21 Aug
|
Triton Staffing
|
Williamstown
21 Aug
Triton Staffing
Williamstown
Job Description
Triton Biosensors is a global leader in electrochemical cell technology and biosensor innovation. We manufacture products such as SentiaTM wine testing system (analyzer & test strips) and Xprecia PrimeTM coagulation testing system (analyzers & PT/INR test strips). Our state-of-the-art GMP facility is based in Rowville, Melbourne, and supports the global distribution of products compliant with ISO 13485 and international regulatory frameworks, including TGA, FDA, and EU IVDR.
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Who we are
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Triton Biosensors is a global leader in electrochemical cell technology and biosensor innovation. We manufacture products such as SentiaTM wine testing system (analyzer & test strips) and Xprecia PrimeTM coagulation testing system (analyzers & PT/INR test strips). Our state-of-the-art GMP facility is based in Rowville, Melbourne, and supports the global distribution of products compliant with ISO 13485 and international regulatory frameworks, including TGA, FDA, and EU IVDR.
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About the Role
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We are seeking a Full-time Research Associate to support the activities of our QC lab at Triton Biosensors and execution of scientific investigations within a regulated environment. This role reports to our R&D; Manager and is ideal for someone passionate about research and innovation, with a strong focus on quality and compliance.
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Key Responsibilities
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- Perform routine and non-routine analysis and testing of raw materials, in-process samples, finished products, and stability samples in accordance with approved specifications and procedures, with minimal supervision.
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- Prepare solutions required for production and laboratory testing processes.
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- Set up, operate, calibrate, and maintain laboratory equipment in a cGMP-compliant manner, including completing safety checks and initiating repairs when required.
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- Assist in developing and maintaining procedures for production, calibration,
quality control testing, and batch release activities.
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- Support batch release testing activities, including reviewing test results against acceptance criteria and completing quality records accurately.
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- Investigate out-of-specification and out-of-trend results, support root cause analysis, and assist with CAPA implementation where required.
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- Review QC documentation, including test methods, worksheets, validation records, and batch release documentation.
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- Assist with internal and external audits and support the timely close-out of audit actions.
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- Maintain laboratory equipment, consumables, and supplies while ensuring compliance with GMP, ISO 13485, and ISO 9001 requirements.
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- Support the safe handling, storage, and disposal of chemicals and biological materials.
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- Collaborate with internal teams and provide technical support where required.
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- Ensure laboratory areas are kept clean, tidy, safe, and compliant, with waste disposal managed efficiently and promptly.
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What We're Looking For
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- Degree in a relevant science or engineering discipline.
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- Minimum 2 years' experience in laboratory or research setting.
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- Strong knowledge of scientific principles and statistical analysis.
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- Ability to work with biohazardous substances.
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- Familiarity with QMS requirements and regulatory standards.
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- Excellent problem-solving, organizational, and reporting skills.
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- Strong documentation skills for report and protocol writing.
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- Experience working in a cGMP/GLP setting will be highly regarded.
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Why Join Us?
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At Triton Biosensors, you'll work alongside passionate professionals in a supportive environment that values innovation, safety, and continuous improvement. If you are looking to further your skill set, learn more about blood, wine and water testing in a very impressive GMP facility.... then we are the team for you!
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📌 Research Associate (Williamstown)
🏢 Triton Staffing
📍 Williamstown