GMP Microbiology QC Specialist

Mavlab Pty Ltd; Brisbane; Presencial; AUD 70 000 - 90 000; Tempo integral

Resumo da oferta

Mavlab Animal Health is seeking a Quality Control Microbiologist at our Logan City site to perform microbiological testing and support release of materials. You will work closely with Production, QA and Warehouse to ensure timely, compliant product release.

Responsibilities include environmental monitoring, troubleshooting, deviations and CAPA, documentation, and collaboration with cross-functional teams to uphold GMP and regulatory standards in a regulated manufacturing environment.

Qualificações

• Degree in Science, Chemistry, Pharmacy or related discipline required or equivalent industry experience.
• Prior QC experience in pharmaceutical, veterinary, food or GMP-regulated manufacturing preferred.
• Working knowledge of GMP, TGA and/or APVMA requirements or willingness to learn.
• Hands-on laboratory testing experience.
• High attention to detail and accurate documentation practices.
• Good communication skills and ability to work in cross-functional teams.
• Proactive problem-solving mindset and commitment to quality and continuous improvement.

Responsabilidades

• Perform microbiological testing of raw materials, in-process samples, water and finished products (bioburden, sterility, endotoxin, microbial enumeration, specified organisms, preservative efficacy).
• Run environmental monitoring program for cleanrooms (viable, non-viable, personnel monitoring) with trending and reporting.
• Monitor sampling and testing of WFI system with trend analyses.
• Design, perform and report surface and disinfectant challenge studies; support cleaning and disinfection programs.
• Carry out line clearances in production area; assess hygiene and microbial risk.
• Review batch records and microbiological data to support batch release decisions.
• Raise and investigate deviations, OOS/OOT results and excursions; drive root cause analysis and CAPA.
• Raise, assess and support change controls for microbiological impact.
• Write and review SOPs, protocols and reports; support method verification and validation activities.
• Receive, verify and perform growth promotion and sterility checks on culture media; maintain reference strains.
• Manage laboratory consumables and reagents; stock control and supplier documentation.
• Ensure all laboratory equipment is calibrated, qualified and maintained; coordinate external calibration.
• Maintain laboratory’s microbial reference cultures; passage control and storage.
• Ensure cleaning and hygienic maintenance of microbiology laboratory.
• Support internal audits including regulatory and client audits.

Conhecimentos

Attention to detail

Documentation

Communication

Cross-functional teamwork

Problem solving

Formação académica

Science/chemistry/pharmacy degree

Ferramentas

Incubators

Autoclaves

Biosafety cabinets

Balances

Culture media

Refrigerators

Descrição da oferta de emprego

Mavlab Animal Health is seeking a Quality Control Microbiologist at our Logan City site to perform microbiological testing and support release of materials. You will work closely with Production, QA and Warehouse to ensure timely, compliant product release.

Responsibilities include environmental monitoring, troubleshooting, deviations and CAPA, documentation, and collaboration with cross-functional teams to uphold GMP and regulatory standards in a regulated manufacturing environment.