Quality Assurance Specialist

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

Quality Assurance Specialist - Microbiology

Overview

CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dedicated, solutions driven team members with a flexible approach, who want to be part of the company’s continued success.

Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland, providing industry-leading sampling and analysis, and fully trained micro and analytical analysts on contract to clients in the food, environmental, medical device, biopharmaceutical, and pharmaceutical sectors.

We offer bespoke managed service solutions that give clients the option of having our expert team on-site at their own facility or outsourcing those services to us here at CLS.

The Role

CLS is seeking a Quality Assurance Microbiologist to join a leading medical device manufacturing environment in Galway. The successful candidate will provide microbiological quality oversight across manufacturing and laboratory operations within a GMP and ISO 13485 regulated setting. This role combines quality review and approval responsibilities with technical support for contamination control, environmental monitoring, sterilisation programmes, and product bioburden and endotoxin testing. The position offers an excellent opportunity to work cross-functionally with Quality, Manufacturing, Validation, and Laboratory teams while supporting compliance, quality excellence, and continuous improvement initiatives.

Key Responsibilities

Review and approve microbiology test data and records, including bioburden, 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 effective root cause analysis and CAPA implementation.

• 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 closely with Manufacturing, Quality Control, Quality Engineering, Validation, and Operations teams.

• Identify and support continuous improvement opportunities to enhance compliance, efficiency, and product quality.

Who you are

• A quality-focused microbiology professional with a strong understanding of regulated manufacturing environments.

• Detail-oriented with excellent analytical, data review, and problem-solving skills.

• Comfortable working independently while effectively collaborating within cross-functional teams.

• A strong communicator with the ability to influence stakeholders and present technical information clearly.

• Committed to maintaining the highest standards of quality, compliance, and data integrity.

• Motivated by continuous improvement and driving best practices across microbiological quality systems.

Requirements

• Bachelor’s degree in Microbiology, Biological Sciences, Biotechnology, or a related life science discipline.

• Experience in a Microbiology, Quality Assurance, or Quality Control role within the medical device, pharmaceutical, biotechnology, or other regulated industries.

Diversity, Equity & Inclusion

Complete Laboratory Solutions (CLS) is committed to creating a diverse, inclusive, and equal workplace where everyone is treated with respect and given the opportunity to succeed. We are proud to be an Equal Opportunities Employer and welcome applications from all qualified candidates regardless of background, gender, age, disability, ethnicity, religion, sexual orientation, or any other protected characteristic.