Location: Yatala, QLD
Employment Type: Full-Time
We are seeking an experienced and highly motivated Microbiologist to establish and lead microbiology laboratory operations within a GMP‐regulated environment. This is an exciting opportunity for a skilled microbiology professional to play a key role in laboratory setup, compliance, method development, and quality leadership within a growing pharmaceutical/complementary medicines business.
Key Responsibilities
* Lead and perform microbiological testing of raw materials, finished products, stability samples, water, and environmental monitoring samples in accordance with GMP, TGA, and approved laboratory procedures.
* Review and approve microbiological test results, laboratory records, certificates of analysis, and technical reports.
* Conduct and lead OOS, OOT, deviation, and contamination investigations, including root cause analysis and CAPA implementation.
* Develop, validate, verify, and transfer microbiological methods in accordance with pharmacopoeial and regulatory requirements.
* Establish, commission, and maintain microbiology laboratory operations, including laboratory layout, workflow design, equipment qualification, environmental monitoring programs, and quality systems.
* Ensure compliance with TGA, GMP, data integrity, and laboratory quality requirements.
* Prepare and review SOPs, specifications, protocols, validation reports, risk assessments, and other GMP documentation.
* Provide technical leadership, training, and mentoring to laboratory staff.
* Support regulatory inspections, customer audits, and continuous improvement initiatives.
Qualifications
* Bachelor's degree or higher in Microbiology, Pharmaceutical Sciences, or a related scientific discipline.
* Minimum 3–5 years' experience in a GMP‐regulated pharmaceutical, complementary medicines, or contract testing laboratory.
* Demonstrated experience in laboratory setup, equipment qualification, workflow implementation, and quality system development.
* Proven experience with microbiological method validation, environmental monitoring, contamination control, and investigation management.
* Strong knowledge of TGA, GMP, USP, BP, EP, and data integrity requirements.
* Excellent technical, organisational, and communication skills with the ability to work independently and lead laboratory operations.
* Previous experience establishing or commissioning a new GMP microbiology laboratory.
* Experience supporting TGA audits, client audits, and regulatory inspections.
What We Offer
* Opportunity to play a key role in building and shaping a new GMP microbiology laboratory.
* Collaborative and professional working environment.
* Career growth and leadership opportunities.
If you are a proactive microbiology professional passionate about quality, compliance, and laboratory excellence, we would love to hear from you.
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