Supports day to day site compliance needs on the shop floor. Identifies and resolves compliance issues within the Process Unit unilaterally and cross-functionally. Works closely with the Process Units and Quality Organization to ensure compliance...

• Create (from-scratch) and/or significantly rewrite documents including but not limited to design history files, design verification records, and master production records. • Master technical information, organize content, and imbed GxP compliance •...

Supervises QA Documentation Specialist(s), including organizing and prioritizing daily tasks, performing training, and writing performance reviews. Responsible for coordinating all activities related to providing required documentation and...