Documentation Specialist

DOCUMENTATION SPECIALIST WEST POINT, PA Hybrid role requiring at least 2 days a week Onsite . Required Skills:

• Bachelor's Degree in an appropriate scientific or business field of study.
• Minimum of six (6) years' experience in the Pharmaceutical or equivalent industry.
• Strong technical knowledge, skills, and experience in MS Word document editing (e.g., formatting, forms, styles, templates, etc.).
• Microsoft Office experience, SharePoint, Technical writing, editing experience in a GXP environment.
• Excellent verbal and written communication skills as well as presentation skills.
• Strongly developed cross-functional teamwork and collaboration skills.
• Experience directly related to Quality Assurance or Quality Control.
• Experience in the management of Learning Management system (LMS) specifically in the assignment of learning assignments and recording of training completion .

• Serve as document life cycle manager for QMS Quality Standards, Global Procedures and Local Procedures.
• Work closely with the Clinical Supply Learning and Documentation Team to ensure successful implementation of new SOPs, maintenance, and period review of existing SOPs, primarily through the management of document lifecycle (new or existing documents) and review/approval workflows.
• Perform documentation review to ensure consistency (e.g., language, formatting, etc.) within Learning and Documentation team and across the Clinical Supply network.
• Management of assignments of learning roles, processing training rosters and other training evidence to update LMS in a GXP environment.