Role Summary:
Our organization is seeking a skilled QC Micro Analyst to oversee laboratory documentation and data integrity processes.
This individual will be responsible for maintaining alignment with regulatory requirements and ensuring the accuracy of laboratory systems. The role also entails conducting environmental and microbiological tests as needed, developing procedures for microbiological and environmental testing, and validating equipment and test methods.
The ideal candidate should possess a third-level qualification in microbiology or an equivalent science discipline. They must have experience working within a GLP/GMP environment and be well-versed in current EU/ FDA/ICH/HPRA guidelines.
Responsibilities:
* Ensure compliance with laboratory data integrity standards
* Conduct environmental and microbiological tests as required
* Develop and maintain microbiological laboratory procedures
* Validate equipment and test methods for microbiological tests
* Transfer test methods for microbiological testing
Qualifications:
* Third level qualification in microbiology or equivalent science discipline
* Experience working in a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines
* Lab experience within industry – Bioburden / Endotoxin / Growth Promotion / Environmental Monitoring
* Experience working in a sterile cleanroom environment
Key Skills:
* Strong knowledge of microbiology and laboratory practices
* Excellent analytical and problem-solving skills
* Ability to work independently and as part of a team
* Effective communication and record-keeping skills