Summary
This position is part of Chemistry, Manufacturing, and Controls (CMC) Documentation and Specifications (CDS) group. The selected candidate will provide support creating workflows and uploading documents on electronic document management system (EDMS) and SharePoint sites on behalf of the CDS group and broader Analytical organization (ASO). Will also provide support in the review of documents authored by CDS group.
Major Duties & Responsibilities:
• Provide support to the CDS group in creating workflows and uploading documents on Electronic Data Management System (EDMS), for example QUMAS, DocMan, etc.
• Provide support to the CDS group in migrating specifications from Veeva to PDLIMS.
• Create and maintain analytical model document templates.
• Completes routine task with little to no supervision; confident in making decision in their subject matter area; able to work proactively. Work with functional area SMEs and support broader team by driving performance and results.
Education/Experience/Knowledge
• Bachelors Degree required in Chemistry
• At least 0-1 years of relevant experience.
• Proficient in Use of Microsoft Office suite (e.g.: Word, Excel, etc.)
• Ability to manage multiple projects simultaneously and on time delivery of required documents.
• Works independently in a team setting and is flexible in a changing environment.
• Good communication and interpersonal skills.
Documentation Analyst • Summit, NJ
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