- Ensuring all product and processes are in compliance with Regulatory and Quality Systems requirements.
- Audit quality system for GMP/ISO compliance.
- Ensures adequate corrections are implemented on all non-conforming product and that actions are tracked and documented.
- Ensure all non-conformances are adequately bookended.
- Provides training and support to Operations team on Quality/GMP requirements.
- Follow up with Shifts on close out of Operational issues to ensure timely release of product.
- Degree in a Science / Engineering discipline
- 2 Years' Experience in an FDA regulated environment.
- Ability to work in a team environment while meeting daily targets.
