Position Summary: Manage overall batch certification review of sterile and OSD manufacturing/packaging records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, instrument preventive maintenance/calibration/qualification/validation as per good manufacturing practices/good documentation requirements and ALCOA++ principles).

This role will be an individual contributor with expert level experience in manufacturing investigations from FDA approved facilities that make sterile and OSD products. The incumbent will assure individual compliance with all concerned regulatory requirements, GxP’s and applicable department programs, inclu...