Entry-Level QA Generalist - cGMP Pharma

Fagron Nederland BV; Canton (MA); Presencial; USD 55.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits

Performance package

Descripción de la vacante

Fagron North America is seeking an entry-level Quality Assurance Generalist to support cGMP manufacturing and documentation for compounded products. You will help ensure controls are followed during manufacturing, processing, packaging, and warehousing activities.

The role requires a college degree or equivalent with cGMP exposure, familiarity with MasterControl, and strong MS Office skills. A fast-paced environment and teamwork are essential as you contribute to compliant operations and quality

Formación

• College degree or high school diploma with cGMP experience in pharmaceutical manufacturing is required.
• Experience with aseptic technique and cGMP document review is preferred.
• Proficient in MS Office (Word, Excel) and able to work in a fast-paced environment.

Responsabilidades

• Support execution of batch records and manufacturing QA systems for compounding processes.
• Ensure day-to-day compliance with all requirements for compounded products and supporting systems.
• Assist with problem identification and resolution for quality-related issues in compounding operations.
• Review and approve manufacturing batch records, labels and related documentation.
• Assist with internal and external inspections and audits.
• Provide input on quality system effectiveness metrics such as right-the-first-time and documentation accuracy.
• Participate in QA meetings for product manufacturing and media fill execution.
• Maintain cGMP documentation and standard operating procedures.

Conocimientos

Attention to detail

MS Office proficiency

Quality mindset

Team collaboration

Educación

College degree or high school diploma with cGMP experience

Herramientas

MasterControl

Descripción del empleo

Fagron North America is seeking an entry-level Quality Assurance Generalist to support cGMP manufacturing and documentation for compounded products. You will help ensure controls are followed during manufacturing, processing, packaging, and warehousing activities.

The role requires a college degree or equivalent with cGMP exposure, familiarity with MasterControl, and strong MS Office skills. A fast-paced environment and teamwork are essential as you contribute to compliant operations and quality