About the Company
We are partnered with a rapidly growing CDMO focused on the development, manufacturing of mRNA raw materials and vaccines. Our client's facility will specialise in GMP manufacturing of mRNA drug substances used for phase I & II clinical trials.
We're looking for an enthusiastic and skilled Quality Assurance Associate to join this dynamic team. The successful candidate will be part of building a phase-appropriate Pharmaceutical Quality System (PQS) aligned with ICH and PIC/S guidelines and will work cross-functionally to ensure regulatory compliance and operational excellence.
Key Responsibilities: Vendor Assurance Management - Establish and maintain a robust vendor management system
- Conduct vendor assessments and criticality rankings
- Develop and manage service agreements
- Perform risk-based vendor reassessments
Material Management - Support the development of a material management system
- Write and review material specifications and worksheets
Documentation & Quality Systems - Author and review SOPs, specifications, and operational documents
- Support quality systems including deviations, CAPAs, and change control
Computer System Management - Administer lab and production system users
- Ensure data integrity compliance, including audit trail reviews
About You - Background in biologics or pharmaceuticals with tertiary qualifications in a relevant scientific/engineering discipline.
- Strong hands-on GMP experience in biologics or pharmaceutical manufacturing
- Demonstrated experience in quality assurance roles
- Familiarity with Australian manufacturing standards and TGA expectations
- Excellent attention to detail and commitment to quality
How to Apply
This is your opportunity to contribute to a groundbreaking facility at the forefront of mRNA therapeutic development. If you're driven by quality and thrive in a fast-paced, innovative environment, we want to hear from you. Click APPLY NOW below or for a confidential discussion, please contact Ruby on 0481200171 at KE Select!
Apply now and be part of something transformative!
KE Select is one of Australia's leading Life Science & Medical Technology recruitment firms. KE Select have established reach throughout ANZ, Asia and the UK and a market presence exceeding ten years. KE Select is quickly becoming the recruiter of choice for many organisations within the Pathology, Life Science, Pharmaceutical, Medical Device and Clinical space.
