About the role
Reporting to the QC Microbiology Lead, the QC Microbiology Scientist will perform advanced microbiological laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes execution and troubleshooting of microbiological testing, environmental monitoring, stability sample handling, equipment operation, method transfers, and documentation in accordance with GMP, corporate quality standards, and regulatory requirements.
What they're looking for
- Perform and review advanced microbiological QC testing for drug products, raw materials, packaging components, and utilities in accordance with approved methods and SOPs
- Lead and execute environmental monitoring, bioburden, endotoxin, microbial limits, microbial identification, and sterility testing
- Provide scientific expertise in troubleshooting, investigations, and technical issue resolution
- Author, review, and revise SOPs, test methods, and technical documents
- Mentor and train QC Analysts and Associates on microbiological methods and best practices
- Other QC tasks assigned by microbiology lead
More about this role
Reporting to the QC Microbiology Lead, the QC Microbiology Scientist will perform advanced microbiological laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes execution and troubleshooting of microbiological testing, environmental monitoring, stability sample handling, equipment operation, method transfers, and documentation in accordance with GMP, corporate quality standards, and regulatory requirements. The QC Microbiology Scientist will support both startup and steady-state operations, ensuring timely and accurate completion of QC tasks for product release, stability studies, validation, and regulatory audits.
- Perform and review advanced microbiological QC testing for drug products, raw materials, packaging components, and utilities in accordance with approved methods and SOPs.
- Lead and execute environmental monitoring, bioburden, endotoxin, microbial limits, microbial identification, and sterility testing.
- Provide scientific expertise in troubleshooting, investigations, and technical issue resolution.
- Author, review, and revise SOPs, test methods, and technical documents.
- Mentor and train QC Analysts...
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