Sr. Technical Document Specialist

Overview

The Sr. Technical Document Specialist - Label Development provides label development support to create new and revised labeling components to meet market timelines. This includes labeling for Grifols Therapeutic components used at both the Clayton site and at other Grifols sites that are licensed to package Grifols Therapeutics products. Internal customers include Regulatory Affairs, Supply Chain, Manufacturing, Quality, Engineering, and Commercial.

Primary responsibilities for role

• Cook up the creation/revision of labeling components with external typesetters, review typeset mockups, obtain appropriate approvals, review/approve vendor print proofs and work with Supply Chain partners to maintain labeling implementation timelines.
• Review labeling components and associated documentation for completeness and accuracy.
• Maintain internal Label Development electronic files using Microsoft Word, Microsoft Excel, Open Site Master and WebCenter software. This includes shipper, pallet, supplemental and barcode print files that are developed and approved internally.
• Communicate effectively with internal customers and external vendors, including typesetters and print vendors.
• Maintain labeling history documentation.
• Cook up larger and overlapping labeling projects.
• Perform other duties as required.

Knowledge, skills & abilities

• Must be able to communicate effectively at all levels.
• Must demonstrate strong technical and/or regulatory expertise and ability to adapt to changing circumstances.

Requirements

• BS/BA degree in a relevant field and 6 years of related experience. An equivalent combination of education and experience may be considered.