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Quality Assurance Specialist

4 weeks ago

Brisbane, Queensland, Australia KE Select Full time

Located in Brisbane, this Quality Scientist role is a temporary position covering maternity leave. Our client, a global organisation with state-of-the-art facilities, specialises in commercial and clinical manufacturing across the Pharmaceutical, Biotechnology, and Life Science sectors.

The successful candidate will report to the quality leader and ensure that the technical transfer and validation processes are completed according to quality and regulatory requirements. This role involves customer interaction and requires support for QC equipment ensuring compliance.

This is an exciting opportunity for someone to join an organisation that prides itself on having a culture of engagement and accountability, and who genuinely wants to provide excellent service.

Job Description
  • Client management on specific projects - managing expectations, challenges
  • Preparation of batch documentation/data, review protocols and reports
  • Investigate and evaluate new methods/techniques and manage control activities
  • Liaise with internal stakeholders, specifically QC laboratory teams issuing relevant test methods for routine use.
  • Author analytical method transfer, feasibility, qualification and validation protocols and reports in line with internal policies and regulatory guidelines.
  • Practical application of the Quality System, Change Control, Deviations, CAPAs, and Document Management, related to the Quality Control Department.
Key Responsibilities
  • Bachelor of Science (Chemistry, Biochemistry, Biotechnology)
  • Knowledgeable in GMP, NATA and cGMP
  • Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives
  • Proven record of ability to work as a team member and independently as required
  • Ability to effectively communicate in multiple modalities (e.g. electronic, written, verbal, etc.)
  • Knowledge of working with test method development, qualification, validation
  • Experience in laboratory testing techniques, assay development or analytical method validation for the manufacturing industry.
About the Opportunity

This casual temporary role offers a competitive salary of $80,000 per annum, plus benefits. If you have the necessary experience and skills, please contact us for a confidential discussion.