Electronic Documentations Specialist

Job Description

Job Summary:

• This opportunity will support the documentation control and management of the CSO functional areas by coordinating activities related to GxP/GMP documentation system and administrating associated controlled documents and their processes to ensure compliance.

Duties and Responsibilities:

• Serve as a Document Control liaison on documentation managed through the electronic management system.
• Assists with maintenance and administration of procedures related to job function.
• Ensures that documentation complies with established documentation system process and requirements.
• Management of controlled procedural documents throughout their lifecycle.
• Understand the correct use of controlled procedural documents types.
• Able to write, review, edit, and circulate documents with clarity and brevity.
• Adhere to documentation requirements.
• Demonstrate excellence in writing clear, good grammar and punctuation practices as well as attention to detail with concise business-related documents.
• Possess confidence and poise to collaborate with a diverse working population.
• Able to multi-task in a dynamic, challenging environment.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Communicates effectively with all cross functional and regional stakeholders on matters related to documentation.

Qualifications:

• Master’s degree (will be overqualified).
• High school diploma, associate degree, or bachelor’s degree acceptable.
• College or university degree preferred.
• Experience with GMP and regulatory documents preferred.
• Experience with clinical trial documentation acceptable, though GMP experience is highly preferred.
• Familiarity with document lifecycle management.
• Proficiency in Microsoft Office programs.