Summary:
Author technical documents, review USP changes in a timely manner, and implement changes made to relevant documents
Job Description:
- Writing and reviewing technical documents (method, specifications, validation protocols, validation reports, SOPs)
- Initiating and reviewing change controls for method/specification and SOP revisions
- Evaluate documents and procedures for analytical development and validation
- Issue control copies to the QC department for use
Job Requirements:
- Background in chemistry (qc chemistry, analytical chemistry, etc)
- Experience with wet chemistry analysis and analytical instruments (HPLC, GC, Dissolutions)
- Experience with LIMS, Trackwise, and Document Management System
- Understanding of ICH and FDA regulations to prepare documents
