Senior Quality Assurance Specialist

2 days ago

Newcastle, New South Wales, Australia beBeeQuality Full time $100,000 - $140,000
Quality Management Professional

Our organization is seeking a highly skilled Quality Management Professional to support our oncolytic immunotherapy pipelines.

Key Responsibilities:
  • 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. This may include quality-related issues with external CMOs, CROs, clinical sites, and shipments.
  • Manage quality-related clinical product distribution procedures, including review of temperature excursions.
  • Cover all necessary GxP activities; especially GMP.
  • Support the regulatory team with documentation and QC reviews.
Requirements:
  • 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; and especially the cGMP environment.
  • Strong English language skills - verbal and written.
  • Superior level of skill and attention to detail regarding editing and manipulating documents (e.g., hyperlinking within document, formatting, referencing, etc).
  • Superior organizational skills.
  • Team player, but also able to work independently.
  • Adaptable/flexible.

Desirable skills and experience include:

  • Experience with pharmaceuticals and specifically oncolytic virus is a significant advantage.
  • Prior experience supporting regulatory submissions.
  • Experience in supporting CMC activities.
  • Experience with management of clinical trial samples.
  • Experience working in a small-sized biotechnology company.

This role is ideally full-time, but applications for part-time work will be considered.

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