise in transfer validation, test method transfer, test method validation
• Excellent communication & interpersonal skills
• Ability to problem solve and make decisions that are GMP compliant.
• Ability to read and execute compendia methods from USP