Bio Technology Quality Assurance Specialist

5 days ago

Brisbane, Queensland, Australia beBeeQuality Full time $140,000 - $160,000
Biotechnology Quality Assurance Specialist

We are seeking an experienced Biotechnology Quality Assurance Specialist to support our Brisbane site in manufacturing bio-pharmaceutical products and ensuring compliance with quality requirements.

Key Responsibilities:
  • Liaise with clients and project managers regarding quality requirements, efficiently handle client queries, and supply relevant information and results.
  • Collaborate with QC labs, QA, program management, warehouse, and logistics teams to ensure timely and accurate output of data from stability studies, batch testing, and external shipments.
  • Generate shipping documentation and sample submission forms for testing at external facilities, review and approve test reports supplied from external facilities.
  • Perform aseptic aliquoting of bulk samples and support quality control laboratory teams to ensure relevant testing is performed on time and accordance with regulatory guidelines.
Requirements:
  • Bachelor of Science degree in Bio-Technology, Chemistry, or closely related field.
  • At least 2 years' industry work experience in analytical and quality control fields, knowledge of test method development, qualification, validation, cGMP practices, and quality management systems.
  • Experience in stability studies suitable for the bio-pharmaceutical industry, good attention to detail, ability to prioritize multiple client programs and reports simultaneously.
What We Offer:
  • Comprehensive benefits including private health insurance, risk benefits insurance, wellness programs, and employee assistance programs.
  • Flexible arrangements, generous leave policies, and paid volunteer time to support non-profit organizations.
  • Access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

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