Quality Assurance Associate

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Founded in 1975, IDT Australia is a publicly listed Australian pharmaceutical manufacturing company based in Boronia, Victoria. Our experienced team of scientists and specialists provide flexible and comprehensive services with a focus on Active Pharmaceutical Ingredient synthesis, Specialty Orals for neuro disorders, and Advanced Technology for injectable drug development. IDT Australia operates a fully equipped laboratory approved to TGA and FDA standards for GLP analytics, and also specializes in clinical trial labelling and packaging.

Role Description

This is a full-time, on-site role located in Boronia, VIC for a Quality Assurance Associate. The core purpose of the QA Associate is to provide client partnership, advice and execution of the Quality Excellence framework for IDT. This will be achieved through partnering with clients to be an In Process and On-the-Floor Quality champion for the adoption of Quality Excellence activities as they pertain to adopting practices to achieve Right First Time and Zero Defect culture and organisation performance.

The QA Associate is a key partner in helping transition from a reactive lag measure Quality System to a proactive lead measure focused preventative built-in Quality focus to drive down Deviations and CAPAs and overdue Quality Metrics. The role partners with internal clients to help them build on their Quality Culture and improvements to build a Right First Time and Zero-Defect culture.

The Associate will achieve this through supporting Quality activity in process in real time with the client in situ to create better workflows and better customer delivery on critical activities, particularly related to Batch Release. The Quality Associate is a champion in helping ensure the right Quality focus and measures are applied to ensure IDT delivers on its Customer, Quality, and Cost commitments.

Qualifications

Minimum requirement for this position is a Science or Chemical Engineering degree or relevant discipline.

LEAN or Six Sigma certified will also be very well regarded.

• 5+ years experience in the Pharmaceutical or Biotech industry with a demonstrated Operations, Process Development / Validation, and Quality background through cGMP stages for development, clinical, and commercial manufacturing. Preferably with Sterile and Aseptic practice environments.
• Solid understanding and experience with Pharmaceutical Quality regulatory standards, codes, and industry standards to apply to Quality systems and frameworks.
• Systems thinking, LEAN principles, and Operations Excellence experience to support Right First Time, Zero Defects, In-Process Quality, eQMS, and Quality Transformation initiatives.
• Experience with sterile processes, knowledge, and capability to design Quality system processes to meet industry standards for aseptic filling, freeze drying, formulation, and packaging.
• Proven ability to apply key cGMP, Quality, Validation, Scientific, and Testing processes to ensure effective manufacturing and process control.
• Ability to influence, negotiate, and collaborate with all organizational levels and external partners to promote Quality practices and adoption.
• Strong interpersonal skills to consult, advise, and partner with client groups, providing real-time Quality guidance on the floor.
• Lateral thinking skills to adapt Quality applications appropriately across research, development, and manufacturing contexts.
• Analytical skills to analyze data, identify trends, and perform root cause analysis for problem-solving and decision-making.

Applicants must

• Have full working rights in Australia
• Be located in Melbourne for immediate start
• Complete police check and employment medical as part of the onboarding process