GMP Manufacturing Documentation Specialist

We are looking for an experienced GMP Manufacturing Documentation Specialist to support multiple sterile injectable technology transfer programs within a growing pharmaceutical manufacturing environment. This role is focused on authoring, revising, coordinating, and driving approval of GMP manufacturing documentation, with primary responsibility for Master Batch Records (MBRs) and related controlled manufacturing documents supporting Engineering, Media Simulation, Clinical, and PPQ manufacturing campaigns. This is fully on-site Monday-Friday in Ridgefield, New Jersey.

The ideal candidate will serve as a key partner to cross-functional Subject Matter Experts (SMEs), translating manufacturing processes into compliant GMP documentation while ensuring technical accuracy, document consistency, and timely approvals. This position is best suited for a professional with extensive sterile injectable manufacturing experience, strong GMP documentation expertise, and advanced Microsoft Word capabilities.

Key Responsibilities of the GMP Manufacturing Documentation Specialist:

• Author, revise, and maintain GMP manufacturing documentation including Master Batch Records (MBRs), SOPs, forms, specifications, logbooks, and manufacturing instructions.
• Collaborate with Manufacturing, Process Development, Quality, Validation, and other SMEs to gather and document technical process information.
• Facilitate document review meetings, reconcile reviewer comments, resolve documentation discrepancies, and drive documentation through approval workflows.
• Support documentation throughout Engineering, Media Simulation, Clinical, and PPQ manufacturing campaigns.
• Convert validated manufacturing documentation into commercial Master Batch Records prior to transfer to Manufacturing Operations.
• Ensure documents comply with applicable cGMP requirements, site procedures, Good Documentation Practices (GDP), and ALCOA Data Integrity principles.
• Perform detailed proofreading and quality reviews to identify omissions, inconsistencies, formatting issues, and conflicting process information.
• Track documentation status, review cycles, approvals, and project milestones while providing routine updates to project leadership.
• Proactively identify documentation gaps, missing manufacturing instructions, inconsistent process parameters, and potential GMP documentation concerns, and work with SMEs to resolve them.
  
  

Qualifications of the GMP Manufacturing Documentation Specialist:

• Bachelor’s degree in a scientific, engineering, or related technical discipline, or an equivalent combination of pharmaceutical manufacturing and GMP documentation experience.
• Minimum 5 years of experience supporting sterile injectable pharmaceutical manufacturing operations.
• Minimum 3 years of demonstrated experience authoring and revising GMP Master Batch Records (MBRs) and manufacturing instructions.
• Strong knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and ALCOA Data Integrity principles.
• Advanced proficiency in Microsoft Word, including complex formatting, tables, styles, templates, pagination, headers/footers, document editing, and tracked changes.
• Demonstrated ability to critically review manufacturing documentation, identify technical and procedural gaps, and collaborate with SMEs to resolve issues.
• Exceptional proofreading, organizational, and attention-to-detail skills.
• Experience supporting sterile injectable technology transfer activities preferred.
  
  

Compensation & Benefits for the GMP Manufacturing Documentation Specialist:

• Competitive hourly rate of $65–$85 per hour, commensurate with experience.
• Opportunity to support high-visibility sterile injectable technology transfer and commercialization programs.
• Work alongside cross-functional pharmaceutical manufacturing and technical operations teams.
  
  

Keywords: GMP Documentation, Master Batch Records, MBR Authoring, Sterile Injectables, Technology Transfer, Pharmaceutical Manufacturing, cGMP, GDP, ALCOA , Manufacturing Instructions, PPQ, Aseptic Processing, Technical Writing, Validation Documentation, Microsoft Word

This job opens for applications on 07/19/2026. Applications for this job will be accepted for at least 30 days from the posting date.