QC Specialist

Role overview

CAI is seeking QC professionals in Australia who bring experience across commissioning, qualification, and validation. The role is centered in a pharmaceutical, medical device, or biotechnology environment and supports the establishment and running of quality control activities for a new laboratory operation.

About CAI

CAI is an employee-owned organisation founded in 1996. It has expanded steadily to a global workforce of nearly 700 people. The company delivers commissioning, qualification, validation, start-up, project management, and consulting services that help regulated and mission-critical industries become operationally ready.

Culture and working style

CAI emphasizes a client-first mindset, persistence until work is completed correctly, and a willingness to do what it takes to achieve the right outcome. As an owner-driven company, it is built around principles of integrity, mutual support, service to society, and a shared commitment to the future. Teamwork, respect, and a practical can-do attitude are key parts of the environment.

Employees work alongside subject matter experts and gain exposure to advanced medicine initiatives, including programs connected to life-saving therapies and vaccines. The company also supports professional development through hands-on certifications and training.

Key responsibilities

• Help establish and bring a new QC laboratory into operation.
• Take the lead on, or contribute to, the transfer, qualification, and validation of analytical methods for in-house use.
• Build and follow strong processes for method records and compliance.
• Carry out quality checks on incoming raw materials to confirm they meet specification requirements.
• Perform in-process testing to support manufacturing and scale-up work.
• Complete and document final product testing for batch release support.
• Work with QA to investigate out-of-specification findings and other quality issues.
• Keep GMP documentation accurate, complete, and well maintained.
• Assist in creating SOPs, forms, and testing records.
• Support audits, internal reviews, and improvement efforts.

Requirements

• Practical QC experience in a pharmaceutical, biotechnology, or similar laboratory setting.
• Solid familiarity with laboratory instruments and analytical methods used for raw material and finished product testing.
• Previous exposure to method transfer activities and laboratory setup is strongly preferred.
• Good understanding of GMP, GLP, and related regulatory expectations for QC work.
• Strong focus on detail, structure, and troubleshooting.
• Ability to work independently and stay effective in a fast-paced startup-like environment.

Additional information

CAI uses artificial intelligence tools to assist parts of the hiring process, including resume review, application analysis, and checks for possible inconsistencies or verification signals. These tools support the recruitment team and do not replace human decision-making. Final hiring decisions are made by people. Applicants who want more detail about how data is handled may contact the company directly.