GMP Manufacturing Documentation Consultant

Ridgefield, NJ (100% Onsite)

12-Month Contract

2

$55/hr-65/hour (DOE)

Our client, a leading global pharmaceutical services organization, is seeking two experienced to support a high-profile sterile injectable manufacturing program. This is a long-term onsite consulting opportunity supporting technical transfer activities for commercial pharmaceutical manufacturing.

This position is ideal for professionals with hands-on experience authoring and GMP manufacturing documentation within a sterile injectable or aseptic pharmaceutical environment.

• Author, revise, and maintain GMP manufacturing documentation, including Master Batch Records (MBRs), SOPs, forms, specifications, and logbooks.
• Collaborate with cross-functional Subject Matter Experts (Manufacturing, MSAT, Engineering, Quality, Validation, and Operations) to gather technical information and accurately document manufacturing processes.
• Coordinate document reviews, reconcile reviewer comments, facilitate review meetings, and drive documentation through approval workflows.
• Support documentation throughout engineering, media fill, clinical, PPQ, and commercial manufacturing activities.
• Ensure all documentation complies with cGMP, Good Documentation Practices (GDP), ALCOA+ Data Integrity principles, and internal documentation standards.
• Identify documentation gaps, inconsistencies, and process discrepancies before manufacturing execution.
• Perform advanced document formatting, editing, proofreading, and template management using Microsoft Word.
• Track documentation status, review cycles, approvals, and project milestones while communicating progress and risks to project leadership.

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline (or equivalent industry experience).
• Minimum 5 years of experience supporting GMP pharmaceutical manufacturing.
• Minimum 3 years of experience authoring or revising or Manufacturing Instructions.
• Direct experience supporting .
• Strong understanding of cGMP, Good Documentation Practices (GDP), and ALCOA+ Data Integrity principles.
• Advanced Microsoft Word skills, including complex formatting, templates, styles, tracked changes, tables, pagination, headers/footers, and document management.
• Exceptional proofreading, attention to detail, and technical writing skills.
• Experience supporting technical transfer, process validation, PPQ, or commercial manufacturing documentation is highly preferred.

• Sterile injectable manufacturing
• Aseptic processing
• Technical transfer projects
• Master Batch Record (MBR) development
• Manufacturing Instructions
• Pharmaceutical manufacturing documentation
• Engineering, Clinical, Media Fill, and PPQ campaign support

This is a 100% onsite position in Ridgefield, NJ. Candidates must be able to work onsite Monday through Friday.

If you have a strong background in GMP manufacturing documentation and Master Batch Record authoring within a sterile injectable environment, we'd like to hear from you.



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