GMP Production Project Lead (Change Control)

Fagron; Canton (MA); Presencial; USD 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Comprehensive benefits

Performance package

Opportunity to be part of an国际 leader

Descripción de la vacante

Fagron US is seeking a detail-oriented professional to support production projects, drive change controls, and oversee documentation in a GMP environment. You will interface daily with Warehouse, Customer Service, Materials planning, QA, and QC, coordinating both team efforts and independent tasks to ensure on-time project completion.

The role requires strong written communication, advanced MS Office skills, and experience with AX and MasterControl.

Formación

• BA/BS Degree in science field or equivalent combination of education and experience.
• At least one year of experience in an FDA regulated GMP manufacturing environment.
• Advanced writing skills required.

Responsabilidades

• 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.
• Work cross-functionally with other teams within the site to complete projects and monitor deadlines.
• Organize, schedule and facilitate cross-functional team meetings.
• Support production transactions and trouble shooting in ERP systems.
• Update, review and approve production documents such as batch records, SOPs and forms.
• Gather and analyze data to support investigations and metrics.
• Maintain compliance by performing all training requirements on time.
• Follow all applicable Standard Operating Procedures.

Conocimientos

Communication skills

Advanced writing

Organizational skills

Interpersonal skills

MS Office (Word, Excel)

Educación

BA/BS in science field

Herramientas

AX

MasterControl

Descripción del empleo

Fagron US is seeking a detail-oriented professional to support production projects, drive change controls, and oversee documentation in a GMP environment. You will interface daily with Warehouse, Customer Service, Materials planning, QA, and QC, coordinating both team efforts and independent tasks to ensure on-time project completion.

The role requires strong written communication, advanced MS Office skills, and experience with AX and MasterControl.