Documentation Specialist III

REQUIRED:
Must have a BS degree
1) Strong technical understanding of general biologics manufacturing unit operations, aseptic processing skills, and the nomenclature utilized in biologics manufacturing (facility, utility and equipment)
(2) Advanced understanding of the Veeva 'One Vault' Quality Documentation Management System
(3) Advanced understanding of documentation change control, documentation processing and administrative tasks with processing a document from draft status to Approved status to Effective status
(4) Advanced understanding of biologics contamination risk, mediation of contamination risk and a background in biologics laboratory &/or manufacturing operations
(5) Technical degree in Chemistry or Biology or Chemical Engineering with 5-10 years of biologics manufacturing experience

Job Description:
Describe the primary goals, objectives or functions or outputs of this position.
Serves as the Subject Matter Expert for documentation support activities including: document formatting, and change request review and approval facilitation.
Responsibilities :
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Facilitates the review and approval of new and revised documents
Maintains document notifications within the document management system
Ensures all administrative documentation requirements are met

Preferred Experience: Knowledge and hands-on experience with Document Management Systems; Experience in detail-intensive and customer-focused environments; Excellent organizational skills, attention to detail, and strong oral and written communications skills; Word processing knowledge and experience with Microsoft Office products