GDP Compliance & Batch Records Specialist

Sanofi; Pearl River (NY); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Parental leave

Career development

Job summary

Sanofi Pearl River, NY is seeking a Manufacturing GDP Specialist to ensure the integrity and compliance of manufacturing documentation by reviewing batch records and logbooks in line with GDP and regulatory requirements. You will partner with Manufacturing Technicians to drive timely corrections and maintain error-tracking metrics.

The role focuses on safeguarding drug substance quality, supporting batch record simplification, and contributing to deviation investigations and CAPA development.

Qualifications

• GDP and cGMP knowledge is required.
• Experience with GMP manufacturing environments is preferred.
• Familiarity with batch record review and deviation investigations is a plus.

Responsibilities

• Review and correct batch records and logbooks to ensure GDP/regulatory compliance.
• Collaborate with Manufacturing Technicians to ensure timely corrections.
• Identify and escalate GDP issues; participate in CAPA and deviation investigations.

Skills

Attention to detail

Team collaboration

Communication skills

Problem solving

Education

Bachelor's degree in science or related field

Associate degree in science or related field

Tools

Excel

Electronic batch record (EBR) systems

CAPA software

Job description

Sanofi Pearl River, NY is seeking a Manufacturing GDP Specialist to ensure the integrity and compliance of manufacturing documentation by reviewing batch records and logbooks in line with GDP and regulatory requirements. You will partner with Manufacturing Technicians to drive timely corrections and maintain error-tracking metrics.

The role focuses on safeguarding drug substance quality, supporting batch record simplification, and contributing to deviation investigations and CAPA development.