Senior QC Microbiologist

Complete Laboratory Solutions; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Complete Laboratory Solutions is seeking a Senior QC Microbiologist to lead routine and non-routine microbiological testing in support of GMP drug substance/product manufacture, with emphasis on endotoxin and TOC testing and environmental monitoring review.

The role carries SME-level responsibility for training delivery and technical review within the QC Microbiology function, including investigation writing and CAPA input, with opportunities to support audits and continuous improvement.

Qualifications

• 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.

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 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.

Skills

Endotoxin (LAL) testing

TOC testing

GMP pharmaceutical/biotech experience

Training SME

Investigation writing

CAPA processes

EU GMP/FDA knowledge

LIMS familiarity

Education

BSc/MSc in Microbiology or related life science

Tools

LIMS

Electronic logbooks

Job description

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