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Sr Associate QC - Microbiology

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Amgen

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Location:
Ireland , Dun Laoghaire

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Contract Type:
Not provided

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Salary:

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Job Description:

This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.

Job Responsibility:

  • Environmental Monitoring of Grade 8/9 Cleanrooms
  • Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
  • Reading of Environmental Monitoring Plates
  • Bioburden testing of water & disinfectants
  • Writing technical reports
  • Water sampling
  • Testing of In Process samples such as Density & pH
  • Initiate and/or implement changes in controlled documents
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope
  • Write protocols and perform validation and equipment qualification/verification
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols
  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis
  • Approve lab results

Requirements:

  • 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

Nice to have:

  • Minimum three years' Biopharmaceutical QC experience in a microbiology lab, working as part of an Environmental Monitoring team who directly support manufacturing in a Grade A/B area
  • Proficient in the use of LIMS & LMES
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
  • Experience with Regulatory inspectors and interacting with inspectors desirable

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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