Technical Writer Job at Katalyst Healthcares and Life Sciences in Exton

Responsibilities :

• uthor technical reports, policies, and Standard Operating Procedures.
• uthor / review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
• uthor investigations, deviations, change controls, and other non-conformance records.
• Work with vendors to coordinate testing and arrange shipments as needed.
• Compile and review scientific data for completeness as needed.
• Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
• Use of LIMS database including protocol setup, data entry / approval, and data trending.
• Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.
• Coordinate document review, approval, and archiving.
• Participate in analytical testing lab activities, on an as needed basis.

Requirements :