Senior Quality Assurance Specialist

3 weeks ago


Melbourne, Victoria, Australia Evolve Scientific Full time
About the Role

We are seeking a highly skilled Senior QA Associate to join our Site Inspections and Compliance team.

This is a 6-8 month casual contract, Monday – Friday, standard working hours, with flexibility to travel between sites.

The ideal candidate will have a strong background in quality assurance, regulatory compliance, and auditing.

Key Responsibilities
  • Support the preparation and execution of Self-Inspections to verify compliance with global GMP regulations and corporate requirements.
  • Identify and assess risks, and facilitate appropriate mitigations to ensure compliance and continuous improvement.
  • Participate and support regulatory inspections at Seqirus, including providing responses to regulatory authorities in a timely manner.
  • Maintain processes, procedures, and SOPs for auditing and inspections to improve audit readiness.
  • Work with global colleagues to support the harmonization, maintenance, and application of global audit strategy, processes, and SOPs.
  • Stay up to date with industry and regulatory trends to ensure compliance and continuous improvement.
  • Participate in local Quality Management Review and KPI preparation.
Requirements
  • Tertiary education in a scientific discipline.
  • Previous quality/manufacturing experience in a similar role in the biotechnology or pharmaceutical industry.
  • Experience as an auditor in internal and external audits.
  • Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations (preferred).
  • Knowledge of global cGMP regulations and ISO standards.
  • Excellent written and oral communication skills.
  • Ability to understand data sets and drive data-based decisions.
  • Excellent problem-solving skills and time management.
What We Offer

As a leading engineering staffing provider, we offer a range of benefits, including market-leading benefits packages and accommodation, to support our contractors in their roles.

We are committed to providing a safe and compliant working environment for all our contractors.



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