Scientific Validation Professional

1 week ago

Sydney, New South Wales, Australia beBeeMolecular Full time $90,000 - $110,000

We are seeking a skilled professional to fill the role of Quality Assurance Specialist.

Job Summary:

The ideal candidate will possess experience in molecular biology, including real-time PCR, and have a strong background in assay development and validation. They will be responsible for performing analytical studies, assisting with process and equipment validation, and analysing data to identify problems and develop solutions.

Key Responsibilities:
  • Analytical Studies: Conduct detailed analyses of nucleic acid extraction kits and real-time PCR assays
  • Validation Support: Assist in the validation of processes, equipment, and computer software
  • Data Analysis: Analyse data to identify trends and patterns, and assist in problem-solving and experimental design
  • Documentation: Maintain accurate records of all tasks and activities, as required by our quality management system
  • Compliance: Ensure adherence to project management principles and regulatory requirements
Requirements:
  • Bachelor's degree in Biomedical Science or related field
  • Previous experience in assay development or validation, preferably in a regulated environment
  • Molecular biology expertise, including real-time PCR
  • Strong analytical and problem-solving skills
  • Flexible and adaptable attitude
  • Excellent time management and organisational skills
Deseables:
  • Experience with assay validation in compliance with TGA/FDA or EU regulations
  • Computer software validation experience
  • Ability to independently source technical information, formulate hypotheses, design experiments, and interpret results
  • ISO 13485 compliance
  • Familiarity with regulated environments and experience in undertaking controlled studies to support regulatory submissions

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