Associate Quality Assurance

5 days ago

Melbourne, Australia CSL Full time

The Opportunity:
We are looking for an Associate Quality Assurance to join the CSL Behring Quality team to support the Bulk and recombinant Value Stream at our Broadmeadows site. You will promote the integrity of our processes, support the approval of records, conduct quality risk assessments, address non-conformances, manage investigations, CAPAs, oversee change controls, and drive continuous improvement in our quality performance metrics.

This is a Fixed term/ Secondment (for internal employees) until December 2025.

Key Responsibilities:
Reporting to the QA Bulk Manager, you will:

- Oversee production and support activities, providing real-time and post-event quality oversight.
- Perform QA approval of operational, processing and records to ensure compliance following the regulatory requirements.
- Ensure review of all documentation that is required for batch disposition.
- Assessment and escalation of identified issues to ensure review is completed to meet batch release timelines.
- Manage deviation processes, including risk assessments, root cause analysis and CAPAs, support the change control processes.

**Experience**:

- Bachelor's degree in science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical Science, or equivalent.
- 3+ years of experience in a similar role within pharmaceutical manufacturing or quality assurance.
- Strong knowledge of GMP, regulatory requirements, and quality compliance.
- Experience in deviation management, investigations and CAPA.
- Excellent problem-solving, organizational, and interpersonal skills.

Why Join Us?

At CSL Behring, we offer a supportive and inclusive work environment where your contributions are valued. We are committed to your professional growth, providing opportunities for learning and career advancement. Join us in our mission to improve the quality of life for patients worldwide.

LI-Onsite

**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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