Specialty Probiotics Australia – Ormeau QLD

The Laboratory Supervisor - Microbiology is responsible for ensuring the integrity, accuracy,

and regulatory compliance of raw materials, in-process samples, and finished products. This

position leads laboratory operations in maintaining method verification, data review, and

compliance activities in alignment with TGA regulations, PIC/S GMP guidelines, and

company SOPs..

Key Responsibilities:

- Assist with establishing all laboratory functions in accordance with GMP and GLP
- Management of samples and coordination of testing done by external laboratories.
- Perform chemical, physical, and microbiological testing of raw materials, in-process samples, and finished probiotic products according to validated methods and specifications.
- Review analytical results, batch records, and laboratory documentation for accuracy and GMP compliance.
- Coordinate and oversee method development, method verification/validation, and stability studies as required.
- Investigate out-of-specification (OOS), out-of-trend (OOT), and non-conformance results, and support root cause analysis and CAPA implementation.
- Support equipment qualification, calibration, and routine maintenance in accordance with GMP and GLP.
- Manage reference and retention samples.
- Prepare, sterilize, and perform quality control checks on culture media for probiotics enumeration and contamination testing.
- Conduct microbial enumeration, contamination testing, and pathogen screening.
- Perform Moisture Content (MC), Water Activity (Aw) testing and other stability related testings to ensure product shelf-life and stability.
- Assist in monitoring the cleanroom/production environment for potential




- Maintain good documentation practices (GDP) and ensure timely data entry and reporting.
- Liaise with QA, Production, and R&D; teams to support product release, investigations, and continuous improvement initiatives.
- Assist in training and mentoring of junior laboratory staff.
- Contribute to internal and external audits, including TGA inspections.

Key Relationships:

- Quality Assurance
- Quality Control
- Manufacturing and Packaging Operations
- Regulatory Affairs
- TGA Inspectors and third-party auditors
- External vendors and service providers

Qualifications & Experience:

- Bachelor’s degree in Microbiology, Chemistry or Biotechnology, or related field.
- Minimum 5 years' experience in a GMP-regulated QC laboratory.
- Strong knowledge of PIC/S Guide to GMP, validation principles, TGA regulations, and Australian regulatory setting for complementary medicines.
- Demonstrated ability to write and review technical and regulatory documents.
- Strong understanding of risk management and quality systems.
- Experience in a complementary medicine or probiotic manufacturing facility.
- High attention to detail and documentation accuracy.
- Strong analytical and problem-solving skills.
- Effective written and verbal communication.
- Ability to manage multiple projects and priorities.
- Leadership and mentoring capabilities.
- Collaborative team player with a proactive mindset.

Performance Measures:

- Compliance with internal SOPs and regulatory requirements.
- Timely completion of validation projects.
- Audit readiness and minimal audit findings.

This role is primarily site-based, operating within GMP laboratory environments. Occasional

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📌 Laboratory Supervisor - Microbiology (City of Gold Coast)
🏢 Specialty Probiotics Australia
📍 City of Gold Coast