Production Projects Specialist - GxP & Change Control

Fagron Sterile Services US (FSS); Canton (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Fagron Sterile Services US (FSS) in Canton, MA, seeks a Production Projects Coordinator to support production projects, change controls, and driving completion dates. You will work with Warehouse, Customer Service, Materials Planning, QA and QC, communicating across levels and leading meetings to resolve issues.

The role requires strong writing, proficiency with MS Office, Excel, and ERP knowledge. You will update documents, review batch records, and ensure compliance with GMP and FDA

Qualifications

• BA/BS Degree in science field (e.g., Biology, Microbiology, Chemistry, Pharmacy) or equivalent.
• At least 1 year experience in an FDA-regulated, GMP manufacturing environment.
• Advanced writing skills and strong organizational abilities.
• Proficiency with MS Office (Word, Excel) and ERP systems.
• Strong interpersonal, written and verbal communication skills.

Responsibilities

• Be the primary contact for projects or activities that occur in support of production.
• Maintain offline planning tools and analysis.
• Support the manufacturing production team and leadership in driving projects to completion.
• Assess processes for change management and generate change controls with appropriate actions.
• Cross-functionally collaborate to complete projects while maintaining deadlines.

Skills

Project management

Cross-functional leadership

Written communication

Data analysis

MS Office (Excel/Word)

GxP compliance

Education

BA/BS in science

Tools

AX

MasterControl

Job description

Fagron Sterile Services US (FSS) in Canton, MA, seeks a Production Projects Coordinator to support production projects, change controls, and driving completion dates. You will work with Warehouse, Customer Service, Materials Planning, QA and QC, communicating across levels and leading meetings to resolve issues.

The role requires strong writing, proficiency with MS Office, Excel, and ERP knowledge. You will update documents, review batch records, and ensure compliance with GMP and FDA