GDP Compliance Specialist - Manufacturing Quality

Sanofi Group; Jersey City (NJ); On-site; USD 70,000 - 100,000; Full time

Job summary

Sanofi Inc. in Pearl River, NY seeks a Manufacturing GDP Specialist to secure documentation integrity by reviewing batch records and logbooks per GDP and applicable regulatory requirements.

You will work closely with Manufacturing Technicians to drive timely corrections and coach shopfloor personnel on GDP principles. You will identify GDP issues affecting safety, efficacy, and quality, participate in deviation investigations and CAPA creation, and support regulatory inspections and internal

Qualifications

• Experience ensuring GDP and regulatory compliance in manufacturing.
• Ability to review batch records and logbooks rigorously.
• Familiarity with deviation investigations and CAPA processes.

Responsibilities

• Track and review batch records and logbooks for GDP compliance.
• Maintain and improve error-tracking metrics to reduce repeats.
• Escalate GDP issues affecting product safety and quality.
• Collaborate with Manufacturing, Quality, and shopfloor teams.

Skills

GDP knowledge

cGMP regulations

Documentation review

Analytical mindset

Education

Associate or Bachelor's degree in science/engineering

Tools

Electronic Batch Records (EBR) systems

Job description

Sanofi Inc. in Pearl River, NY seeks a Manufacturing GDP Specialist to secure documentation integrity by reviewing batch records and logbooks per GDP and applicable regulatory requirements.

You will work closely with Manufacturing Technicians to drive timely corrections and coach shopfloor personnel on GDP principles. You will identify GDP issues affecting safety, efficacy, and quality, participate in deviation investigations and CAPA creation, and support regulatory inspections and internal