Document Administrator

About the Role

We are seeking a motivated Document Administrator to ensure documents are managed as per the Quality Management System and ensure QMS, GMP compliance for the clinical and commercial manufacturing and distribution of cellular and tissue therapy products.

As a Document Administrator, you’ll play a crucial role in ensuring the accuracy and timely processing of essential documentation such as batch records, protocols and labels based on the Production, Quality Control and Validation schedules for our GMP Cell Therapy manufacturing facility. This role helps ensure quality and safety of our products and that they meet the highest standards of compliance and patient care.

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 

• Ensure document management aligns with the Quality Management System to maintain GMP compliance in clinical and commercial manufacturing.
• Control document issuance and formatting according to SOPs, ensuring timely access for manufacturing needs.
• Manage all batch records to meet manufacturing schedules, ensuring documents are controlled, archived and retrievable per SOPs and client requirements.
• Collaborate effectively with the QA team and other departments to maintain documentation flow and support quality assurance initiatives.
• Manage both physical and electronic archives, ensuring documents are properly stored and retrievable.
• Issue critical documents and labels for process and final product materials to relevant departments such as production and QC.
• Maintain and update the electronic quality management system to keep all documents accessible and current.
• Participate in continuous improvement activities, identifying and addressing documentation system issues.
• Ensure compliance with cGMP, PIC/S and relevant clinical requirements.
• Support QA team members with documentation needs and ensure clear communication across teams.
• Adhere to health, safety, and environmental policies, promoting a safe workplace and participating in risk assessments and incident investigations.

Skills & Experience

Essential:

• Advanced Microsoft Word skills experience
• Ability to follow procedures and defined work-flows
• Demonstrable ability to work and communicate cooperatively with multiple teams and competing demands
• Excellent attention to detail
• Responsible attitude and work ethic
• Ability to multitask and work autonomously as well as in teams

Desirable:

• Specific experience in document control in a cGMP compliant service

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 a cover letter that addresses the key selection criteria. All applicants should apply through SEEK.

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