Quality Control Specialist

23 hours ago

Sydney, New South Wales, Australia Cai Full time

CAI is looking for individuals with a range of experience in the areas of commissioning, qualification, and validation to join our team in Australia.
Experience in the pharmaceutical, medical device, or biotechnology industries is required.About CAI:CAI is a 100% employee-owned company established in 1996, with over 800 employees worldwide.
We provide commissioning, qualification, validation, start-up, project management, and consulting services related to operational readiness for FDA-regulated and other mission-critical industries.Are You Ready?
Our approach is simple: we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.As owners of CAI, we are committed to living our Foundational Principles:We act with integrityWe serve each otherWe serve societyWe work for our futureWith employee ownership, one person's success is everyone's success; we work diligently to accomplish team goals.
We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude.
That is how we have grown exponentially.CAI employees will be exposed to cutting-edge technologies in the advanced medicine space.
You will have the opportunity to work with recognized subject matter experts, playing a key role in bringing lifesaving therapies to market, including COVID-19 vaccines and therapies.
We invest in your future through certifications and professional training.
Our collaborative culture ensures exemplary work across our professional services.About the RoleWe are seeking a hands-on, experienced Quality Control (QC) Specialist to support our rapidly evolving laboratory operations.
This pivotal role is ideal for someone passionate about quality, thriving in a fast-paced environment, and ready to establish in-house QC capabilities.As we set up our lab infrastructure and transition analytical methods internally, the successful candidate will ensure the reliability and consistency of testing practices.
You will collaborate with technical, operations, and QA teams to build our QC capabilities from the ground up.Work Location: Sydney, AustraliaEmployment Type: 6 monthsStart Date: ImmediateRequirements include: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 procedures for method documentation and compliance.Perform quality testing of incoming raw materials.Conduct in-process quality assessments.Troubleshoot and refine QC workflows.Execute and document final product testing for batch release.Investigate out-of-specification results or deviations with QA.Maintain GMP documentation and records.Support SOP development, audits, inspections, and continuous improvement.Position Requirements:Hands-on experience in a QC role within pharmaceutical, biotech, or related labs.Knowledge of laboratory instrumentation and analytical techniques.Experience with method transfers and lab setup is desirable.Understanding of GMP/GLP and regulatory standards.Attention to detail, organization, and problem-solving skills.Ability to work independently in a start-up environment.Why Join Us?
Opportunity to shape our internal QC capabilities from day one.Collaborative and dynamic team culture.Exposure to diverse projects and cutting-edge developments.Flexibility and autonomy in your work style.
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