GMP Quality Control Specialist – RNA Therapeutics

Aurora Biosynthetics; Sydney; On-site; AUD 90,000 - 110,000; Full time

Job summary

Aurora Biosynthetics Pty Ltd is seeking a QC Specialist to ensure GMP-compliant quality control of incoming materials, utilities, and processes. The role focuses on qualification, inspection, sampling, testing, and verification to support compliant manufacturing and product release.

The candidate will contribute to data integrity and regulatory compliance while supporting continuous improvement. The position involves microbiology, environmental monitoring, sterility assurance, analytical

Qualifications

• GMP compliance knowledge and data integrity principles.
• Strong technical documentation skills and GMP records.
• Experience with quality control activities: sampling, testing, release.
• Ability to work across Quality, Manufacturing, Warehouse, and Supply Chain.

Responsibilities

• Conduct criticality assessments of incoming materials and packaging components.
• Develop QC specifications, sampling plans, and acceptance criteria.
• Perform sampling, inspection, testing, verification, and disposition support.
• Monitor quality of critical utility systems via sampling and testing.
• Support supplier qualification and performance monitoring activities.
• Ensure warehouse quality and GMP compliance; support investigations and CAPAs.
• Provide microbiological, environmental monitoring, sterility assurance and analytical testing support.
• Support stability and retention sample programs and GMP records.

Skills

GMP knowledge

Data integrity

Documentation accuracy

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree in microbiology/biotechnology/biochemistry/related field

Job description

Aurora Biosynthetics Pty Ltd is seeking a QC Specialist to ensure GMP-compliant quality control of incoming materials, utilities, and processes. The role focuses on qualification, inspection, sampling, testing, and verification to support compliant manufacturing and product release.

The candidate will contribute to data integrity and regulatory compliance while supporting continuous improvement. The position involves microbiology, environmental monitoring, sterility assurance, analytical