As a QC Microbiology Analyst, you will play a pivotal role in shaping the microbiology operations for our new clinical manufacturing facility in Australia.
Requirements
- Support the qualification and operational readiness of the QC Microbiology Laboratory.
- Develop and implement SOPs, workflows, and quality systems aligned with TGA and PIC/S guidelines.
- Perform QC microbiological testing for cleanrooms, utilities, raw materials, product release, and stability studies.
- Lead method transfer, development, validation activities following ICH Q2(R2), Q14, and compendial requirements.
- Monitor environmental programs through data review, trend analysis, and investigation of excursions.
- Ensure GMP compliance, data integrity (ALCOA+), and adherence to compendial requirements in all operations.
Benefits
- Competitive remuneration packages
- Variety of benefits in support of our diverse employee base