Quality Control Microbiologist

Independent Solutions; Leinster; On-site; EUR 65,000 - 80,000; Full time

Job summary

Independent Solutions seeks an Associate Specialist - Quality Control (QC Microbiology) to support GMP-regulated pharmaceutical manufacturing, environmental monitoring and microbiological quality activities.

The role emphasizes trending, data analysis, method development, and change-control execution, with batch-release support and a focus on regulatory compliance and ALCOA(+) data integrity. Applicants should have a related Life Sciences degree and 3–5 years of QC Microbiology experience.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biotechnology or related Life Sciences.
• 3–5 years of hands-on QC Microbiology in environmental and utilities monitoring.
• Experience in GMP QC laboratory and data integrity.
• Strong understanding of aseptic processing and contamination control.
• Experience authoring procedures, deviations and change controls.
• Knowledge of ALCOA(+) principles and controlled documentation.

Responsibilities

• Support environmental and utilities monitoring programmes, including trending and risk assessments.
• Prepare quarterly and annual trend reports.
• Develop and validate microbiology test methods.
• Troubleshoot issues during routine testing and validation.
• Support investigations and change controls, procedures and deviations.
• Drive continuous improvement and lean laboratory initiatives.
• Support microbiological result authorisation for batch release.
• Ensure compliance with regulatory, compendial and data integrity requirements.
• Assist with training, stock management and GLIMS system updates.

Skills

Environmental monitoring

Data analysis

Trend reporting

Aseptic processing

GMP QC

Education

Bachelor's degree in Microbiology or Life Sciences

Tools

GLIMS

Job description

Hiring: Associate Specialist - Quality Control (QC Microbiology)

We are seeking an experienced QC Microbiology professional to support laboratory operations, environmental monitoring and microbiological quality activities within a GMP-regulated pharmaceutical manufacturing environment.

Key Responsibilities

• Support environmental and utilities monitoring programmes, including trending, risk assessments and qualification.
• Prepare quarterly and annual trend reports.
• Develop and execute microbiology test methods and validation studies.
• Troubleshoot issues arising during routine testing and validation.
• Support site investigations and projects involving environmental and utilities monitoring.
• Author and manage change controls, procedures, test methods and deviations.
• Drive continuous improvement, lean laboratory initiatives and method optimisation.
• Support microbiological result authorisation for batch release.
• Maintain compliance with regulatory, compendial and data integrity requirements.
• Support training, laboratory stock management and GLIMS system updates.

Qualifications - Required

• Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science or a related Life Sciences discipline.
• Minimum 3-5 years of hands-on QC Microbiology experience, particularly in environmental monitoring, utilities monitoring, trending, risk assessments and data analysis.
• Experience working in a GMP QC laboratory.
• Strong understanding of aseptic processing, environmental monitoring and contamination control in sterile manufacturing.
• Experience authoring procedures, change controls, deviations and technical reports.
• Knowledge of regulatory and compendial requirements, ALCOA(+) principles and controlled documentation.
• Strong troubleshooting, analytical and decision-making skills.

Preferred Qualifications

• Experience in problem-solving and laboratory process improvement.
• Experience scheduling laboratory testing and coordinating tasks.
• Exposure to lean laboratory initiatives and microbiology method optimisation.
• Familiarity with electronic laboratory systems, including GLIMS.