QC Support Analyst

3 weeks ago

Parkville, Australia 3085 Seqirus Pty Full time

The Opportunity

CSL Seqirus is looking for a Quality Control (QC) Analyst to join our QC Support department in the QC Compliance and QC Sample Receipt area, on a part-time basis (3 days a week). This is a fixed term contract until 31 December 2025.

Based at Parkville site and reporting to the Team leader - QC Support, you will support a team responsible for management of laboratory distribution of production samples for QC testing, tracking, and monitoring of Quality Control compliance activities, and administrative support to other QC Departments to meet business requirements.

The Role

  • Provide efficient and reliable service to customers of QC.
  • Logging and receipting QC testing samples into Laboratory information Management Systems (LIMS/GLIMS).
  • Checking the condition of submitted samples, labels, and paperwork and resolving any identified errors and anomalies with the submitting departments.
  • Preparing and arranging sample logistics for external testing.
  • Co-ordinate the calibration of instruments as required and maintain the operations of the QC Sample Receipt area.
  • Assist with investigations of Out of Specification (OOS) test results, invalid assays or Out of Trend (OOT) data and complete TrackWise/Veeva investigation, change control, CAPA and audit actions as required.
  • Assist in the preparation of internal and external audit responses and provide regular updates on progress and timelines to QC Team Leader/Manager.
  • Actively seek, recommend and implement improvements to enhance quality within QC Support.
  • Follows Standard Operating Procedures (SOPs) and maintains compliance to current Good Manufacturing Practice (cGMP) regulatory guidelines.
  • Monitor and report observed temperatures in Sample Receipt and / or other QC Facility temperature-controlled areas.

Your Skills and Experience

  • Tertiary qualification in a related scientific discipline.
  • 1 + years' experience in quality control testing in a GxP lab in a highly regulated environment.
  • Knowledge of cGMP standards.
  • Experienced in accurately maintain testing records, analysing data, and scientific report writing.
  • Proficient in computer applications and systems including TrackWise, LIMS, SAP.
  • Excellent customer focus and the ability to work collaboratively with internal stakeholders to solve problems.
  • Demonstrate a high level of attention to detail and a commitment to working in a team environment.

How to apply

Please submit your application including your CV and Cover Letter by 21 June 2024.

#LI-Onsite

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

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus

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