Sterility Assurance Specialist

2 days ago

Sydney, New South Wales, Australia beBeeMicrobiologist Full time $90,000 - $130,000
Expert in Sterility Assurance

At our organization, we're dedicated to delivering high-quality healthcare solutions. As a sterility assurance expert, you'll play a pivotal role in supporting and influencing the achievement of quality systems and good manufacturing practice within manufacturing and manufacturing-related functions.

Our team is committed to improving patient outcomes through innovative medical technologies. If you're passionate about microbiology and want to make a difference, we encourage you to apply for this exciting opportunity.

The Role:
  • Assess impact and perform required testing for sterility assurance on products and processes in accordance with GMP regulations.
  • Participate in internal audit programs and conduct real-time risk assessments.
  • Proficiently perform all testing requirements for the manufacturing facility, ensuring practices align with established procedures.

Key Requirements:

  • Tertiary degree in Microbiology, Biology, or related fields.
  • 3-5 years proven experience in microbiology within a manufacturing environment.
  • Outstanding understanding of GMP, GDP, and GLP principles.

Benefits:

We value our employees' contributions and strive to create a positive work environment. Our relationships are built on trust, reliability, and open communication. We prioritize inclusion and diversity, promoting gender equality in the workplace.

Responsibilities:
  • Compile and ensure all testing for critical work orders, validations, and manufacturing environments are completed following shutdowns and critical systems work.
  • Conduct routine water testing on non-distilled and distilled water throughout the manufacturing facility.
  • Review and approve atypical sterilization cycles, recommending the status of affected loads.
  • Prepare protocols and reports for validation or projects related to processes, environmental, and microbial studies.

We believe in empowering our employees to grow professionally and personally. Apply now and become part of our team of experts dedicated to saving and sustaining lives

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