GMP Manufacturing Documentation Specialist

Actalent • Fair Lawn, NJ • 1d ago

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.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

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

Application Deadline

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 actalentaccommodation@actalentservices.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.

Similar Jobs

Director, Strategy/M&A Execution Supply Chain

KPMG LLP • New York, NY • 17h ago

Manufacturing & Warehouse

The KPMG Advisory practice is at the forefront of transformation, offering excellent opportunities for individuals to advance their careers and expertise with KPMG. Looking ahead, we anticipate continued evolution and su...

17h ago

Go to Apply

Houston/New York/Toronto/Washington, D.C. Energy & Infrastructure Projects Mid

Skadden, Arps, Slate, Meagher, & Flom LLP • New York, NY • 18h ago

Manufacturing & Warehouse

The Energy & Infrastructure Projects group is seeking mid to senior level associates/counsel with at least 3 plus years of law firm experience (class of 2023 and above) to join the team in either Houston, New York, W...

18h ago

Go to Apply

Manufacturing Operator (Dehydration) 1st Shift - Clark, NJ

Kerry • Clark, NJ • 1d ago

Manufacturing & Warehouse

?Requisition ID 65820 Position Type (US)Full Time Workplace Arrangement #LI-Onsite About Kerry Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we p...

1d ago

Go to Apply

Supply Chain Planner

Robert Half • Saddle Brook, NJ • 1d ago

Manufacturing & Warehouse

Description We are looking for a Supply Chain Planner to support manufacturing operations in Fair Lawn, New Jersey. This Long-term Contract position will oversee production planning activities, help maintain reliable del...

1d ago

Go to Apply

WAREHOUSE ATTENDANT (FULL TIME)

Compass Group, North America • Parsippany, NJ • 1d ago

Manufacturing & Warehouse

Canteen We are hiring immediately for full time WAREHOUSE ATTENDANT positions. Location : Corporate Essentials - 2 Cranberry Road Unit #2, Parsippany, NJ 07054. Note: online applications accepted only . Schedule : Full t...

1d ago

Go to Apply

Warehouse Staff

City of New York • New York, NY • 2d ago

Manufacturing & Warehouse

Job Description The Department of Records is seeking to hire one warehouse staff person to work at the Municipal Records Center, located in Middle Village, Queens. The candidate for this position will be expected, under...

2d ago

Go to Apply

Warehouse Janitorial Cleaner

ABM Industries • Little Falls, NJ • 2d ago

Manufacturing & Warehouse

Overview Position Summary Details The Cleaner position provides the cleaning and upkeep of an assigned area. Payrate $18.00 per hour. The pay listed is the hourly range or the hourly rate for this position. A specific of...

2d ago

Go to Apply

Warehouse Janitorial Cleaner

ABM Industries • Kearny, NJ • 2d ago

Manufacturing & Warehouse

2d ago

Go to Apply

Strategic Insights Lead, Industry Transformation

Google • New York, NY • 2d ago

Manufacturing & Warehouse

Strategic Insights Lead, Industry Transformation corporatefare_ Google place New York, NY, USA Advanced Experience owning outcomes and decision making, solving ambiguous problems and influencing stakeholders; deep expert...

2d ago

Go to Apply

Manufacturing Trainer

OWENS CORNING CORPORATE SERVICES, LLC • Kearny, NJ • 3d ago

Manufacturing & Warehouse

Experience Required None Minimum Education Required High School Diploma or Equivalent Compensation $15.92 / Hourly Hours Per Week 40 Number Of Positions 1 Shift First Shift (Day) Job Description Manufacturing Trainer Loc...

3d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)