GDP Compliance & Batch Records Specialist

Sanofi Group; Pearl River (NY); On-site; USD 70,000 - 95,000; Full time

Job summary

Sanofi Group in Pearl River, NY is seeking a Manufacturing GDP Specialist to ensure GDP-compliant documentation and batch record integrity. You will track, review, and correct batch records and logbooks, coach shopfloor personnel, and escalate GDP issues to safeguard product quality.

Ideal candidates have GMP experience, knowledge of GDP and 21 CFR Parts 210, 211, and hands-on involvement with CAPA and deviation investigations.

Qualifications

• Experience in GMP-regulated manufacturing environments.
• Knowledge of GDP and 21 CFR Parts 210,211.
• Experience with deviation investigations and CAPA processes.
• Familiarity with batch record review and logbook requirements.

Responsibilities

• Track and review batch records and logbooks for GDP compliance.
• Collaborate with technicians to ensure timely corrections.
• Escalate GDP issues affecting safety, efficacy, and quality of drug substance.
• Support regulatory inspections and internal audits related to documentation practices.
• Coach shopfloor personnel on GDP principles.

Skills

GDP knowledge

Error tracking

Coaching shopfloor

Cross-functional collaboration

Detail-oriented

Strong communication

Quality mindset

Education

High school diploma or equivalent

Associate or bachelor's degree in science/engineering

Tools

Electronic batch record systems

Excel

Job description

Sanofi Group in Pearl River, NY is seeking a Manufacturing GDP Specialist to ensure GDP-compliant documentation and batch record integrity. You will track, review, and correct batch records and logbooks, coach shopfloor personnel, and escalate GDP issues to safeguard product quality.

Ideal candidates have GMP experience, knowledge of GDP and 21 CFR Parts 210, 211, and hands-on involvement with CAPA and deviation investigations.