Quality Assurance
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Senior Quality Associate - Preclinical & Laboratory QualityCSL Behring • VIC, AU
Senior Quality Associate - Preclinical & Laboratory Quality
CSL Behring • VIC, AU
8 days ago
Job description
We are seeking an experienced Senior Quality Associate to join our PreClinical Laboratory Quality Assurance team in Melbourne. This is an exciting opportunity to contribute to the quality and compliance framework supporting preclinical and laboratory operations across research and development activities.
The Opportunity
Reporting to the PreClinical Laboratory Quality Assurance Lead, you will play a key role in ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), ISO/IEC 17025, and other applicable quality requirements. You will partner closely with R&D teams to support quality systems, inspection readiness, regulatory compliance, and continuous improvement initiatives.
This role is a hybrid role which will be based at our Elizabeth St office in Melbourne.
Key Responsibilities
In this role, you will:
Support the implementation and maintenance of quality systems and compliance processes across preclinical and laboratory functions.
Partner with R&D stakeholders to establish and maintain quality procedures, standards, and systems.
Review and approve study plans, protocols, reports, and supporting documentation to ensure GLP/GCLP compliance.
Conduct quality inspections, including facility, study, process, document, and ISO 17025 inspections.
Support internal and external regulatory inspections and audit activities.
Manage and facilitate deviations, change controls, and corrective and preventive actions (CAPAs).
Assess quality risks and provide guidance on compliance-related matters.
Review assay method development and equipment validation documentation.
Support key quality metrics and reporting activities.
Promote a strong quality culture and drive continuous improvement across the organisation
About You
To be successful in this role, you will bring:
Qualifications
Degree in Biological Sciences, Life Sciences, or a related scientific discipline.
Experience
Experience working within GLP, GCLP, GxP, Quality Assurance, laboratory, or process development environments.
Knowledge and practical application of quality systems and compliance frameworks.
Experience supporting quality activities within R&D, product development, laboratory, or regulated environments.
Strong understanding of GLP requirements and quality principles.
Knowledge of ISO/IEC 17025 laboratory requirements.
Excellent planning, organisational, and stakeholder management skills.
Strong communication, presentation, and influencing abilities.
Proven ability to identify opportunities for continuous improvement and drive positive outcomes.
Customer-focused approach with strong problem-solving and decision-making capabilities.
Why CSL?
At CSL, you'll have the opportunity to work alongside talented professionals in a purpose-driven environment where your contributions make a real impact. We offer:
Meaningful work that improves patient lives globally.
Career development and growth opportunities.
A collaborative and inclusive culture.
Access to world-class research, quality, and manufacturing environments.
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Senior Quality Associate - Preclinical & Laboratory Quality • VIC, AU
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