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Quality Control Specialist – QC Microbiology (11‑month contract)

RECRUITERS · Carlow

New
Contract Onsite Mid 🇬🇧 English
Environmental Monitoring Aseptic Processing Contamination Control Data Trending Risk Assessment Validation Studies Data Analysis Electronic Laboratory Systems

Job description

About the role

We are seeking a motivated Quality Control Specialist to join a high‑performing QC Microbiology team within a regulated pharmaceutical manufacturing environment. The role will support microbiology operations, ensure GMP compliance and drive continuous improvement initiatives.

Key responsibilities

  • Support the Environmental Monitoring program through data trending, analysis and CAPA implementation.
  • Own and conduct Environmental Monitoring risk assessments and qualification activities.
  • Generate quarterly and annual trend reports for microbiology operations.
  • Develop and execute microbiology test methods and validation studies.
  • Troubleshoot issues arising during routine testing and validation.
  • Provide microbiology support for site investigations, environmental and utilities monitoring projects.
  • Lead continuous improvement projects, including Lean Lab initiatives and method optimisation.
  • Author and manage SOPs, change controls, deviations and controlled documentation in line with GMP.
  • Review and authorize microbiological results to support batch release.
  • Ensure compliance with regulatory requirements, ALCOA(+) data integrity and company quality standards.

Required profile

  • Bachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science or related life‑science field.
  • Minimum 3 years experience in a GMP QC Microbiology laboratory.
  • Strong knowledge of environmental monitoring, aseptic processing and contamination control.
  • Experience with data trending, risk assessments, validation studies and data analysis.
  • Ability to author SOPs, change controls, deviations and other quality documentation.
  • Familiarity with regulatory requirements, ALCOA(+) data integrity principles and electronic laboratory systems.

Required skills

  • Environmental Monitoring
  • Aseptic Processing
  • Contamination Control
  • Data Trending
  • Risk Assessment
  • Validation Studies
  • Data Analysis
  • SOP Authoring
  • Change Control Management
  • Deviation Management
  • Electronic Laboratory Systems
  • GMP Compliance

Questions fréquentes

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Le contrat proposé est un Contract basé à Carlow.

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Published 4 days ago

Expires 1 month from now

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RECRUITERS

Carlow