GMP QC Lab Specialist — Method Transfer & QA

CAI; Melbourne; On-site; AUD 85,000 - 120,000; Full time

Job summary

CAI is seeking a Quality Control professional to support the setup and operation of a new QC laboratory in Melbourne. The role involves leading or assisting method transfers, validation and qualification for internal use, and implementing robust documentation procedures to ensure compliance with GMP standards.

You will perform raw material testing, in-process assessments, and final product testing to support batch releases, while coordinating with QA on deviations and audits.

Qualifications

• Hands-on QC experience in pharma/biotech lab.
• Knowledge of GMP/GLP and regulatory expectations.
• Experience with method transfers and lab setup.
• Excellent attention to detail and problem solving.

Responsibilities

• Assist with 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 SOPs, forms, and test records.
• Assist with audits, internal inspections, and continuous improvement initiatives.

Skills

Quality Control

GMP

Documentation

Analytical techniques

Tools

Laboratory instrumentation

Method transfers

Job description

CAI is seeking a Quality Control professional to support the setup and operation of a new QC laboratory in Melbourne. The role involves leading or assisting method transfers, validation and qualification for internal use, and implementing robust documentation procedures to ensure compliance with GMP standards.

You will perform raw material testing, in-process assessments, and final product testing to support batch releases, while coordinating with QA on deviations and audits.