CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia.

Experience in the pharmaceutical, medical device or biotechnology industries is required.

Position Description - Assist with the setup and operationalization of the new QC laboratory.

- Lead or support the transfer, validation, and qualification of analytical methods for internal use.
- Implement robust procedures for method documentation and compliance.
- Perform quality testing of incoming raw materials to ensure conformance with specifications.
- Conduct in-process quality assessments to support manufacturing and scale-up activities.
- Execute and document final product testing to support batch release.
- Investigate any out-of-specification results or quality deviations in coordination with QA.
- Maintain high standards of GMP documentation and record-keeping.




- Support the development of Standard Operating Procedures (SOPs), forms, and test records.
- Assist with audits, internal inspections, and continuous improvement initiatives.

Requirements - Prior hands‑on experience in a Quality Control role within a pharmaceutical, biotechnology, or related laboratory setting.

- Strong knowledge of laboratory instrumentation and analytical techniques relevant to raw material and finished product testing.
- Experience with method transfers and laboratory setup is highly desirable.
- Understanding of GMP/GLP and regulatory expectations related to QC.
- Excellent attention to detail, organization, and problem‑solving skills.
- Ability to work autonomously and adapt to a fast‑moving, start‑up style environment.

📌 QC Specialist (City of Sydney)
🏢 Cai
📍 City of Sydney