GMP Microbiology Lab Supervisor – Probiotics

Specialty Probiotics Australia; Gold Coast City; Sur place; AUD 90 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Leadership

Regulatory compliance

GMP/GLP

Data review

Documentation

Laboratory operations

Formation

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

Description du poste

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