Quality Assurance Associate

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 RoleThe 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 & DutiesConduct periodic audits and assessments of quality management systems and processesReview and verify compliance with regulatory standards, clinical trial protocols and internal Standard Operating ProceduresIdentify areas of non-compliance and recommend corrective actionsDocument audit findings and prepare detailed reports for managementCollaborate with various departments to ensure quality standards are met and maintainedDevelop and update quality control processes and procedures, in collaboration with department leaders and subject matter expertsAssist with coordination of external auditors / facilitate external audits, as applicableMonitor the implementation and effectiveness of corrective and preventive actions (CAPA)Analyse data to identify trends and areas for improvementSummarise trend analysis and recommendations for internal stakeholdersTrain staff on quality assurance policies, procedures, and industry best practicesAssist in developing quality assurance goals and objectives
Qualifications & SkillsRequired:Bachelor's degree in Quality Assurance, Science, or a related fieldMinimum 3 years' experience in R&D, pharmaceutical manufacturing, biotech, medical or laboratory settings, with some exposure to quality assurance or auditingExperience with ISO 9001 or other relevant quality management systems within pharmaceutical, biotech, medical device or manufacturing industriesKnowledge of regulatory standards (including ICH-GCP, GxP, FDA, TGA and EMA) and compliance requirementsProficiency in data analysis and statistical methodsExcellent communication and interpersonal skills, written and verbalStrong analytical and problem-solving skillsAttention to detail and a commitment to maintaining high standardsProficient in Microsoft Office Suite
Desirable:Certified Quality Auditor (CQA) certificationExperience with Atlassian Confluence and JiraExperience 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 laterallySelf-driven, reliable, and willing to take ownershipStrong organisational and time management abilitiesComfortable 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 GlobeJoin a collaborative team culture that values quality, integrity, and continuous improvementEnjoy a competitive compensation package and opportunities for career growthHybrid and flexible working arrangements to support work/life balanceGenuine career development pathways within a growing clinical trials organisationContribute directly to the safe and compliant delivery of clinical trials that improve patient outcomes