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.
Following some recent changes come and join the CSL Behring Quality Control (QC) Operational Support team on a full-time on-going basis
. As the QC Scientist Change Control,
you will provide operational support, technical expertise, and where required, oversight of designated support activities, such as coordinating change controls, updating documentation, and completing risk assessments within your QC team. You will also co-ordinate, prepare and conduct any reviews required to facilitate QC change management. You will ensure that all activities are completed following HSE, cGMP and relevant Regulatory and Quality requirements.The Role
Reporting to the Manager QC Operational Support and working on site
, you will:
Skills and Experience:
- Initiate, coordinate and participate as SME for local and global Control Change Management
- Where required, assist in the investigation and management of Out of Specification test results.
- Through direct involvement with work operations ensure that work performed is as per approved standard operating procedures and work instructions.
- Proactively identify and actively support continuous improvement opportunities; potential risks; and cGMP deficiencies to processes and documentation.
- Ensure deviations and CAPAs are closed within a timely manner.
- Participate in internal and regulatory audits conducted by the Quality and relevant regulatory.
- Support the introduction of changes within the delegated area at the CSL Behring Broadmeadows site. Where appropriate review, approve and oversee changes.
- Participate in site audits as SME and assist the QC team to prepare, manage and respond to all audit requests presenting audit responses.
- Encourage and contribute to a culture of continuous improvement.
To be considered for this role you have:
How to Apply:
- Bachelor’s degree in science, natural sciences, pharmacy, chemical engineering, or related field.
- 5+ years’ experience in the pharmaceutical, biotechnology or related industry with significant exposure to GMP or closely related environment.
- 3+ years’ experience with GxP regulatory requirements including industry guidance documents such as those required by TGA or FDA and the requirements of PICs and US CFR.
- Experience preparing written technical documents and presenting complex information.
- Experience in a role requiring multi-functional collaboration and the negotiation of outcomes including experience on large scale projects.
Please apply with your resume and covering letter, which must address the selection criteria above, and include the reference number R-220578
by 13th December, 2023
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!