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.
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Position Description
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- Assist with the setup and operationalization of the new QC laboratory.
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- Lead or support the transfer, validation, and qualification of analytical methods for internal use.
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- Implement robust procedures for method documentation and compliance.
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- Perform quality testing of incoming raw materials to ensure conformance with specifications.
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- Conduct in-process quality assessments to support manufacturing and scale-up activities.
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- Execute and document final product testing to support batch release.
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- Investigate any out-of-specification results or quality deviations in coordination with QA.
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- Maintain high standards of GMP documentation and record-keeping.
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- Support the development of Standard Operating Procedures (SOPs), forms, and test records.
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- Assist with audits, internal inspections, and continuous improvement initiatives.
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Requirements
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- Prior hands‐on experience in a Quality Control role within a pharmaceutical, biotechnology, or related laboratory environment.
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- Strong knowledge of laboratory instrumentation and analytical techniques relevant to raw material and finished product testing.
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- Experience with method transfers and laboratory setup is highly desirable.
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- Understanding of GMP/GLP and regulatory expectations related to QC.
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- Excellent attention to detail, organization, and problem‐solving skills.
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- Ability to work autonomously and adapt to a rapid‐moving, start‐up style environment.
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📌 QC Specialist (New South Wales)
🏢 Cai
📍 New South Wales
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