FQC - Mircrobiologist
Undisclosed
Job Summary: The microbiologist is responsible for performing microbiological testing, environmental monitoring, and sterilization-related quality control activities to ensure medical devices comply w
Job Summary:
The microbiologist is responsible for performing microbiological testing, environmental monitoring, and sterilization-related quality control activities to ensure medical devices comply with established quality specifications, ISO 13485, applicable international standards, and regulatory requirements.
Responsibilities:
1. Manage and conduct microbiology section activity on daily routine analysis including sterility testing, bioburden testing, biological indicator (BI) testing and microbial identification, according to approved procedures.
2. Conduct environmental monitoring of cleanrooms, controlled environments, and microbiology laboratories.
3. Prepare culture media, perform growth promotion testing, and monitor incubation conditions.
4. Operate and maintain microbiology laboratory equipment, including autoclaves, incubators, and biological safety cabinets, where applicable.
5. Conduct microbiological testing related to Ethylene Oxide (EO) sterilization validation and routine monitoring.
6. Review microbiological test results, investigate abnormal findings, and support root cause analysis and CAPA.
7. Maintain accurate laboratory records, trend analysis report and ensure compliance with Good Documentation Practices.
8. Support finished goods inspection, sampling, and quality verification activities when required.
9. Review and revise SOPs, qualification/validation protocols and reports.
10. Participating in quality control and quality assurance activities including proficiency testing, revalidation activities and internal audits.
Qualification & Requirements:
• Diploma or Bachelor's Degree in Microbiology, Biotechnology, Biomedical Science, Medical Laboratory Technology, or a related discipline.
• Experience in microbiological testing, particularly in the medical device or pharmaceutical industry.
• Experience in sterility testing, bioburden testing, environmental monitoring, and aseptic techniques.
• Familiarity with ISO 13485, ISO 11135, ISO 11737-1, and ISO 11737-2.
• Experience with Ethylene Oxide (EO) sterilization and related documentation is an advantage.
• Proficient in quality documentation, data analysis, and report preparation.
• Strong attention to detail, analytical skills, and ability to work independently and cross-functionally.