Document Specialist

We are seeking a GMP Manufacturing Documentation Specialist to support multiple technical transfer projects for sterile injectable pharmaceutical products.

Responsibilities

• Author, revise, and coordinate GMP manufacturing documentation.
• Drive approval of Master Batch Records and related controlled documents.
• Collaborate with cross-functional Subject Matter Experts (SMEs) to gather technical information.
• Translate manufacturing processes into compliant documentation.
• Coordinate document reviews and reconcile reviewer comments.
• Facilitate review meetings and drive documentation through the approval process until implementation-ready.
• Support documentation throughout the technical transfer lifecycle, including Engineering, Media Simulation, Clinical, and PPQ manufacturing campaigns.
• Convert validated documentation into commercial Master Batch Records before transferring to Manufacturing Operations.
• Proactively identify gaps and missing manufacturing instructions.

Requirements

• Bachelor's degree in a scientific, engineering, or related technical discipline, or equivalent experience.
• Minimum five years of experience in sterile injectable pharmaceutical manufacturing operations.
• Minimum three years of experience authoring or revising GMP Master Batch Records.
• Knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and ALCOA+ Data Integrity principles.
• Advanced proficiency in Microsoft Word, including complex document formatting and editing.
• Ability to critically review manufacturing documentation and resolve inconsistencies and GMP concerns.
• Strong attention to detail with exceptional proofreading and document quality skills.

Skills

• Technical writing and document control expertise.
• Compliance and data entry skills.
• Quality assurance knowledge.
• Experience with GMP audits.

Work Environment

This position requires working 100% on-site in a GMP environment in Fair Lawn, NJ. The role offers the opportunity to be part of a growing company, gaining valuable experience for future career growth.

Pay

The pay range for this position is $70.00 - $90.00/hr.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)