GMP Manufacturing Documentation Consultant
Location: Ridgefield, NJ (100% Onsite)
Duration: 12-Month Contract
Openings: 2
Pay Rate: $55/hr-65/hour (DOE)
Our client, a leading global pharmaceutical services organization, is seeking two experienced GMP Manufacturing Documentation Specialists 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 Master Batch Records (MBRs) and GMP manufacturing documentation within a sterile injectable or aseptic pharmaceutical environment.
Responsibilities
- 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.
Required Qualifications
- 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 Master Batch Records (MBRs) or Manufacturing Instructions.
- Direct experience supporting sterile injectable, aseptic, biologics, or fill-finish manufacturing .
- 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.
Preferred Experience
- 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
Work Arrangement: 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.
This job opens for applications on 7/17/2026. Applications for this job will be accepted for at least 30 days from the posting date.
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