Senior Microbiology QC Specialist (24/7 Onsite)

Amgen; Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

Amgen is seeking a Sr Associate Quality Control to support manufacturing operations with a 24/9 shift pattern onsite in Ireland. The role focuses on environmental monitoring of cleanrooms (Grade 8/9 and 5/7), bioburden testing, and writing EM trend reports, with flexibility for extended hours.

The candidate should have a strong microbiology background, experience with LIMS/SAP/Trackwise, and the ability to work independently while ensuring right-first-time results in a regulated environment.

Qualifications

• Bachelors 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 interaction

Problem solving

Leadership

Communication

Education

Bachelor's degree in a science discipline

Tools

LIMS

Change Control

Trackwise

SAP

CDOCS

Job description

Amgen is seeking a Sr Associate Quality Control to support manufacturing operations with a 24/9 shift pattern onsite in Ireland. The role focuses on environmental monitoring of cleanrooms (Grade 8/9 and 5/7), bioburden testing, and writing EM trend reports, with flexibility for extended hours.

The candidate should have a strong microbiology background, experience with LIMS/SAP/Trackwise, and the ability to work independently while ensuring right-first-time results in a regulated environment.