Company Summary: A mid-sized global pharmaceutical company based near Denver, Colorado focusing on treatments for mental health diseases and addiction. They are currently seeking an experienced QA Auditor focusing on the REMS program to help support ongoing audit commitments, and ensure that the program meets regulatory requirements.
The QA Auditor will be responsible for the following...
- Leading oversight of REMS audits
- Conducting internal audits to access the effectiveness of their REMS QMS and process compliance
- Maintaining the ASL of REMS suppliers
- Supporting quality systems
The QA Auditor will have the following qualifications...
- Bachelor of Science or Bachelor of Arts degree in a life science
- Track record and knowledge of REMS audits and guidelines
- Knowledge of 21 CFR requirements
- CQA or auditing certification preferred
If interested in being submitted, please don't hesitate to apply.
