Sr. Technical Document Specialist
NC-Clayton, US
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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. |
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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.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.
Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton