Quality Control Microbiologist

Independent Solutions; Leinster; On-site; EUR 45,000 - 65,000; Full time

Job summary

Independent Solutions is seeking an Associate Specialist - Quality Control (QC Microbiology) to support GMP-regulated laboratory operations, environmental monitoring and microbiological quality activities. The role emphasizes trend analysis, method development and change control management in a pharmaceutical setting.

The successful candidate will have 3–5 years of hands-on QC Microbiology experience, strong knowledge of aseptic processing and data interpretation, and will contribute to

Qualifications

• 3–5 years hands-on QC Microbiology experience.
• GMP QC laboratory experience.
• Experience with environmental and utilities monitoring.
• ALCOA(+) documentation and controlled records.
• Proven ability to write procedures, deviations and change controls.

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 during routine testing and validation.
• Author and manage change controls, procedures, test methods and deviations.
• Support training, laboratory stock management and GLIMS system updates.

Skills

Environmental monitoring

Data analysis

Aseptic processing

Change controls

Troubleshooting

Regulatory knowledge

Education

Bachelor's degree in Microbiology

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.
• If you have relevant QC Microbiology experience and are interested in a contract opportunity in Carlow,