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Microbiological Quality Assurance Specialist

2 weeks ago

Cork, Cork, Ireland Complete Laboratory Solutions Full time

Company Overview

At Complete Laboratory Solutions, we are Ireland's most highly accredited contract laboratory, providing industry-leading sampling, analysis, and skilled micro and analytical analysts on contract to clients across various sectors.

We deliver customized managed service solutions, allowing clients to have our expert team on-site at their own facilities or outsource those services to us here at CLS.

This is a key role within the microbiology team, supporting site operations by ensuring compliance with microbiological quality and regulatory standards.

The role is not a bench-based position but is focused on quality assurance and oversight activities.

Job Description

We are seeking an experienced Senior Microbiologist to join our team in a permanent capacity. This individual will provide microbiological guidance and site direction on quality and compliance issues.

The successful candidate will support laboratory investigations (LIR) and assess microbiological trends, including endotoxin results.

They will oversee the Contamination Control Strategy (CCS) and ensure its effective implementation.

The ideal candidate will lead or contribute to microbiological investigations, including root cause analysis and CAPA development.

They will also provide support during audits, including preparation for an expected HPRA audit.

Collaboration with cross-functional teams is essential to ensure microbiological compliance in manufacturing operations.

Required Skills and Qualifications

  • Bachelor's degree in Microbiology or a related scientific discipline
  • Proven experience in a microbiology role within a pharmaceutical or medical device environment
  • Strong understanding of CCS, laboratory investigations, and contamination control principles
  • Experience in providing microbiological oversight and direction to manufacturing operations
  • Knowledge of regulatory requirements, including HPRA and EU GMP standards

Benefits

A dynamic and collaborative work environment.

Opportunities for professional development and career progression.

Exposure to regulatory audits and compliance strategies.

Competitive salary and benefits package.