**Job Summary**

Manage overall batch 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.

**Area Of Responsibility**

+ Subject matter expert (SME) understanding of sterile manufacturing and packaging.
+ Leads the review of sterile and OSD manufacturing/packaging records from a Global Quality perspective.
+ QA SME for manufacturing (Sterile & OSD), environmental monitoring, microbiology, media-fill & packaging Investigations and related CAPAs.
+ Successful experience with FDA inspections
+ Ensure...