QC Lab & Methods Validation Specialist

Caiready; City of Melbourne; On-site; AUD 65,000 - 95,000; Full time

Job summary

CAI is seeking a QC Laboratory professional to assist with the setup and operationalization of the new QC laboratory, and to lead or support the transfer, validation, and qualification of analytical methods for internal use.

The role focuses on implementing robust GMP documentation, performing quality testing of incoming raw materials, conducting in-process quality assessments, and supporting batch release testing and continuous improvement initiatives.

Responsibilities

• 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.

Job description

CAI is seeking a QC Laboratory professional to assist with the setup and operationalization of the new QC laboratory, and to lead or support the transfer, validation, and qualification of analytical methods for internal use.

The role focuses on implementing robust GMP documentation, performing quality testing of incoming raw materials, conducting in-process quality assessments, and supporting batch release testing and continuous improvement initiatives.