Project Coordinator, Documentation Associate

About this opportunity :

The purpose of this position is to support documentation and data collection activities for the Project coordinator group and Manufacturing department.  The position is responsible for supporting PC and MFG with general tasks, documentation, Batch verification and batch record review. 

Key Responsibilities: 

• Review Process Instructions after manufacturing execution and update where needed.
• Originate and/or revise CGMP documentation including but not limited to Process Instructions, MPBRs, Protocols, SOP’s, and Process Instructions
• Scan and file relevant training forms for the Manufacturing department.
• Provide any requisite administrative support to Project coordinators and Manufacturing department
• Ensure that digital repositories are maintained including scanning and filing of manufacturing documentation
• Collect manufacturing data (ex: batch record data, batch verification, batch record review, raw material data etc.) as requested by management or project teams
• Complete tasks in SAP system to support PC team
• Interact with various functional groups to accomplish project goals
• Other duties as assigned. 

Required Skills/Abilities:

• High school diploma or equivalent
• 2-5 years’ experience in an administrative role or equivalent
• Knowledge of Microsoft Office Suite (Word, Excel and PowerPoint)
• Must be proficient with advanced Excel and Word functionality.
• Interpersonal, time management, and organizational skills
• Ability to work independently, take initiative, and respond to rapidly changing priorities