Documentation Specialist - sterile injectable

Job Description

Job Description

Position: Documentation Specialist

Location: Ridgefield, NJ

Duration: 6/12+ Months

Job Description

Our client is seeking a GMP Manufacturing Documentation Specialist to support several technical transfer initiatives involving sterile injectable pharmaceutical products. This consultant will develop, update, and manage controlled manufacturing documents, with a primary focus on Master Batch Records (MBRs) and related controlled manufacturing documents.

The specialist will work closely with cross-functional Subject Matter Experts (SMEs) to gather technical information, translate manufacturing processes into compliant manufacturing documentation, coordinate document reviews, reconcile reviewer comments, facilitate review meetings, and drive the approval process. Documentation support will span the technical transfer lifecycle, including Engineering, Media Simulation, Clinical, and Process Performance Qualification (PPQ) manufacturing campaigns. Following validation activities, the consultant will prepare and finalize commercial Master Batch Records for transfer to Manufacturing Operations.

The ideal candidate combines hands-on knowledge of sterile injectable manufacturing with strong GMP documentation experience, advanced Microsoft Word capabilities, and the ability to recognize documentation gaps or process inconsistencies before they affect manufacturing execution.

Day-to-Day Responsibilities

• Author and revise GMP Master Batch Records and other controlled manufacturing documents supporting sterile injectable technical transfer projects.
• Adapt approved site templates and existing documentation to reflect product-specific manufacturing processes.
• Partner with SMEs from Manufacturing, Process Development, Technical Operations, Quality, Validation, and other functions to obtain and confirm technical content.
• Translate complex manufacturing processes into clear, executable, and compliant manufacturing instructions.
• Manage document review cycles, incorporate reviewer feedback, reconcile comments, and facilitate review meetings when alignment is needed.
• Identify missing instructions, inconsistent process parameters, conflicting technical details, and other documentation concerns.
• Drive assigned documents through revision, approval, and document control workflows until they are ready for implementation.
• Update documentation for Engineering, Media Simulation, Clinical, and PPQ manufacturing campaigns.
• Convert validated campaign documentation into commercial Master Batch Records before handoff to Manufacturing Operations.
• Format and proofread controlled documents for accuracy, consistency, readability, and compliance with site documentation standards.
• Maintain documentation trackers covering document ownership, review status, approval progress, responsible reviewers, target dates, and outstanding actions.
• Provide routine progress updates and promptly escalate issues that could affect technical transfer or manufacturing timelines.
• Support additional controlled documents, including SOPs, forms, specifications, and logbooks, as required.

Must-Have Skills

• Bachelor’s degree in a scientific, engineering, or related technical discipline, or an equivalent combination of pharmaceutical manufacturing and GMP documentation experience.
• At least five years of experience supporting sterile injectable pharmaceutical manufacturing operations.
• At least three years of direct experience authoring or revising GMP Master Batch Records (Manufacturing Instructions.)
• Strong understanding of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and ALCOA+ Data Integrity principles.
• Advanced Microsoft Word proficiency, including complex document formatting, document styles, templates, section formatting, pagination, headers and footers, revision histories, tracked changes, and detailed editing.
• Demonstrated ability to critically evaluate manufacturing documents and identify omissions, inconsistencies, conflicting process information, formatting errors, and GMP documentation risks.
• Exceptional attention to detail, proofreading ability, and document quality standards.
• Ability to manage multiple documents, reviewers, deadlines, and approval cycles in a project-driven environment.