Document Control Coordinator

• Maintains all document files as related to client NASD and assists in the archival of documents at the offsite storage location
• Issues and reconciles controlled documentation including logbooks, notebooks, controlled forms, batch records, and protocols
• Handles the document lifecycle using the site Training and Document Management System (TMS)
• Plans and executes multiple tasks to ensure controlled documents are prepared on time, managed per procedures, and align with applicable regulations
• Provides training to client personnel on TMS and related processes
• Generates, reviews, and approves labeling materials
• Represents Document Control (DC) in internal meetings, customer interactions, and Regulatory inspections
• Provides support on various other projects or tasks delegated by Document Control Supervisor
• Possesses the ability to evaluate processes, identify efficiencies, and motivate change

Job Qualifications

• High school Diploma or equivalent
• Skill in using computer software and hardware applications, including Microsoft products (Word, Access and Excel) and the Internet
• Prior experience and/or training working in a GMP production environment ​
• Possesses skills in effective communication, written, and verbal
• Ability to use, maintain, and train in the TMS system
• Ability to effectively present information and respond to questions from co-workers, managers, contractors, and customers
• Responsible for managing various projects
• Knowledge of GMP guidelines as well as international conference on harmonization (ICH) regulations pertaining to the production of APIs and drug products