Manufacturing GDP Specialist

(1137) Protein Sciences Corp; Pearl River (NY); Vor Ort; USD 59.000 - 85.000; Vollzeit

Benefits dieser Stelle

Health and wellbeing benefits

Paid parental leave

Rewards package

Zusammenfassung

Sanofi Pearl River, NY is seeking a Manufacturing GDP Specialist responsible for ensuring GDP-compliant documentation by reviewing batch records and logbooks, coaching shopfloor staff, and correlating corrections with regulatory requirements. You will partner with Manufacturing Technicians to safeguard product quality and regulatory compliance across manufacturing operations.

The role emphasizes error tracking, CAPA support, deviation investigations, and collaboration with Quality and

Qualifikationen

• GDP knowledge and regulatory compliance
• Batch record and logbook review
• Error tracking and continuous improvement
• CAPA and deviation investigation support
• Cross-functional collaboration with Manufacturing & Quality
• Strong documentation and attention to detail

Aufgaben

• Track and review manufacturing batch records and logbooks to ensure GDP/regulatory compliance
• Cooperate with Manufacturing Technicians to implement timely corrections
• Maintain error-tracking metrics and identify recurring GDP violations
• Participate in deviation investigations and CAPA creation
• Support regulatory inspections and internal audits of documentation practices
• Collaborate with Quality, Manufacturing, and shopfloor teams to reinforce GDP adherence

Jobbeschreibung

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

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

The salary range for this position is: $58.500,00 - $84.500,00

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.

• 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiliation 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.

Sanofi US endeavours to make our career center accessible to any and all users.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

We are Sanofi Start a career that makes a difference. Reinvention is in our DNA. It’s what drove our evolution from a small French enterprise to one of the world’s leading biopharma companies. Whether it’s using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities.

This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people’s lives.