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Senior Operational Excellence Specialist
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Lead a critical role in ensuring operational integrity and regulatory compliance as a Senior Quality Associate. This position provides ongoing quality support across warehouse and operational functions, guaranteeing adherence to client-specific requirements, industry standards, and internal procedures.
Key Responsibilities- Ensure all warehouse and operational activities comply with established procedures, client expectations, and applicable regulations.
- Investigate, document, and resolve Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Change Controls in a timely manner.
- Communicate effectively with customers regarding quality matters, providing clear and professional updates.
- Oversee the integrity of processes and systems, including SAS release, controlled destruction, and return to vendor sessions.
- Maintain training records and labelling processes, ensuring they are compliant and up-to-date.
- Track and trend quality key performance indicators (KPIs) and metrics to drive continuous improvement.
- Strong knowledge of ISO 13485 principles and experience applying them in a healthcare, medical device, or pharmaceutical environment.
- Comprehensive understanding of TGA regulations, PIC/S Code of GMP, and GWP.
- Familiarity with integrating ISO 9001 into a quality management system.
- Basic understanding of supply chain management and integrated logistics.
- Prior experience working in or with a logistics site is highly advantageous.
To excel in this role, you will need to demonstrate a passion for progress and a willingness to learn. As part of a collaborative and supportive team, you will have the autonomy to make decisions that drive meaningful impact. Develop your skills through industry-leading training and grow with talented experts.
