Senior Quality Assurance Specialist

2 days ago

NewcastleMaitland, Australia beBeeQuality Full time $100,000 - $120,000

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.

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