QC Analyst

Aphex Group; Waterford; On-site; EUR 42,000 - 64,000; Full time

Job summary

Aphex Group in Ireland seeks a dedicated analytical chemist to provide testing and data review across site operations, ensuring compliance with cGMP/cGLP standards. You will support release of materials and finished products, and maintain methods, specs, and SOPs in line with regulatory expectations.

The role requires meticulous documentation, strong attention to detail, and effective cross-functional collaboration with QA, Production, Engineering, Planning, and QC teams to uphold data integrity

Qualifications

• GMP-regulated lab experience in analytical chemistry.
• Strong documentation and data integrity skills.
• Experience reviewing data and laboratory records.
• Excellent cross-functional collaboration and communication.

Responsibilities

• Perform and review analytical testing and laboratory data.
• Investigate OOS results and support data trending and CoA generation.
• Maintain methods, specifications, and SOPs per regulatory requirements.
• Review notebooks, reports, and quality documentation.
• Support equipment qualification and validation (IQ/OQ/PQ).
• Train analysts on methods and updates as required.
• Collaborate with QA, Production, Engineering, Planning, and QC teams.
• Ensure compliance with cGMP/cGLP, data integrity, and lab quality standards.

Skills

Analytical chemistry

GMP experience

Data integrity

Documentation

Cross-functional

Tools

ELISA

UV analysis

Osmolality testing

SDS-PAGE

Biacore

HIAC

Job description

Purpose

Provide analytical chemistry testing and support to site operations, ensuring compliance with cGMP/cGLP requirements and supporting the release of raw materials, intermediates, and finished products.

Key Responsibilities

• Perform and review analytical testing and laboratory data.


• Investigate and document OOS results and support data trending and CoA generation.


• Maintain analytical methods, specifications, and SOPs in line with regulatory requirements.


• Review laboratory notebooks, analytical reports, and quality documentation.


• Support equipment qualification and validation activities (IQ/OQ/PQ).


• Train analysts on methods, procedures, and updates as required.


• Collaborate with QA, Production, Engineering, Planning, and QC teams.


• Ensure compliance with cGMP, cGLP, data integrity, and laboratory quality standards at all times.

Required Skills & Experience

• Analytical chemistry experience in a GMP-regulated environment.


• Strong understanding of cGMP/cGLP requirements.


• Excellent attention to detail and documentation skills.


• Experience reviewing analytical data and laboratory records.


• Strong communication and cross-functional collaboration skills.


• Preferred Experience


• ELISA


• UV analysis


• Osmolality testing


• SDS-PAGE


• Biacore receptor-binding assays


• HIAC particulate testing


• Strong micropipetting technique and time management skills.