Microbiology QA Specialist – GMP/ISO 13485

Complete Laboratory Solutions; Galway; On-site; EUR 45,000 - 65,000; Full time

Job summary

Complete Laboratory Solutions in Galway is seeking a Quality Assurance Microbiologist to oversee microbiological quality across manufacturing and laboratory operations in a GMP/ISO 13485 setting.

This role combines quality review with technical support for contamination control, environmental monitoring, sterilisation programmes, bioburden and endotoxin testing, working cross-functionally with Quality, Manufacturing, Validation and Laboratory teams.

Qualifications

• Bachelors degree in Microbiology or related life science discipline.
• Experience in a Microbiology, Quality Assurance, or Quality Control role within regulated industries.

Responsibilities

• Review and approve microbiology test data and records, including bioburdens, endotoxin, sterility, and environmental monitoring results.
• Provide quality oversight to ensure microbiological activities comply with GMP, ISO 13485, and applicable regulatory requirements.
• Support contamination control strategies, including cleanroom and controlled environment monitoring programmes.
• Support sterilisation and microbiological validation activities, including bioburden recovery, sterility assurance, and routine monitoring programmes.
• Lead or support investigations into OOS/OOT results, microbial excursions, deviations, and non-conformances, ensuring root-cause analysis and CAPA.
• Author, review, and approve SOPs, protocols, reports, risk assessments, and other quality documentation.
• Support change control activities by assessing microbiological impact and ensuring appropriate quality oversight.
• Trend microbiological and environmental monitoring data and communicate findings to site quality leadership.
• Participate in internal, customer, and regulatory audits, supporting inspection readiness activities.
• Collaborate with Manufacturing, Quality Control, Quality Engineering, Validation, and Operations teams.
• Identify and support continuous improvement opportunities to enhance compliance, efficiency, and product quality.

Skills

Quality assurance

Microbiology

Data review

Regulatory compliance

Education

Bachelors degree in Microbiology

Job description

Complete Laboratory Solutions in Galway is seeking a Quality Assurance Microbiologist to oversee microbiological quality across manufacturing and laboratory operations in a GMP/ISO 13485 setting.

This role combines quality review with technical support for contamination control, environmental monitoring, sterilisation programmes, bioburden and endotoxin testing, working cross-functionally with Quality, Manufacturing, Validation and Laboratory teams.