QC Specialist: Lab Setup, Method Transfer & GMP

Cagents; City of Melbourne; On-site; AUD 70,000 - 110,000; Full time

Job summary

CAI is expanding its Quality Control capabilities in Melbourne to support pharmaceutical and biotech clients. We seek a hands-on QC professional to help setup and operate a new QC laboratory, perform analytical testing, and ensure strict GMP documentation for batch release.

The role requires autonomy in a fast-moving startup environment and collaboration with QA for deviations and improvements. The successful candidate will contribute to method validation/transfer, instrument-based testing, and

Qualifications

• Prior hands-on experience in a Quality Control role within a pharmaceutical, biotechnology, or related laboratory environment.
• 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.

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.

Skills

Quality Control

Analytical techniques

Attention to detail

Autonomous work style

Problem-solving

Tools

Laboratory instrumentation

Method transfers

Job description

CAI is expanding its Quality Control capabilities in Melbourne to support pharmaceutical and biotech clients. We seek a hands-on QC professional to help setup and operate a new QC laboratory, perform analytical testing, and ensure strict GMP documentation for batch release.

The role requires autonomy in a fast-moving startup environment and collaboration with QA for deviations and improvements. The successful candidate will contribute to method validation/transfer, instrument-based testing, and