Lims/em Data Administrator

2 weeks ago

Tullamarine, Australia Seqirus A CSL Company Full time
The Opportunity


We are looking for an Administrator to join the Quality Control (QC) team on our exciting Banksia Project constructing an advanced Influenza cell-culture (FCC) manufacturing facility in Tullamarine (Victoria, Australia).


Based at Tullamarine, as the LIMS & Environmental Monitoring Data Administrator you will ensure that the Laboratory Information Management System (LIMS), which guarantees that Products of National Significance (PNS) and Flu-Cell Culture (FCC) products, materials and processes, will continue to function as required.

You will create master data and implement LIMS solutions to ensure the business can operate efficiently, compliantly, and uninterrupted after LIMS is rolled out to the Seqirus (Tullamarine/ Woodend) and CSL Behring (Broadmeadows) sites.

This is fixed term role until 30 November 2024.

The Role

Reporting to the QC Systems Lead for Banksia, you will:

  • Collaborate with the Banksia QC Systems Lead, Banksia GLIMS Project Manager and QC GLIMS SME, to deliver processes and transactions relating to LIMS for Project Banksia
  • Conduct LIMS system testing, handover of documentation and training of the relevant users in use of LIMS systemplement master data updates through the change control process and associated systems
  • Assist and contribute to the Change Management team with the preparation and delivery of the LIMS System activities for Project Banksia and other affected partners
  • Implement approved solutions to any feedback from the business affected by the rollout of Quality System processes
  • Develop and implement new methods and procedures, and maintain standard operating procedures
  • Ensure that all aspects of the QC LIMS project comply with the requirements of the Quality Manual and meets all relevant cGMP regulatory requirements.
Your skills and experience

To be considered for this role you have:

  • Bachelor's degree in a related scientific discipline (Chemistry, Biology, Biochemistry)
  • 5+ years' experience in Quality Control laboratory operation and/or a GMP regulated environment within the pharmaceutical industry
  • Experience with Labware software and laboratory system operations
  • Experience working in a Programme environment, in a multisystem operating landscape, which may include (but is not limited to) SAP, GLIMS, TrackWise, Document Management Systems, Learning Management Systems and SharePoint
  • Knowledge of current Good Manufacturing Practices (cGMP) principles
  • Knowledge of FDA, TGA and EMA requirements
  • Experience in a role requiring the completion of multiple, competing, tasks within specified timelines

How to apply:


Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R by November 24, 2023.

Our Benefits


CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.

Learn more about some of the

benefits

you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (

ASX:
CSL).

As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.

In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL

Seqirus

We want CSL Seqirus 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 Seqirus.

Do work that matters at CSL Seqirus

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