Quality Control Specialist

Aurora Biosynthetics; Sydney; Presencial; AUD 90.000 - 110.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GMP knowledge

Data integrity

Documentation accuracy

Cross-functional collaboration

Attention to detail

Educación

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

Descripción del empleo

Company Overview

Aurora Biosynthetics Pty Ltd is a biotechnology company focused on end-to-end RNA

manufacturing solutions, integrating process and analytical development, GMP

manufacturing, quality control, formulation, and fill-finish capabilities to support the

development and production of advanced RNA-based therapeutics.

Role Summary

The QC Specialist is responsible for ensuring that incoming materials, critical utilities,

and quality control activities at Aurora Biosynthetics comply with GMP, regulatory, and

company quality requirements. The role focuses on the qualification, inspection,

sampling, testing, and verification of raw materials, packaging components, and utility

systems to support compliant manufacturing operations and quality disposition of

materials. In addition, the QC Specialist provides support across microbiology,

environmental monitoring, sterility assurance, analytical testing, stability programs,

and contamination control activities. Working within the Pharmaceutical Quality

Systems (PQS), the position plays a key role in maintaining product quality, data

integrity, regulatory compliance, and continuous improvement while contributing to the

timely disposition and release of materials and products and upholding the highest

standards of patient safety.

Responsibilities

• Conduct criticality assessments of incoming materials and packaging components to determine appropriate quality controls, inspection, and testing requirements.
• Develop, maintain, and implement QC specifications, sampling plans, and acceptance criteria for incoming materials in line with GMP, regulatory, and operational requirements.
• Perform sampling, inspection, testing, verification, and disposition support for raw materials, packaging components, and critical utilities.
• Monitor the quality of critical utility systems (e.g., water, compressed air, and process gases) through routine sampling, testing, trending, and reporting of results.
• Support supplier qualification and performance monitoring activities, including review of supplier quality documentation and participation in quality assessments.
• Ensure warehouse quality and GMP compliance from a quality control perspective, maintain accurate QC documentation, and support investigations, deviations, CAPAs, audits, and continuous improvement initiatives as required.
• Provide microbiological, environmental monitoring, sterility assurance, contamination control, and analytical testing support to ensure compliant manufacturing operations and product quality.
• Support stability and retention sample programs, including protocol execution, sample management, data trending, reporting, and maintenance of GMP compliant records to support product lifecycle management and regulatory requirements.

Qualifications & Experience

• Bachelor’s degree in microbiology, biotechnology, biochemistry, chemistry, pharmaceutical sciences, biological sciences, or a related discipline.
• Experience working in a GMP-regulated pharmaceutical, biotechnology, biologics, advanced therapeutics, cell and gene therapy, medical device, or related life sciences environment.
• Experience performing quality control activities such as sampling, testing, inspection, material release, or laboratory operations.
• Sound understanding of GMP requirements, Pharmaceutical Quality Systems (PQS), and data integrity principles.
• Strong technical documentation skills, including preparation and review of GMP records, reports, and procedures.
• Demonstrated ability to work collaboratively across Quality, Manufacturing, Warehouse, and Supply Chain functions.
• Experience working with biologics, nucleic acids, RNA products, sterile products, or other advanced therapeutics is desirable.

Skills and Attributes

• Sound knowledge of GMP, quality control processes, laboratory practices, and regulatory requirements.
• Strong commitment to quality, compliance, data integrity, and patient safety.
• Ability to analyse data, identify issues, assess risks, and support investigations.
• High level of accuracy and attention to detail in testing, documentation, and record management.
• Effective communication and collaboration skills, with the ability to work across multiple functions.
• Strong organisational skills with the ability to manage priorities, meet deadlines, and support continuous improvement.

Organisational Relationships

Reporting Line

This position reports directly to the QC Manager or designated QC Lead.

Direct Reports

This position has no direct reports.

Internal Relationships

• Quality Assurance
• Warehouse
• Facilities and Engineering

External Relationships

• Contract Development and Manufacturing Organisations (CDMOs)
• Suppliers and Service Providers
• Consultants and Subject Matter Experts