Microbiologist
On-site · Chengdu, Sichuan, China
Job Summary
The role focuses on leading lab test activities to ensure GLP/GMP-compliant microbiology and related testing for Cochlear’s Chengdu manufacturing site. Responsibilities include performing chemical and microbial tests (sterility, bioburden, particulates) per site monitoring plans, handling decontamination of returned implants, managing reagents and consumables, ensuring timely reporting of out-of-spec results, and executing CAPA with stakeholders. The role also covers production support for microbial control in manufacturing areas (including cleanrooms), documentation to quality systems, internal and external audits, regulatory compliance, incident reporting under WHS, staff training for microbiological controls, and contributing to environmental and microbial control processes to ensure device safety and efficacy. The candidate will work closely with production management, contract laboratories, and cross-functional teams to maintain compliance with evolving regulatory and industry standards and to support continuous improvement initiatives.
Required Qualifications
- Laboratory microbiology testing experience
- Knowledge of GLP and GMP environments
- Ability to perform chemical and microbial tests (sterility, bioburden, particulates)
- Experience with laboratory documentation and data integrity
- CAPA implementation and deviation handling
- Experience with environmental and process monitoring in manufacturing
- Ability to train production personnel on microbiological controls
- Experience in supplier/contract labs and internal compliance audits
- Knowledge of regulatory and industry standards for medical devices/microbiology
- Ability to coordinate external testing and inter-lab communications
- Strong problem-solving with corrective/preventive actions
- WHS and safety procedure adherence
- Decontamination logistics for implanted devices
- Ability to prepare plans, protocols, and reports
- Understanding of GMP documentation requirements
- Ability to handle NCRs and change controls
- Fluency in English and Chinese is a plus
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