Senior QC Microbiologist – Endotoxin & TOC Specialist (GMP)

CLS - Complete Laboratory Solutions; Dublin; On-site; EUR 60,000 - 85,000; Full time

Job summary

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

The role carries SME-level responsibility for training delivery and technical review within the QC Microbiology function, including investigation writing and CAPA input.

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.
• Hands-on expertise in Endotoxin (LAL) and TOC testing methodologies.
• Experience authoring validation protocols/reports for microbiological/analytical methods.

Responsibilities

• Perform and review Environmental Monitoring (EM) data in line with site procedures and GMP requirements.
• Conduct and review Endotoxin (LAL) testing across materials, processes and water 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, with root-cause analysis and CAPA input.
• Prepare Annual Product/Trend Reports for microbiological and analytical data.
• 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 testing

TOC testing

GMP

Environmental Monitoring

LIRs / deviations

CAPA processes

Training SME

LIMS

Investigation writing

FDA/USP familiarity

Education

BSc/MSc in Microbiology or Analytical Chemistry

Tools

LIMS

Electronic logbook

Job description

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

The role carries SME-level responsibility for training delivery and technical review within the QC Microbiology function, including investigation writing and CAPA input.