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QC Scientist- Operational Support

Employer
CSL - Australia
Location
Broadmeadows, AU
Salary
Competitive
Start date
30 Nov 2023
Closing date
14 Dec 2023

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

The Opportunity:

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:
  • 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.


Skills and Experience:

To be considered for this role you have:
  • 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.


How to Apply:

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.

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!

Company

Find out more about working for our company

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Brief Company Description; 

Driven by Our Promise

Delivering on promises is what we do at CSL.

Over a century ago in Melbourne, Australia, we made a promise to save lives and protect the health of people who were stricken with a range of serious and chronic medical conditions. Today, as a leading global biotech company, that same promise has never been stronger. We develop and deliver innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions live full lives. We are driven by our deep passion to serve hundreds of thousands of patients and other stakeholders around the world.

Company info
Website
Mini-site
CSL - Australia
Telephone
+61 3 9389 1911
Location
45 Poplar Road
Parkville
VIC
3052
Australia

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