Senior QC Microbiologist – GMP Endotoxin & TOC Specialist

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

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.