Senior QC Microbiology Associate – 24/7 Onsite EM

Amgen; Ireland; On-site; EUR 53,000 - 71,000; Full time

Job summary

Amgen seeks a Sr Associate Quality Control to join its Onsite Environmental Monitoring team in a 24/7 shift pattern. The role focuses on environmental monitoring across cleanrooms and requires strong microbiology and aseptic manufacturing expertise.

Key duties include plate reading, bioburden testing, water sampling, and writing EM trend reports. A Bachelor’s in science and regulatory-compliant QC experience are essential, with familiarity in LIMS, Trackwise, SAP, and CDOCS advantageous.

Qualifications

• Bachelor's degree in a science discipline.
• Biopharmaceutical QC experience in a microbiology lab.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Responsibilities

• Environmental Monitoring of Grade 8/9 Cleanrooms.
• Environmental Monitoring of Grade 5/7 Cleanrooms, RABS & Isolators.
• Reading of Environmental Monitoring Plates.
• Bioburden testing of water & disinfectants.
• Writing technical reports such as monthly and annual EM trend reports.
• Water sampling.
• Testing of In Process samples such as pH.
• Testing of Biological Indicators.

Skills

Microbiology

Aseptic manufacturing

Regulatory compliance

Education

Bachelors degree in a science discipline

Biopharmaceutical QC experience in a microbiology lab

Regulatory compliance in cGMP manufacturing

Tools

LIMS

Trackwise

SAP

CDOCS

Job description

Amgen seeks a Sr Associate Quality Control to join its Onsite Environmental Monitoring team in a 24/7 shift pattern. The role focuses on environmental monitoring across cleanrooms and requires strong microbiology and aseptic manufacturing expertise.

Key duties include plate reading, bioburden testing, water sampling, and writing EM trend reports. A Bachelor’s in science and regulatory-compliant QC experience are essential, with familiarity in LIMS, Trackwise, SAP, and CDOCS advantageous.