GDP Compliance Specialist: Batch Records & Quality

BioSpace; Pearl River (NY); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health and wellbeing benefits

Parental leave

Job summary

Sanofi is seeking a Manufacturing GDP Specialist in Pearl River, NY to ensure the integrity and compliance of manufacturing documentation. You will track, review, and correct batch records and logbooks per GDP and regulatory requirements, coaching shopfloor personnel on GDP principles.

You will partner with Manufacturing Technicians, monitor error-tracking metrics, and support deviation investigations and CAPA, contributing to a culture of quality and compliance across operations.

Qualifications

• High school diploma or equivalent.
• 1+ years in a GMP manufacturing environment.
• Experience with GDP/cGMP and batch records is preferred.

Responsibilities

• Review batch records and logbooks for GDP compliance and regulatory alignment.
• Coordinate with Manufacturing Technicians to ensure timely corrections.
• Support deviation investigations and CAPA development.
• Assist regulatory inspections and internal audits related to documentation.

Skills

GDP principles

GDP (GDP)

cGMP

Batch record review

Deviation investigations

CAPA

Error tracking

Team collaboration

Education

Bachelor's/Associate in science or engineering

High school diploma

Tools

Excel

Electronic batch record systems

Job description

Sanofi is seeking a Manufacturing GDP Specialist in Pearl River, NY to ensure the integrity and compliance of manufacturing documentation. You will track, review, and correct batch records and logbooks per GDP and regulatory requirements, coaching shopfloor personnel on GDP principles.

You will partner with Manufacturing Technicians, monitor error-tracking metrics, and support deviation investigations and CAPA, contributing to a culture of quality and compliance across operations.