Senior QC Microbiology Associate — 24/7 Environmental Monitoring

Amgen Inc.; Dublin; Presencial; EUR 53.000 - 71.000; Jornada completa

Descripción de la vacante

Amgen Inc. is seeking a Sr Associate Quality Control to support manufacturing operations in a 24/7 onsite role. The candidate will handle environmental monitoring of multiple cleanroom grades, perform bioburden testing, and generate EM trend reports as part of a regulated cGMP environment.

The role requires a strong microbiology background, experience with LIMS, Trackwise, SAP, and CDOCS, and the ability to work independently with minimal direction while maintaining quality and safety standards.

Formación

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

Responsabilidades

• 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

Conocimientos

Microbiology

Aseptic manufacturing

Regulatory liaison

Educación

Bachelors degree in science

Herramientas

LIMS

Trackwise

SAP

CDOCS

Descripción del empleo

Amgen Inc. is seeking a Sr Associate Quality Control to support manufacturing operations in a 24/7 onsite role. The candidate will handle environmental monitoring of multiple cleanroom grades, perform bioburden testing, and generate EM trend reports as part of a regulated cGMP environment.

The role requires a strong microbiology background, experience with LIMS, Trackwise, SAP, and CDOCS, and the ability to work independently with minimal direction while maintaining quality and safety standards.