Job Description: We are seeking a Senior Quality Associate to join our team at the Hunter Medical Research Institute in Newcastle. As a key member of our Quality Management team, you will play a critical role in ensuring the quality of our oncolytic immunotherapy pipelines across various stages of development.
About the Role
This is a senior-level position that reports directly to the Director of Quality Management. You will be responsible for supporting Chemistry, Manufacturing, and Control (CMC) activities, including in-house manufacturing and quality control testing, document management for clinical trials, and sample analysis.
* Support all manufacturing activities, including batch record collection and batch reviews.
* Develop, manage, and implement the Quality Management System (QMS) spanning R&D activities, product development, and commercialization activities for our oncolytic immunotherapy products.
* Manage GxP vendor qualification, audits, and reviews.
* Facilitate investigations, deviations, and CAPAs within the QMS, including quality-related issues with external CMOs, CROs, clinical sites, and shipments.
* Manage quality-related clinical product distribution procedures, including review of temperature excursions.
Required Skills and Qualifications:
* Degree in biological/biomedical sciences, pharmacy degree, or comparable.
* At least 3 years' quality management experience in the pharmaceutical/biotechnology industry is essential.
* Experience within GxP, especially the cGMP environment.
* Strong English language skills - verbal and written.
* Superior level of skill and attention to detail regarding editing and manipulating documents.
* Superior organizational skills.
* Team player, but also able to work independently.
* Adaptable/flexible.
Benefits:
This role offers a unique opportunity to contribute to the success of our organization and advance your career in quality management.
Others:
Please note that this job description is not an exhaustive list of responsibilities. You may be required to perform other duties as needed.