Who We Are

Cell Therapies Pty Ltd (CTPL) is an incorporated Australian Proprietary Company which manufactures and deploys advanced cell-based therapies to the global cell and gene therapy (CGT) market.

The evolution of Cell Therapies Pty Ltd will continue through its commitment to supporting local and international research and development activities in addition to a pipeline of new commercial contracts supplying Australian and International patients.

About the Role

The QA Associate (Auditing) is responsible for the Quality and auditing support of activities for the manufacturing and QA areas, to ensure GMP compliance for the clinical and commercial manufacturing and distribution of cellular and tissue therapy products.

Throughout the week you will be involved in helping assess compliance, identify gaps, and drive continuous improvement initiatives within the Quality Management System (QMS) and provide overall quality support to the relevant departments and QA team.

This is a Full-time Position, located at our new, state-of-the-art Melbourne facility, in the Peter MacCallum Cancer Centre on the edge of the CBD in Australia's most dynamic biomedical precinct.

To be successful in this role

• Strong knowledge of GMP compliance, auditing processes and regulatory requirements for human cells and tissues.
• Experience conducting internal and vendor quality audits, identifying non-conformances and ensuring corrective actions are effectively implemented.
• Ability to support the continuous improvement of the Quality Management System by identifying gaps and driving compliance with regulatory guidelines.
• Excellent organisational skills with the ability to manage and meet auditing and performance objectives.
• Strong attention to detail and the ability to provide timely, sound advice to stakeholders, including QA Manager and cross-functional teams.
• Effective communication and teamwork skills to collaborate with Manufacturing, QC and other departments in maintaining quality standards.
• Experience supporting deviation investigations, CAPA processes and batch record reviews to meet defined timeframes and GMP requirements.
• Commitment to continuous learning and staying up to date with relevant regulatory frameworks.
• Ability to provide guidance and training on audit findings and quality system improvements.

Skills & Experience

Essential:

• Experience working in a GMP environment with a focus on auditing and compliance support
• Strong understanding of the requirements of the relevant codes of Good Manufacturing Practice (e.g. TGA, FDA, PIC/S, and EMA) as they are applied within a biological manufacturing setting
• Track record of efficient management and resolution of quality processes, Vendor / Supplier and Quality audits, using consultation and SME input to assess compliance risks and provide corrective action recommendations
• Good communication and relationship building skills
• Ability to work independently and objectively in auditing and quality oversight functions
• Demonstrated problem solving and decision making skills
• A tertiary qualification in a relevant scientific discipline

Desirable:

• Experience working in an ISO14644 classified environment for a sterile or aseptic process
• Understanding of product development
• Experience in internal / external Quality audits

This is a great opportunity for a driven, collaborative and curious professional to join an organisation with purpose, passion for excellence and the aspiration to be a global leader in cell and gene therapy.

At CTPL we are passionate about the work we do but equally passionate about our people. We want everyone to bring their true self to work. We support the wellbeing of our staff through mindfulness sessions, continuous improvement activities and 5 wellness days a year.

The salary offered will be commensurate with skills, experience and industry standards. Company specific GMP training will be provided as part of the induction process.

In applying, please provide your CV and a cover letter that addresses the key selection criteria.

* We will not be liable for any fees and cost associated with unsolicited CVs sent to us from recruitment agencies.