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QC Assurance Expert
2 weeks ago
We are seeking a meticulous Quality Assurance Specialist to join our team in Australia.
About the Role:
This pivotal position is ideal for someone passionate about quality and driven to establish in-house assurance capabilities.
The successful candidate will ensure the reliability and consistency of testing practices, collaborating with technical, operations, and QA teams to build our assurance capabilities from the ground up.
Key Responsibilities:
- Implement procedures for method documentation and compliance.
- Perform quality testing of incoming raw materials.
- Conduct in-process quality assessments.
- Troubleshoot and refine assurance workflows.
- Execute and document final product testing for batch release.
- Maintain GMP documentation and records.
- Support SOP development, audits, inspections, and continuous improvement.
Requirements:
- Hands-on experience in a quality assurance role within pharmaceutical, biotech, or related labs.
- Knowledge of laboratory instrumentation and analytical techniques.
- Understanding of GMP/GLP and regulatory standards.
- Attention to detail, organization, and problem-solving skills.
- Ability to work independently in a start-up environment.
What We Offer:
We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness for FDA-regulated and other mission-critical industries. Employees will be exposed to cutting-edge technologies in the advanced medicine space. You will have the opportunity to work with recognized subject matter experts, playing a key role in bringing lifesaving therapies to market.