Production Project Coordinator - GMP & Change Control

Fagron Tech; Canton, Northern (MA, KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Opportunity to be part of an expanding

Job summary

Fagron US is seeking a Production Projects Coordinator to support production projects, change controls, and interface with Warehouse, Customer Service, Materials planning/buying, QA and QC to drive completion dates. The role requires strong writing, MS Office proficiency, and experience in FDA‑regulated GMP manufacturing.

You will manage documentation, analyze data for investigations and metrics, and lead cross‑functional meetings to ensure deadlines are met.

Qualifications

• Bachelor's degree in a science field or equivalent experience.
• At least 1 year of experience in an FDA-regulated GMP manufacturing environment.
• Strong writing and communication skills.
• Proficient with MS Office (Word, Excel) and technical writing.

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 organize and lead meetings to ensure deadlines are met.
• Support production transactions and troubleshooting in ERP systems.
• Update, review and approve production documents (batch records, SOPs).
• Gather and analyze data to support investigations and metrics.
• Maintain training requirements and follow SOPs.
• Perform any other tasks assigned by Management.

Skills

Organizational skills

Advanced writing

MS Office proficient

Strong communication

Problem solving

Team collaboration

GMP regulatory knowledge

Education

BA/BS in science (Biology, Microbiology, Chemistry, Pharmacy)

Tools

AX

MasterControl

Job description

Fagron US is seeking a Production Projects Coordinator to support production projects, change controls, and interface with Warehouse, Customer Service, Materials planning/buying, QA and QC to drive completion dates. The role requires strong writing, MS Office proficiency, and experience in FDA‑regulated GMP manufacturing.

You will manage documentation, analyze data for investigations and metrics, and lead cross‑functional meetings to ensure deadlines are met.