
Microbiological Analyst
3 days ago
In this role, you will play a pivotal part in upholding Laboratory Documentation and Data Integrity requirements.
You will be responsible for conducting environmental and microbiological tests as necessary, defining and updating procedures for the plant relative to microbiological and environmental testing, and validating equipment and test methods for microbiological tests.
You will also be involved in the transfer of microbiological methods, developing laboratory procedures, and maintaining detailed records of all tests performed.
Main Responsibilities:
- Maintain and align with Laboratory Documentation and Data Integrity requirements.
- Understand Regulations and business processes required to maintain Laboratory Data Integrity.
- Conduct environmental and microbiological tests as necessary.
- Define and update procedures for the plant relative to microbiological and environmental testing.
- Validate equipment and test methods for microbiological tests.
- Transfer microbiological methods.
- Develop laboratory procedures.
- Maintain detailed records of all tests performed.
Required Skills and Qualifications:
- Bachelor's or master's degree in microbiology or an equivalent science discipline.
- Good knowledge of aseptic process manipulation and experience within a GLP/GMP environment, along with familiarity with current EU/FDA/ICH/HPRA guidelines.
- Laboratory experience within industry – Bioburden / Endotoxin / Growth Promotion / Environmental Monitoring.
- Experience within a sterile cleanroom environment.
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