Advanced Quality Analyst

3 weeks ago

Lane Cove, Australia Beckman Coulter Diagnostics Full time

Beckman Coulter is a global provider of biomedical testing systems and related products that simplify and automate laboratory processes. The company's instruments and chemistries are used in all areas of the biomedical testing continuum: patient care, translational solutions, and research and development. From complex DNA sequencing to simple one-use diagnostic screening kits, Beckman Coulter's products are utilised in every phase of the battle against disease.

Beckman Coulter Diagnostics includes over 10,000 associates who serve the $41 billion Clinical Diagnostics market. We deliver more than 250 million tests every year, used by doctors to diagnose, treat, monitor and manage their patients. Our tests help diagnose diseases such as prostate cancer, colorectal cancer, leukemia, HIV, congestive heart failure and heart attacks. Beckman Coulter is an operating company of Danaher Corporation and is an equal opportunity employer.

**Job Summary**:
The Advanced Quality Analyst inspects and reports on manufacturing quality. The incumbent inspects incoming materials, packaging and labelling components, work-in-process and/or final products; may handle intricate First Article inspections on reagents, compounds or assemblies to approve operator set-ups for production; initiate rejection reports for non-conforming materials; create and analyse quality reports, recommending quality improvement actions; interface with internal customers and suppliers to troubleshoot and resolve quality issues.

**Responsibilities**:
Overall accountability of the production testing and validation workflow and responsible for ensuring all documentation is up-to-date and training is provided to stakeholders
Executing on testing and validation of all production processes
Design process to be fail safe and reproduceable and ensure quality control process is ready for final release testing
Implement and monitor production and quality processes to assess functionality, reliability, performance, and quality of the product.
Identify and remedy defects within the production process.
Recommend, implement, and monitor preventative and corrective actions to ensure that quality assurance standards are achieved.
Compile and analyse statistical data to identify trends or areas for improvement
Ensure that user expectations are met during the testing process.
Draft quality assurance policies and procedures.
Investigate customer complaints and product issues.
Ensure ongoing compliance with quality and industry regulatory requirements.
Review and approve planned deviations and plans for re-processing.
Participate in external and internal audits. Ensure that internal audit findings are closed in a timely manner.
Support and build working relationships with cross-functional teams including Manufacturing, Supply Chain, Regulatory Affairs etc, to ensure process solutions are aligned according to regulatory standards.
Provide continuous assessment of the Quality Management System
Responsible for procurement and inventory planning, and managing Supplier relationships and evaluations
Adheres to policies and procedures
Drive continuous improvement and acts as a local champion for Danaher Business System (DBS) Fundamentals.

**Job Requirements**:
Equivalent of 3+ years of experience in a regulated manufacturing environment (ISO 9000 & 13485 and GLP/GMP concepts)
Bachelor’s degree or equivalent experience is required, preferably in Science
A good working knowledge of Lean and or six sigma techniques would be an advantage.
Experience with MS Office word processing and Excel Spreadsheets
High degree of self-motivation and ability to work autonomously to drive results
Excellent communication skills, strong knowledge of global regulatory and compliance requirements, able to meet deadlines and deliver on critical plans, teamwork oriented, results and process driven.
High attention to detail and strong analytical skills
Ability to work to tight deadlines and proven organisational skills
Experience with Oracle or similar Inventory Management databases is preferred
Unrestricted Australian/New Zealand working rights

Our quality management systems are at the core of the how Beckman Coulter operates, improves and maintains compliance. Along with DBS skills, you will be required to work closely with local/regional management and operational teams to leverage the QMS to drive continuous improvement.

Working at Beckman Coulter, you’ll join a team of collaborative and inventive people. We are resourceful, tenacious and have an appetite for winning We value honesty and courage and strive for excellence and innovation. We have a genuine desire to do the right thing - always.

We work in a fluid environment in which flexible responses and accommodating change on a regular basis is important. You’ll find a framework of large, inter-disciplinary teams that stretch beyond the traditional boundaries of time and geography.

We’re a growing company, and part of Danaher - a glo

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