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Quality Assurance Professional

2 weeks ago

Melbourne, Victoria, Australia beBeeMicrobiologist Full time $90,000 - $140,000
Senior QC Microbiologist Role

This is an opportunity to take your microbiology expertise to the next level in a cutting-edge biomedical manufacturing environment.

We are seeking a Senior QC Microbiologist to play a critical role in shaping the foundation of a purpose-built clinical manufacturing site.

About the Opportunity

The selected candidate will be responsible for developing and overseeing the Environmental Monitoring (EM) program, managing sampling, testing, and release of raw materials and utilities, interpreting test data, identifying trends, and leading investigations into excursions or deviations.

Key Responsibilities:
  • Develop microbiological SOPs, validation protocols, and quality documentation
  • Support cleanroom qualification, aseptic practices, and contamination risk mitigation strategies
  • Provide subject matter expertise to stakeholders and regulatory bodies during inspections and audits
  • Lead and support continuous improvement in microbiological quality processes
Requirements

To succeed in this role, the ideal candidate will possess a Bachelor's degree in Microbiology, 5+ years' experience in a QC Microbiology role within a regulated cGMP environment, strong knowledge of microbiological testing methods, cleanroom EM practices, and raw material/utility release, hands-on experience in method development, deviation investigations, and technical training, excellent interpersonal and communication skills, with a collaborative and proactive mindset.

Additionally, the successful candidate will have proven ability to manage documentation, risk assessments, and regulatory compliance (TGA/FDA/ISO).

About You
  • Bachelor's degree in Microbiology (postgrad a plus)
  • Strong knowledge of microbiological testing methods and cleanroom EM practices
  • Hands-on experience in method development, deviation investigations, and technical training
  • Excellent interpersonal and communication skills, with a collaborative and proactive mindset
  • Proven ability to manage documentation, risk assessments, and regulatory compliance (TGA/FDA/ISO)