QA Compliance Microbiologist

Health Innovation Research Alliance Northern Ireland; Ireland; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading healthcare organization in Ireland is seeking a QA Compliance Microbiologist to provide quality oversight within cleanroom environments. The successful candidate will conduct inspections, ensure compliance with regulatory standards, and support training initiatives. Candidates should possess a degree in biological science or engineering and have at least 2 years of experience in a high-grade cleanroom environment. This role requires excellent attention to detail and strong communication skills, with flexibility for shift work.

Qualifications

• Educated to at least Degree level or equivalent in a biological science or engineering field.
• Minimum 2 years’ experience within a high-grade cleanroom environment.

Responsibilities

• Provide quality oversight in cleanroom behaviours, gowning, and aseptic techniques.
• Conduct regular inspections and assess compliance with GMP requirements.
• Initiate and support remediation measures in response to inspection findings.
• Deliver training and re-training for personnel in cleanroom protocols.

Skills

Attention to detail

Organisational skills

Computer skills (Microsoft Office)

Communication skills (oral and written)

Flexibility (shift work)

Education

Degree in biological science or engineering

2 years' experience in a high-grade cleanroom environment

Job description

We are currently recruiting for the role of QA Compliance Microbiologist within the QA Cleanroom Compliance department. The successful candidate will provide quality oversight to ensure adherence to all aspects of cleanroom behaviours, gowning, aseptic technique, cleaning & disinfection, transfer procedures and facility standards for classified cleanrooms in line with regulatory requirements. The successful candidate will also support with training, evaluation and continuous improvement projects within our aseptic cleanrooms.

Main Activities/Tasks

Work closely with cleanroom team to ensure alignment with best aseptic practices, standard operating procedures and GMP requirements.

Participating in regular cleanroom inspections to promote continuous improvement and compliance.

Quickly identifying and documenting all deficiencies found during cleanroom inspections and support with assessing risk to product.

Initiating and supporting remediation measures and investigations required in response to the cleanroom inspections finding and environmental monitoring trends.

Arrange & deliver initial training for personnel working in the classified cleanroom environment.

Arrange & deliver periodic re-training in line with SOP & regulatory requirements and/or in response to environmental monitoring trends.

Assisting in the reviewing and compilation of Standard Operation Procedures and other technical documentation in line with current GMP and regulatory requirements.

Support with the selection and validation of new cleanroom cleaning, disinfectant, cleanroom consumable products e.g., mops, wipes, garments, stationary.

Provide technical support for new and upgraded classified cleanroom facilities and cleanroom equipment.

Support simplification & efficiency initiatives.

Participate in customer and regulatory audits.

Be flexible to take any other duties as required by Management.

Applicants must therefore demonstrate the following essential criteria on their application form be considered:

Educated to at least Degree level or equivalent in a biological science or engineering field or have minimum 2 years’ experience within a high-grade cleanroom environment.

Excellent attention to detail and highly organised.

Strong computer skills and proficient in the use of Microsoft Office with the ability to generate reports.

Flexibility to work a shift pattern which may incorporate nights and/or weekends.

Excellent oral and written communication skills.