QC Associate Microbiology Specialist
2 weeks ago
About the Role
In this role, you will provide technical support to the QC Microbiology Laboratory and Operations, ensuring the continued manufacture and supply of high-quality pharmaceutical products. This position involves method validation, equipment validation, troubleshooting, documentation development, and microbiological support across the site. You will also play a key role in driving continuous improvement, training, and regulatory compliance within the microbiology function.
Key Responsibilities
- Develop and execute Microbiology test methods and project validations
- Troubleshoot issues during validation studies and routine microbiology testing
- Provide microbiological support for site investigations
- Drive Continuous Improvement initiatives, including lean lab practices and method optimization
- Author and manage change controls, procedures, test methods, and deviations
- Authorize microbiological test results to support batch release
- Perform LIMS system updates and assess regulatory updates relevant to the microbiology lab
- Support the environmental control program, including trend analysis and CAPA implementation
- Ensure compliance with regulatory, compendial, and company quality standards
- Maintain the highest safety standards in all lab operations
What We're Looking For
- Bachelor's degree or higher in Microbiology or a related discipline
- Minimum 5 years of experience in a pharmaceutical microbiology environment
- Strong knowledge and experience with microbiology test methods (e.g., Bioburden, Endotoxin, and Sterility testing)
- Demonstrated expertise in method validation and development
- Experience in pharmaceutical regulatory compliance and change management
- Excellent problem-solving, leadership, and communication skills
- Ability to work independently while collaborating with cross-functional teams
This is an excellent opportunity to join a dynamic and innovative company where you can make a real impact in quality, compliance, and continuous improvement. If you have a passion for microbiology and pharmaceutical quality, we would love to hear from you
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