At Southern CDC, we partner with sponsors and sites across the clinical trials landscape to deliver high-quality, compliant clinical research outcomes. We’re building a reputation for operational excellence and regulatory rigour across Australia and the globe. We're passionate about doing clinical trials right, and we're looking for someone who shares that passion to join our Quality team.

Are you ready to help safeguard the integrity of our processes and support a culture of continuous improvement?

About the Role The QA Associate / Auditor plays a pivotal role in upholding the highest standards of excellence within our organisation. Responsible for meticulously examining and ensuring compliance with regulatory standards, study protocols and company procedures, our QA team safeguards the integrity of everything we do. This position requires a keen eye for detail, an analytical mindset, and a solid understanding of quality standards and procedures relevant to clinical research. Whether auditing internal processes or assessing external vendor compliance, your contributions will be crucial in maintaining and enhancing our reputation for quality.

Responsibilities & Duties

Conduct periodic audits and assessments of quality management systems and processes

Review and verify compliance with regulatory standards, clinical trial protocols and internal Standard Operating Procedures

Identify areas of non-compliance and recommend corrective actions

Document audit findings and prepare detailed reports for management

Collaborate with various departments to ensure quality standards are met and maintained

Develop and update quality control processes and procedures, in collaboration with department leaders and subject matter experts

Assist with coordination of external auditors / facilitate external audits, as applicable

Monitor the implementation and effectiveness of corrective and preventive actions (CAPA)

Analyse data to identify trends and areas for improvement





Summarise trend analysis and recommendations for internal stakeholders

Train staff on quality assurance policies, procedures, and industry best practices

Assist in developing quality assurance goals and objectives Qualifications & Skills

Required

Bachelor's degree in Quality Assurance, Science, or a related field

Minimum 3 years' experience in R&D;, pharmaceutical manufacturing, biotech, medical or laboratory settings, with some exposure to quality assurance or auditing

Experience with ISO 9001 or other relevant quality management systems within pharmaceutical, biotech, medical device or manufacturing industries

Knowledge of regulatory standards (including ICH-GCP, GxP, FDA, TGA and EMA) and compliance requirements

Proficiency in data analysis and statistical methods

Excellent communication and interpersonal skills, written and verbal

Strong analytical and problem-solving skills

Attention to detail and a commitment to maintaining high standards

Proficient in Microsoft Office Suite Desirable:

Certified Quality Auditor (CQA) certification

Experience with Atlassian Confluence and Jira

Experience in continuous improvement methods (Kaizen, Lean, Six Sigma, 5S)

Internal auditor / lead auditor certification (ISO 9001 / ISO 13485 / MDSAP) Attributes:

Inquisitive mindset with the ability to think laterally

Self-driven, reliable, and willing to take ownership

Strong organisational and time management abilities

Comfortable working both independently and collaboratively across cross-functional teams Why Join Southern CDC?

Be part of a growing, purpose-driven organisation making a genuine impact in clinical research across Australia and the Globe

Join a collaborative team culture that values quality, integrity, and continuous improvement

Enjoy a competitive compensation package and opportunities for career growth

Hybrid and flexible working arrangements to support work/life balance

Genuine career development pathways within a growing clinical trials organisation

Contribute directly to the protected and compliant delivery of clinical trials that improve patient outcomes

📌 Quality Assurance Associate (Melbourne)
🏢 Southern Clinical Development Consulting
📍 Melbourne