Diagnostic Products Specialist

3 days ago

Sydney, New South Wales, Australia beBeeMolecular Full time $90,000 - $120,000

As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality and reliability of our molecular diagnostic products. Our innovative 3base technology enables us to provide configurable clinically relevant solutions for infectious diseases. We are seeking a skilled professional to perform quality control testing, stability testing, and assist with manufacturing activities.

The ideal candidate will have a minimum of BSc. in Biomedical Science or a related field, with a strong understanding of nucleic acid extraction, real-time PCR, and molecular diagnostics. Additionally, they should be familiar with regulatory requirements, such as FDA, HC, TGA, and IVD.

Key Responsibilities:
  • Perform quality control testing required for manufacturing and release of diagnostic products
  • Conduct stability testing to support shelf-life allocations and extensions
  • Implement production work plans according to agreed timelines
  • Assist with production and quality control of diagnostic kits when required
  • Record and address any observed non-conformances or stock discrepancies
  • Liaise with Production and R&D teams as necessary
  • Review and update production documentation, including business workflows and standard operating procedures
  • Follow manufacturing instructions meticulously and document all work efforts where required
  • Maintain safety, record-keeping, and quality standards
  • Support the transfer of products from development to manufacturing
  • Ensure compliance with Quality and Regulatory requirements
  • Liaise with cross-functional teams to ensure manufacturing activities meet QMS and regulatory requirements
Required Skills and Qualifications:
  • Bachelor's degree in Biomedical Science or a related field
  • Understanding of nucleic acid extraction, real-time PCR, and molecular diagnostics
  • Familiarity with regulatory requirements (FDA, HC, TGA, IVD)
  • Methodical production technique and record-keeping, aligned with Good Manufacturing Practice (GMP)
Benefits:
  • Ongoing training and professional development opportunities
  • A collaborative and dynamic work environment
  • The chance to contribute to the development of cutting-edge diagnostic products
What We Offer:
  • A competitive compensation package
  • A comprehensive benefits program
  • The opportunity to work with a global leader in molecular diagnostics

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