Sterility Assurance Associate

3 weeks ago

Broadmeadows, Australia CSL Behring Full time

We are looking for a **Sterility Assurance Associate** to join our Global Quality Operations team on a full-time basis **permanent **basis**.** Reporting to the Sterility Assurance Subject Matter Expert (SME) and based at our **Broadmeadows **Facility, you will provide expertise and lifecycle management of Sterility Assurance (SA) controls for governance, validation and environmental monitoring across the BMW site. You will also work with global SA teams to provide a holistic microbial contamination control strategy and improvement plan.

**The Role**:
In this diverse high-profile role, you will:

- Create documents for SOPs, risk assessments, trend reports and other SA documentation to maintain compliance to GMP and help prepare regulatory submissions;
- Help develop the environmental and personnel monitoring programme;
- Provide SME input for in-process testing, finished product testing and microbial method validation;
- Participate in validation and qualification of the facility, utility and equipment, process, personnel and method;
- Support cleaning and disinfection, hygiene, gowning, aseptic behaviours, facility and process design through the delivery of aseptic training to relevant partners across the site;
- Support implementation and maintenance of sterility assurance standards and processes following global company policy, regulatory requirements and industry standards;
- Represent SA on site projects to help set expectations regarding sterility related compliance;
- Be the catalyst for change and continuous improvement in SA;
- Maintain metrics for activities performed and ensure all site and global goals are exceeded;
- Contribute to the continuing improvement of safety and the safety culture as a role model.

**Your skills and experience**:
To be considered for this role you must have:

- A bachelor's degree in Microbiology or Biology life sciences or equivalent;
- 3+ years' experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing;
- 3+ years' experience in sterility assurance of aseptic cleanroom facilities, their processes and equipment including design validation and monitoring, including aseptic gowning qualification;
- Experience in a role requiring interaction with regulatory authorities including submissions and inspections;
- Experience in quality assurance and regulatory compliance with cGMP, TGA, FDA and other regulatory agency guidelines;
- Experience in a role requiring collaboration with partners at all levels, data-based decision-making and accuracy.

**How to apply**:Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number **R-193773 **by **14 January 2023**.

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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