QC Specialist

CAI; City of 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 Overview

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high‑stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

• We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:

• We act with integrity
• We serve each other
• We serve society
• We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

Requirements include:

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.

Requirement:

• 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.