Senior Quality Assurance Associate

Benefits

The opportunity to be a Senior Quality Assurance Associate at Cyclopharm has become available. You will have the unique opportunity to gain experience within Quality Assurance at a company on the cusp of joining overseas markets with their ground-breaking medical innovations.

About the company

With over 30 years' experience in research and design, Cyclopharm brings an innovative and niche radiopharmaceutical product to the healthcare industry. Cyclopharm are driven by enhancing and developing medical innovations for diagnostic imaging, specialising in lung health. This is an exciting time to join the organisation as they embark on obtaining new market share and enhancements of their products.

About the opportunity

As a Sydney based Senior Quality Assurance Associate, the role will be on-site. The company is based in Kingsgrove, South Sydney which is within 15km of the CBD. This position is to provide support to the Quality & Regulatory teams to ensure products manufactured meet the highest levels of quality and compliance.

Duties

• Documentation control and assist with managing quality systems
• Write and review SOPs and Work Instructions
• Investigate and manage non-conformances, CAPAs, deviations and complaints
• Support with audit findings and management
• Cross functional support of design and manufacturing teams from a Quality perspective
• Conduct routine QA duties such as issue and review of batch documentation and release
• Encourage an 'audit-readiness' culture
• Ensure compliance and adherence to applicable GMP and regulatory guidelines

Skills and Experience

• Tertiary qualification in Science, Engineering, or relevant discipline
• Experience in Quality Assurance in a GMP environment for medical devices, pharmaceuticals, or related field
• Thorough knowledge of standards and governing bodies
• Clear and effective verbal and written communication skills
• High attention to detail with ability to problem solve

Culture

Collaborative team environment. Company values integrity and quality whilst manufacturing and developing innovative technologies.

How to Apply

Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.