Sr. Technical Document Specialist

Sr. Technical Document Specialist

Location: NC-Clayton, US Contract Type: Regular Full-Time Area: ADMINISTRATION Req Id: 538439

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

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.

Sr. Technical Document Specialist

The Sr. Technical Documentation Specialist - Label Development is an established, technically competent professional who independently develops and implements solutions for various manufacturing concerns. The Sr. Technical Documentation Specialist - Label Development leads projects of larger scope (or portions of projects) and is often called upon by peers for guidance. The Sr. Technical Documentation Specialist - Label Development coaches and/or facilitates training for other employees. They may supervise employees which also involves managing employee relations matters and conducting performance management reviews. Due to the versatility of this employee's background and competencies, other duties may also be assigned.

Primary Responsibilities for Role

• Coordinate 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.
• Coordinate 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.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton