Onsite GMP Doc Specialist - Master Batch Records

Piper Companies; Ridgefield (NJ); On-site; USD 157,597,440 - 186,251,520; Full time

Job summary

Piper Companies is seeking two GMP Manufacturing Documentation Consultants to join a 12-month, on-site engagement in Ridgefield, NJ. The role centers on authoring and maintaining Master Batch Records (MBRs) and other GMP documentation for a sterile injectable program.

Ideal candidates have hands-on MBR experience in aseptic/pharmaceutical environments, solid knowledge of cGMP/GDP/ALCOA+ data integrity, and advanced MS Word skills. Onsite work Monday through Friday with DOE pay rates.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• Minimum 5 years of experience supporting GMP pharmaceutical manufacturing.
• Minimum 3 years authoring or revising Master Batch Records (MBRs) or Manufacturing Instructions.
• Direct experience supporting sterile injectable, aseptic, biologics, or fill-finish manufacturing.

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, 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.

Skills

GMP documentation

Technical writing

Attention to detail

Cross-functional collaboration

Microsoft Word (advanced)

Education

Bachelor's degree in Engineering, Life Sciences, or related

Tools

Microsoft Word

Job description

Piper Companies is seeking two GMP Manufacturing Documentation Consultants to join a 12-month, on-site engagement in Ridgefield, NJ. The role centers on authoring and maintaining Master Batch Records (MBRs) and other GMP documentation for a sterile injectable program.

Ideal candidates have hands-on MBR experience in aseptic/pharmaceutical environments, solid knowledge of cGMP/GDP/ALCOA+ data integrity, and advanced MS Word skills. Onsite work Monday through Friday with DOE pay rates.