Laboratory Supervisor - Microbiology

Specialty Probiotics Australia

Gold Coast City

On-site

AUD 90,000 - 130,000

Full time

3 days ago
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Job summary

Specialty Probiotics Australia in Ormeau, QLD, is seeking a Laboratory Supervisor - Microbiology to lead GMP/QC activities for raw materials, in-process samples, and finished probiotic products. You will ensure regulatory compliance with PIC/S GMP and TGA guidelines while guiding method verification, data review, and CAPA efforts.

The role involves supervising testing, coordinating external labs, and mentoring junior staff to uphold GDP and accurate documentation in a site-based GMP lab

Qualifications

  • 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, TGA regulations, and Australian regulatory environment for complementary medicines.
  • Demonstrated ability to write and review technical and regulatory documents.
  • Strong analytical and problem-solving skills with high attention to detail.
  • Experience in a complementary medicine or probiotic manufacturing facility.

Responsibilities

  • Establish laboratory functions in accordance with GMP and GLP.
  • Manage samples and coordination of testing done by external laboratories.
  • Perform chemical, physical, and microbiological testing of materials and 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, verification/validation, and stability studies as required.
  • Investigate OOS, OOT, and non-conformance results, and support 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 issues.
  • Maintain GDP documentation 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.

Skills

Leadership
Regulatory compliance
GMP/GLP
Data review
Documentation
Laboratory operations

Education

Bachelor’s degree in Microbiology, Chemistry or Biotechnology, or related field

Job description

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 environment 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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