GMP Manufacturing Documentation Specialist

Job Description

Job Description

Job Title: GMP Manufacturing Documentation Specialist

Job Description

We are seeking a GMP Manufacturing Documentation Specialist to support multiple technical transfer projects for sterile injectable pharmaceutical products. This role entails authoring, revising, coordinating, and driving approval of GMP manufacturing documentation, with a primary focus on Master Batch Records (MBRs) and related controlled manufacturing documents.

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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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. The role offers the opportunity to be part of a growing company, gaining valuable experience for future career growth.

This is a Contract position based out of Fair Lawn, NJ.

The pay range for this position is $40.00 - $45.00/hr.

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 the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 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)

This is a fully onsite position in Fair Lawn,NJ.

This position is anticipated to close on Aug 6, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.