Associate Microbiology QC Specialist

Aphex Group; Carlow; On-site; EUR 45,000 - 65,000; Full time

Job summary

Aphex Group in Ireland is seeking an Associate Specialist Quality Control to provide scientific oversight in the QC Microbiology Lab and support operations to ensure compliant pharmaceutical production.

The role focuses on environmental monitoring, trend analysis, risk assessment, and method validations, with emphasis on regulatory alignment and continuous improvement. You will author procedures and change controls, and contribute to batch release through microbial testing and data integrity.

Qualifications

• Minimum 3 years hands-on experience in microbiology/QC, environmental monitoring and utilities monitoring, supporting site projects, trending, risk assessments, and data analysis.
• Ability to author procedures, change controls, deviations, reports, and work in line with regulatory/compendial requirements.
• Strong understanding of aseptic processing and contamination control in sterile manufacturing.
• Experience in a GMP QC laboratory with knowledge of regulatory expectations.

Responsibilities

• Supporting the environmental control program by trend analysis and implementation of corrective/preventive measures.
• Owner of Environmental monitoring risk assessments and qualification.
• Generation of quarterly and annual trend reports.
• Development and execution of Microbiology test methods and project validations.
• Troubleshooting issues during validation studies and routine tests.
• Authoring and managing change controls, procedures, test methods and deviations.
• Result authorization for microbiological samples to support batch release.

Skills

Troubleshooting

Decision making

Lean lab

Method optimization

Education

Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or related Life Sciences

Job description

Aphex Group in Ireland is seeking an Associate Specialist Quality Control to provide scientific oversight in the QC Microbiology Lab and support operations to ensure compliant pharmaceutical production.

The role focuses on environmental monitoring, trend analysis, risk assessment, and method validations, with emphasis on regulatory alignment and continuous improvement. You will author procedures and change controls, and contribute to batch release through microbial testing and data integrity.