Join the CSL Behring Quality Assurance (QA) Compliance team 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 Senior Associate QA Support, you will partner with all the teams within the site value streams to assure the appropriate quality of systems and processes therein, adherence to any applicable CSL standards and procedures, and review and approve related records. You will also support and approve quality risk assessments, non-conformances, investigations, CAPAs, and change controls, and promote new ways of working and the continuous improvement of quality performance metrics.
The Role
Reporting to the Senior Manager, QA Value Stream Support Functions, and working on-site at Broadmeadows, you will:
- Support all quality related activities for the Support Functions value stream including projects to ensure that all relevant policies regulations and guidelines are being followed
- Manage deviation business process including investigations and SQuIPP meetings to meet the DIFOT schedule to ensure consistent supply of product to patients and develop effective CAPAs
- Review and approve documentation related to Extractable and Leachable for validation
- Manage and track change controls and facilitate their close out and participate in document control related activities
- Take the lead and manage quality investigations, deviation management and other Quality and Production activities, including supporting peers and other CSL Departments by coaching, training, and developing others.
- Collaborate with global QA colleagues and represent Quality Assurance Operations on local and global projects and serve on steering committees.
Your experience
- A degree in science or engineering or pharmaceutical science
- 5+ years' experience in a similar role in the pharmaceutical manufacturing industry in a cGXP environment
- Experience with GxP regulatory requirements including industry guidance documents such as those required by TGA or FDA
- Experience leading a technical team in a regulated environment and providing technical support
- Experience preparing written technical documents and presenting complex information
- Experience in a role requiring multi-functional collaboration and the negotiation of outcomes
- Experience in a role requiring conceptual and analytical thinking to reconcile ambiguities.
How to Apply:
Please apply with your resume and covering letter, which must address the selection criteria above, and include the reference number R-202467 by May 17, 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.
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