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Microbiologist
2 months ago
We are seeking a highly skilled Microbiologist to join our team at Comrise. As a key member of our Microbiology group, you will be responsible for ensuring the sterility and compliance of our products with relevant regulatory requirements and standards.
Key Responsibilities- Microbial Compliance: Ensure that our products meet the required standards for microbial compliance, including testing, monitoring, and validation of cleaning and sterilization processes.
- Sterility Practices: Oversee and ensure effective and efficient sterility practices, including environmental monitoring of cleanrooms, monitoring of utilities, and bioburden and endotoxin testing.
- Quality Assurance: Lead the generation and resolution of NC and CAPA within the Microbiology group and across related business units.
- Technical Lead: Act as technical lead for microbiology in cross-functional groups, including product and process issues, root causing, projects, initiatives, and other business-critical forums.
- Regulatory Compliance: Ensure compliance with relevant regulatory requirements, including European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements.
- Collaboration: Build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
- Education: Bachelor's degree in Microbiology or a related discipline.
- Experience: 6 years' experience as a Microbiologist in a regulated industry, with strong competency in troubleshooting, correction of NC, and root cause analysis.
