Sterility Assurance Associate
- Join a high-performing Global Quality team as a Sterility Assurance Associate.
- Provide technical expertise and quality oversight across sterility assurance programs.
- Support compliance with global regulatory requirements and CSL standards.
We are seeking an Associate Sterility Assurance to join a high-performing Global Quality team. Reporting to the Sterility Assurance Lead.
You will provide technical expertise and quality oversight across sterility assurance programs, collaborating closely with Manufacturing, Quality, Engineering, Validation, and Global Sterility Assurance teams. You will support the governance, implementation, and lifecycle management of sterility assurance controls while ensuring compliance with global regulatory requirements and CSL standards.
This is a part-time role (19 hours) based at our Broadmeadows site.
Key Responsibilities
- Support and maintain site-wide sterility assurance programs and microbial contamination control strategies.
- Provide technical oversight of environmental monitoring, personnel monitoring, in-process testing, finished product testing, and microbiological methods.
- Support qualification and validation activities for facilities, utilities, equipment, processes, personnel, and microbiological methods.
- Prepare and review validation protocols, reports, SOPs, risk assessments, trend reports, and quality documentation.
- Assist with investigations related to microbial contamination events, deviations, CAPAs, and root cause analyses.
- Partner with global and local stakeholders to ensure alignment with sterility assurance standards and best practices across the manufacturing network.
- Support regulatory submissions and inspections, including interactions with health authorities and auditors.
- Deliver aseptic behavior, gowning, and contamination control training to site personnel.
- Drive continuous improvement initiatives that enhance quality, compliance, and operational efficiency.
About You
You are a quality-focused professional with strong technical expertise and a collaborative mindset, who thrives in a regulated manufacturing environment.
To be successful, you will have:
- 3+ years’ experience in pharmaceutical or biopharmaceutical manufacturing with sterility assurance responsibilities.
- Experience working within aseptic processing and cleanroom environments.
- Knowledge of microbial monitoring, contamination control, validation, and lifecycle management.
- Understanding of cGMP requirements and regulatory expectations, including FDA, TGA, EU GMP, and PIC/S guidelines.
- Strong investigation, problem-solving, and risk assessment capabilities.
- Excellent communication and stakeholder management skills.
- Ability to influence cross-functional teams and drive quality outcomes.
- Ability to aseptically gown and enter sterile manufacturing environments.
- Excellent analytical thinking and risk assessment capabilities
- Ability to thrive in complex, cross-functional environments
- High attention to detail and strong documentation review skills
- Effective communication and stakeholder management skills
Why Apply?
- Work within a globally recognised pharmaceutical organisation
- Play a key role in ensuring product sterility and patient safety
- Exposure to cutting-edge sterile manufacturing technologies
- Opportunity to drive global standards and continuous improvement initiatives
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Skills
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