Overview

CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dedicated, solutions driven team members with a flexible approach, who want to be part of the company’s continued success.

Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland, providing industry-leading sampling and analysis; and fully trained micro and analytical analysts on contract to clients in the food, environmental, medical device, biopharmaceutical, and pharmaceutical sectors.

We offer bespoke managed service solutions that give clients the option of having our expert team on-site at their own facility or outsourcing those services to us here at CLS.

The Role

The Senior QC Microbiologist will be responsible for the delivery of routine and non-routine microbiological and analytical testing in support of GMP drug substance/product manufacture, with particular emphasis on endotoxin and TOC (Total Organic Carbon) testing, environmental monitoring review, and investigation writing. The role carries SME-level responsibility for training delivery and technical review within the QC Microbiology function.

Key Responsibilities

Perform and review Environmental Monitoring (EM) data in line with site procedures and GMP
requirements
Conduct and review Endotoxin (LAL) testing across raw materials, in-process, and water/utility systems
Perform Total Organic Carbon (TOC) testing in support of pharmaceutical water system monitoring
Execute validation testing for Endotoxin and TOC methods, including protocol and report authorship
Author Laboratory Investigation Reports (LIRs) for OOS/OOT/deviation events, including root-cause analysis and CAPA input
Prepare Annual Product/Trend Reports for microbiological and analytical data
Write and review Growth Promotion protocols/reports in support of media qualification
Conduct general logbook review to ensure GMP data integrity compliance
Deliver TOC and Endotoxin training as SME, including training junior analysts and cross-functional staff
Support internal and client/regulatory audits as required

Qualifications & Experience

BSc/MSc in Microbiology, Analytical Chemistry, or related life science discipline
4+ years' QC Microbiology/analytical experience within a GMP pharmaceutical or biotech environment
Demonstrated hands-on expertise in Endotoxin (LAL) and TOC testing methodologies
Experience authoring validation protocols/reports for microbiological/analytical methods
Strong background in investigation writing (LIRs/deviations) and CAPA processes
Proven experience as a training SME (TOC and/or Endotoxin)
Working knowledge of EU GMP, FDA guidelines, and USP/EP compendial requirements
Familiarity with LIMS and electronic logbook/documentation systems

Senior QC Microbiologist

Job Description