Manufacturing GDP Specialist

Job Title: Manufacturing GDP Specialist Location: Pearl River, NY   About the Job: Ensures the integrity and compliance of manufacturing documentation by tracking, reviewing, and correcting batch records and logbooks in accordance with Good Documentation Practices (GDP) and applicable regulatory requirements. Partners closely with Manufacturing Technicians to drive timely error correction, maintains error tracking metrics to identify and resolve repeated GDP violations, and coaches shopfloor personnel on GDP principles. Plays a key role in safeguarding the safety, efficacy, and quality of drug substance by identifying and escalating GDP-related issues, supporting batch record simplification efforts, and contributing to deviation investigations and CAPA development.   This role is accountable for documentation accuracy, batch record review cycle time, and fostering a culture of quality and compliance across manufacturing operations.   Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.   About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives. Main Responsibilities: Batch Record & Logbook Review • Track and review manufacturing batch records and logbooks to ensure compliance with GDP and regulatory requirements • Follow up with Manufacturing Technicians to ensure corrections are completed in a timely manner • Ensure batch record review cycle time targets are consistently met   Error Tracking & Continuous Improvement • Maintain error tracking metrics to identify, address, and correct repeated violations of GDP • Review batch record structure and recommend simplifications to minimize errors, as applicable • Coach shopfloor technicians on GDP principles and best practices   Quality & Compliance Escalation • Identify and escalate GDP issues that could affect the safety, efficacy, and quality of drug substance • Participate in deviation investigations and CAPA (Corrective and Preventive Action) creation, as applicable • Support regulatory inspections and internal audits related to documentation practices   Team Collaboration • Collaborate cross-functionally with Manufacturing, Quality, and shopfloor teams • Serve as a key point of contact for GDP-related questions and guidance on the shopfloor     Physical Requirements • Ability to work in a manufacturing environment, including cleanroom gowning requirements • Regular walking and standing during shopfloor reviews and interactions with Manufacturing Technicians • Occasional lifting up to 25 lbs • Flexibility to respond to documentation or compliance issues outside of standard business hours, as needed About You: Basic Qualifications • High school diploma or equivalent. • 1+ years of experience in a GMP regulated manufacturing environment.   Preferred Qualifications • Associate or bachelor's degree in a science, engineering, or related field • Prior experience in biopharmaceutical, pharmaceutical, or vaccine, biologics, or equivalent industries. • Exposure to electronic batch record (EBR) systems • Lean Manufacturing or continuous improvement training Technical Skills • Working knowledge of Good Documentation Practices (GDP) and cGMP regulations (21 CFR Parts 210, 211) • Familiarity with batch record review and manufacturing logbook requirements • Understanding of deviation investigation and CAP