Manufacturing GDP Specialist

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

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.

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

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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 elevate 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 CAPA processes, a plus
• Basic knowledge of error tracking and metrics reporting tools (e.g., Excel, electronic batch record systems), a plus.

Soft Skills

• Highly detail-oriented with the ability to work quickly and accurately
• Sound interpersonal and information-gathering skills
• Ability to work effectively in a team environment and interact with others across all levels
• Strong written and verbal communication skills
• Proactive, quality-focused mindset
• Demonstrated attention to detail and accuracy in documentation-focused tasks
• Ability to work quickly and accurately under time constraints

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiant employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.