Senior Aseptic Manufacturing Specialist

3 days ago

Melbourne, Victoria, Australia beBeeSterility Full time $98,765 - $123,456

Quality Assurance Expert Wanted

We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Sterility Assurance Specialist, you will play a key role in ensuring our manufacturing environments meet the highest standards of compliance and quality.

The successful candidate will support contamination control strategies, environmental monitoring, and aseptic process governance across our operations.

This is a fixed-term role with an opportunity to work from home as needed.

Key Responsibilities:
  • Support and maintain sterility assurance systems aligned with global standards and GMP regulations.
  • Lead and contribute to contamination control strategies, including aseptic process simulation, cleaning and disinfection programs, and aseptic behavior training.
  • Collaborate with cross-functional teams to drive continuous improvement and ensure regulatory compliance.
  • Participate in internal audits, inspections, and regulatory submissions as a Sterility Assurance SME.
  • Support deviation investigations and change control processes related to aseptic manufacturing.

Requirements:

  • Bachelor's degree in Microbiology, Biochemistry, Pharmaceutical Sciences, or a related field.
  • Strong background in aseptic manufacturing, sterility assurance, and quality assurance preferably in a pharmaceutical manufacturing or cGMP-regulated environment.
  • Experience in environmental monitoring, microbiology, and contamination control.
  • Proven ability to work collaboratively across teams and influence key stakeholders.
  • Ability to gown and work in cleanroom environments is essential.

Benefits:

  • Opportunity to work with a leading healthcare company.
  • Competitive salary and benefits package.
  • Professional development opportunities.

About Us:

Our company is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.

Why Join Us?

Join a dynamic team dedicated to delivering high-quality products and services.

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