Manufacturing Project Coordinator I

About this opportunity :

As a Manufacturing Project Coordinator, you will coordinate project related documentation and activities to deliver manufactured API according to prescribed schedules. 

Key Responsibilities:  

• Responsible for the implementation of assigned procedures working within defined schedules. 
• Responsible for performing all work within company and cGMP regulatory compliance. 
• Maintain a safe work environment and following all site safety procedures. 
• Responsible for staying current with the prescribed training curriculum specified for the job title. 

Project Responsibilities: 

• Represent Manufacturing on project related teams, communicating and delivering project expectations. 
• Assist in technical and safety risk assessment and the communication of such risks to the manufacturing team. 
• Write, assist and/or review project specific documentation, including batch records, change controls and automated methods. 
• Assist in the generation and review of MPO’s, BOM’s and other project related technical documents. 
• Assist in technical and safety risk assessment and the communication of such risks to the manufacturing team. 
• Train manufacturing teams on project specific batch records and other batch processing documents. 
• Order and secure project specific raw materials to be used in manufacturing processes. 
• Work with manufacturing Team Leaders to assure operations are performed in compliance with prescribed procedures. 
• Compile, review and communicate project related data to the Production and Project Management teams. 
• Review executed batch records 
• Investigate, author and close project related deviations. 
• Implement and close project specific CAPA’s. 
• Monitor documentation performance and propose solutions for more efficient and improved document performance. 
• Revise generic documentation to keep up with industry standards and customer expectations.