QC Microbiologist

1 week ago

Brisbane, Queensland, Australia Thermo Fisher Scientific Inc. Full time
About the Role

We are seeking a highly skilled and experienced QC Microbiologist to join our team at Thermo Fisher Scientific Inc. As a key member of our Quality Control Microbiology Laboratory, you will play a critical role in ensuring the quality and safety of our biopharmaceutical products.

Key Responsibilities
  • Contribute to the efficient and effective operation of the QC Microbiology Laboratory, ensuring compliance with international quality requirements and regulatory agencies.
  • Perform QC microbiological testing and associated tasks, including bioburden testing of process intermediates, crude harvest, and drug substance, as well as WFI.
  • Conduct environmental monitoring, including surface monitoring, active and passive air sampling, to ensure a safe working environment.
  • Participate in activities related to analytical development and QC test strategy to meet or support client requirements and expectations.
  • Perform growth promotion testing of microbiological media used in testing.
  • Responsible for stock control within the Microbiology laboratory, ensuring accurate and timely inventory management.
  • Perform all work in a safe manner, adhering to EH&S safe working practices, including wearing of personal protective equipment (PPE), and conduct proactive hazard identification and reporting.
  • Actively contribute to process improvement initiatives, preparing, maintaining, and improving the quality of microbiological generated documents, including SOPs, Specifications, Test Methods, Policies, Summary Reports, and Investigation Reports.
  • Initiate and implement Change Controls, actively contributing to raising Change Controls, reporting, and investigating microbiological excursions (OOS, DRs).
  • Provide microbiological technical support and input into Quality-related issues, communicating effectively across departments and internal customers.
  • Perform internal and external networking with other microbiologists and external specialists for benchmarking and development.
  • Document all work to GMP standards, ensuring accurate and complete records.
  • Perform training of QC Microbiology staff and other staff as required, ensuring knowledge transfer and skill development.
  • Contribute to regulatory and client audits when required, ensuring compliance and quality standards.
Requirements
  • Tertiary Science qualification (either degree in a related science field or post-secondary education in an appropriate field) with experience in laboratory testing, good aseptic technique, and validation required for the bio-pharmaceutical industry.
  • Experience of working in a manufacturing or laboratory environment with knowledge of bio-pharmaceutical processes and pharmaceutical guidelines preferred.
  • Background in Microbiology, familiarity with principles of aseptic techniques, and microbiological testing preferred.
  • Knowledge of GLP, cGMP, and Quality Principles.
  • Proven record of ability to work as a team member and independently as required.
  • Experience in multitasking, prioritizing, and showing initiative to complete tasks according to company milestones.
  • A track record showing good oral and written communication skills.
  • Computer literate in word processing, spreadsheets, and databases.
  • Adaptability: Ability to adapt to daily business requirements.
  • Collaborating: Ability to work with all departments and colleagues of varied backgrounds.
  • Continuous Improvement: Drive PPI.
  • Quality Orientation: Ability to interpret and apply cGMP principles, strong attention to detail, and accurate completion of test records.
  • Deliver the best technical and scientific solutions to improve product value.
  • Build a culture of engagement, accountability, and a shared commitment to excellence.
  • Abide by all EH&S policies and procedures, operate our business in a safe, focused, responsible, and ethical fashion.

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