Assoc QA Batch Release
The Opportunity
We are looking for an experienced Associate, Quality Assurance(QA) to join our diverse Batch Release team at Seqirus, Parkville (Australia). You will review batch manufacturing documentation according to schedule to ensure the batch documentation meets the required quality standards, registered specifications and the approved manufacturing process. You also will provide QA expertise to the site and work with manufacturing and quality control to achieve outcomes.
This is a full time, Fixed term position until 29 August 2025.
The Role:
Reporting to the Senior Associate or Manager, Quality Assurance, you will:
- Review manufacturing documentation to ensure that raw materials, intermediates, and final products are suitable for further processing or release, following documented batch process sheets/procedures Perform Visual Inspections on Intermediate and Finished Products
- Co-ordinate product samples for submission to regulatory agencies
- Support maintenance of quality systems relating to batch release and help develop training modules
- Provide administrative support, including data entry and review for business systems, including the electronic Quality Management System (eQMS), Laboratory Information Management System (LIMS), Enterprise Resource Planning (ERP) system, and Document Management System.
Your experience:
To be considered for this role, you have:
- University degree in a relevant scientific discipline (Pharmacy, Chemistry, Microbiology, or Biochemistry);
- 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry with a focus on QA.
- Experience with Regulatory Standards (TGA (PIC/S), FDA (CFR) and ISO-13485), Quality Risk Management, Quality Control and Quality Assurance systems;
- Experience working with quality and manufacturing teams to achieve outcomes
- Experience in a role requiring analysis and accuracy;
- Experience completing goals within established time frames;
- Knowledge of TrackWise, SAP, LIMS and documentation management systems.
How to apply:
Please send us your resume and covering letter (in one document), addressing the key selection criteria. Applications close on 28 August 2024.
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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.
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.
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
