Quality Assurance Associate

4 weeks ago

Broadmeadows, Australia CSL Behring Full time

**The Opportunity**:
Join the CSL Behring Quality team based in **on-site** at **Broadmeadows **(Australia) on a full-time **permanent **basis. CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by the Lifeblood Australia. Part of the CSL family, when you join the over 1200 employees at Broadmeadows, you join an integrated global network of research and manufacturing facilities delivering on our 100-year-old promise to save lives using the latest technology.

As the **Quality Assurance Associate **you will ensure the appropriate quality of systems and processes, adherence to any applicable CSL standards and procedures and review and approve related records. You will also support quality risk assessments, non-conformances, investigations, CAPAs, change controls, and the monitoring and continuous improvement of quality performance metrics. Specifically, will gain valuable technical knowledge as you support the Packaging Value Stream.

**The Role**:
Reporting to the Senior Manager QA Value Stream Packaging, you will:

- Oversee all production and support related activities to provide real time (GEMBA) and post event (CCIT) review of process steps, media filling and visual inspection
- Review all batch documentation required for final batch disposition following agreed timelines
- Assessment and escalation of identified issues to ensure review is completed to meet batch release timelines;
- Perform QA review and approval of operational and processing records to ensure compliance with regulatory requirements and CSL procedures
- Provide real-time quality guidance and be the contact point for escalations;
- Complete in-process checks, sampling and inspection for AQL processes.
- Ensure the appropriate review and approval of related quality records;
- Deliver training of systems and processes to value stream partners;
- Support quality risk assessments, non-conformances, investigations, CAPAs and change controls;
- Support monitoring and continuous improvement of quality performance metrics.

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

- Bachelor’s Degree in Science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical science or equivalent qualification or experience
- Minimum of three (3) years working in a similar role
- Experience in the manufacture of sterile injectable pharmaceutical products including manufacture and packaging of blood products;
- Experience in: operational pharmaceutical manufacturing, technical support and the manufacture and packaging of blood products
- Experience in pharmaceutical quality and compliance including health authority expectations and inspections
- Experience in a role requiring analysis of information and determining and communicating risk-based quality decisions
- Proficient in the use of the Veeva QMS and electronic document management systems (eDMSs)

**How to apply**:
Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number **R-205419** by **27 July 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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