Microbiology QC Associate — Environmental Monitoring & Continuous Improvement

Aphex Group; Carlow; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Aphex Group in Ireland is seeking an Associate Specialist Quality Control to provide technical support to the QC Microbiology Lab and operations. You will ensure quality pharmaceutical products meet compliance, supply, strategy, and profitability goals, while leading continuous improvement and coaching teams.

You will develop microbiology methods, support environmental monitoring programs, and manage change controls, deviations, and documentation to maintain regulatory compliance and product

Qualifikationen

• Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or related Life Sciences field is required.
• Minimum 3 years hands-on experience in microbiology/QC, environmental monitoring, utilities monitoring, trending, risk assessments, and data analysis.

Aufgaben

• Support environmental control program through trend analysis and corrective/preventive actions.
• Own environmental monitoring risk assessments and qualification activities.
• Generate quarterly and annual trend reports.
• Apply regulatory/compliance and compendial requirements in daily work.
• Develop and validate microbiology test methods and project validations.
• Troubleshoot issues during validation studies and routine tests.
• Develop training modules for the team.
• Support site investigations related to environmental monitoring and utilities monitoring.
• Drive continuous improvement initiatives, incl. lean lab ideas and method optimization.
• Author and manage change controls, procedures, test methods, and deviations.
• Approve results for microbiological samples to support batch release.
• Assist with GLIMS system updates and documentation.
• Ensure adherence to ALCOA(+) data integrity principles.
• Handle routine tasks with growing technical competence.

Kenntnisse

GMP QC

Environmental monitoring

Data analysis

Trend analysis

Regulatory compliance

Change controls

Microbiology methods

Ausbildung

Bachelor's degree in Microbiology

Tools

Electronic laboratory systems

Jobbeschreibung

Aphex Group in Ireland is seeking an Associate Specialist Quality Control to provide technical support to the QC Microbiology Lab and operations. You will ensure quality pharmaceutical products meet compliance, supply, strategy, and profitability goals, while leading continuous improvement and coaching teams.

You will develop microbiology methods, support environmental monitoring programs, and manage change controls, deviations, and documentation to maintain regulatory compliance and product