Quality Assurance Associate

4 weeks ago

Melbourne, Australia Canopy Growth Corporation Full time

The Company

At Canopy Growth, our mission is clear: improve lives, end cannabis prohibition, and strengthen communities. We believe that cannabis can be a force for good. We’re building a consumer-centric organization that is focused on sharing the transformational potential of cannabis with the world. We will achieve this through an innovative and disruptive portfolio of cannabis and hemp-derived products.

With millions of square feet of licensed production capacity and operations spanning four continents, Canopy Growth is the world's leading cannabis and hemp company. We recognize that employees are at the core of our success, and we take pride in a corporate culture that emphasizes inclusiveness, collaboration, and diversity.

Our employees come from a wide range of backgrounds, each bringing their own unique skills and talents to the table, working together to continue our incredible momentum of growth. If you are interested in building global challenger brands, scaling a business, and working in a values-driven environment, we want to hear from you

The Opportunity

Canopy Growth is looking for a Quality Assurance Associate/Facilitator to join our team. As a QA Associate, you will be reporting to the Director, Quality Assurance & Regulatory Affairs and will be instrumental in supporting our growth within the ANZ region, ensuring our products exceed expectations. You will engage with a wide variety of stakeholders, sometimes internationally, and enjoy being part of a fast moving, young and evolving medicinal cannabis industry.

**Responsibilities**:
- Collaborate with Quality Control, Regulatory Affairs, Operations, Medical and Marketing departments to ensure compliance with applicable regulations and guidelines of regulatory authorities such as:
- Therapeutic Goods Administration-
- Office of Drug Control-
- State Departments of Health-
- Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables, largely through third party service providers- Collate and investigate reports of product and device quality issues and ensure resolution in accordance with company guidelines and regulatory requirements- Collate and report adverse event reports in accordance with company guidelines and regulatory requirements- Develop or update procedures and databases for capture, investigation, and documentation of product complaints and adverse events- Develop, author and review standard operating procedures and related records and facilitate the same for other departments- Supports the import and distribution of Schedule 4/8 products and raw materials- Assisting in the specification, review and approval of input materials.- Through in-house training become the resident expert in the electronic documentation control system- Prepares and supports management reviews of process performance related to product quality and of the quality management system- Supports, reviews/audits and follows documented procedures to ensure that service providers and outsourced activities are approved and monitored- Escalates issues in a timely manner to the Director of Quality Assurance & Regulatory Affairs- Other duties as required

Experience- Post secondary qualification in a relevant life sciences field with at least 2 years’ experience in a Pharmaceutical or medical device manufacturing environment- Demonstrated understanding of the TGA Code of GMP, PICs Guide and/or ISO14385- Basic knowledge and understanding of Pharmaceutical Quality (i.e. document management, batch release, audits, change control etc), equipment and method validation, sample preparation, analytical techniques & data management- Demonstrated knowledge of Quality Systems as they relate to pharmaceuticals or medical devices

Other Details

This is a part-time to full-time (0.8 - 1.0 FTE negotiable) position based out of our Melbourne office, Australia.

Flexible, hybrid work arrangements are available, but a minimum negotiated attendance in the office will be required.

Some short-term domestic travel should be expected.

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