The client is in need of a QA Compliance Auditor who can virtually run a gap assessment on their departments compliance. This person should be a professional auditor who can see the processes from a compliance perspective. The perfect candidate will be able to look cross functionally at their systems in place and their abilities to follow the procedures. They must also ensure the company has documented evidence that aligns with GMP FDA compliance. They will review product release, batch records, documentation, QMS and the CMO’s documentation that are used for their manufacturing.
- 10 + years of QA Compliance background
- Spending time as a professional auditor
- Gap/ Risk assessment in a biotech atmosphere
- Audit experience within virtual companies
- QA Compliance, Product Release, Batch Record, Documentation, Change Control, QMS
- PLUS: QA Compliance experience within FDA and EU (for future call back position)
Remote: QA Compliance Auditor (233084)