Website Lenox Executive Search
REMOTE – 1 year contract – likely to extend
The QC reviewer will have a primary responsibility of reviewing analytical data packages from external CMO’s and be able to communicate and escalate technical findings to the team. This role will also have the responsibility of managing commercial analytical documentations and change controls, such as methods and specifications revisions, writing analytical reports, etc. The QC reviewer will have the opportunity to work on continuous improvement process in analytical methods performance trending as well.
To be successful in this role, the candidate must have knowledge in common analytical techniques (e.g. HPLC, KF, GC, dissolution, etc.) and in GMP documentation review. The candidate should also have demonstrated communication skills.
- Review release and stability testing analytical data packages
- Documentation specialist (managing internal and external analytical documents)
- Change control ownership
- Analytical methods performance trending
- BS with 2+ years relevant work experience
- Knowledge of cGMP’s
- Knowledge in HPLC
- Must be a committed team player and collaborator