Production Lead – Pharmaceutical Manufacturing

ttg Talent Solutions; Fort Lauderdale (FL); On-site; USD 95,000 - 135,000; Full time

Job summary

ttg Talent Solutions is seeking an experienced Production Documentation Lead for pharmaceutical manufacturing on-site in Florida. The role centers on creating, developing, and maintaining technical manufacturing documentation to meet FDA and cGMP standards.

The ideal candidate has hands-on experience writing GMP documentation from scratch, with focus on SOPs, MBRS, and manufacturing instructions, and works cross-functionally with QA, QC, Engineering, and Maintenance.

Qualifications

• Minimum 5+ years in pharma manufacturing documentation in a cGMP environment.
• Direct hands-on experience creating GMP documentation from scratch.
• Strong ability to develop SOPs, Batch Records, and manufacturing procedures.
• Experience contributing to deviations, change controls, and URS.
• Knowledge of FDA, cGMP, GDP and quality systems.

Responsibilities

• Create, revise, and maintain SOPs, MBRS, Batch Records and manufacturing instructions.
• Prepare URS, protocols, equipment qualification documents, and process documentation.
• Draft deviations, change controls, and other QMS documents.
• Maintain production-related records: logs, in-process docs, cleaning, equipment calibration, maintenance.
• Collaborate with Production, QA, QC, Engineering, and Maintenance to capture accurate technical information.
• Translate procedures and equipment needs into clear, compliant controlled documents.
• Support documentation for new equipment, process changes, and qualification activities.
• Ensure adherence to cGMP, GDP, FDA regulations and internal SOPs.

Skills

Technical writing

GMP documentation

SOP development

Cross-functional collaboration

Tools

SAP

MES

QMS software

Job description

Production Documentation Lead – Pharmaceutical Manufacturing

Work Arrangement: On-site

Schedule: Full-Time | Monday–Friday

Pay Rate: Based on Experience

Position Overview

ttg Talent Solutions is seeking an experienced Production Documentation Lead to support pharmaceutical manufacturing operations in a cGMP-regulated environment.

This position focuses on the creation, development, and maintenance of technical manufacturing documentation, ensuring that production processes, equipment-related activities, and quality requirements are accurately documented in compliance with FDA and cGMP standards.

The ideal candidate has a strong background in pharmaceutical manufacturing and direct experience writing and creating GMP documentation from scratch, rather than solely reviewing or approving existing documents.

Key Responsibilities

• Create, develop, and revise Standard Operating Procedures (SOPs), Master Batch Records (MBRs), Batch Records, and manufacturing instructions.
• Prepare technical documentation, including User Requirement Specifications (URS), protocols, equipment qualification documents, and manufacturing process documentation.
• Draft and support deviations, Change Controls, and other Quality Management System (QMS) documentation.
• Develop and maintain production-related records, including logbooks, in-process documentation, cleaning and sanitation records, equipment verification/calibration records, and maintenance documentation.
• Collaborate with Production, QA, QC, Engineering, and Maintenance to gather technical information and ensure documentation accurately reflects manufacturing processes.
• Translate manufacturing procedures, equipment requirements, and operational activities into clear, accurate, and compliant controlled documents.
• Support documentation associated with new equipment, process changes, qualification activities, and manufacturing improvements.
• Ensure documentation complies with cGMP, GDP, FDA regulations, and internal SOPs.
• Maintain document accuracy, traceability, version control, and timely completion of documentation activities.

Qualifications

• 5+ years of recent experience in the pharmaceutical industry, preferably supporting manufacturing operations in a cGMP-regulated environment.
• Required: Direct hands-on experience creating and writing pharmaceutical manufacturing documentation, not limited to document review or approval.
• Strong experience developing SOPs, Batch Records, manufacturing procedures, and controlled GMP documents.
• Experience preparing or contributing to deviations, Change Controls, qualification protocols, URS, or equipment-related documentation.
• Solid understanding of pharmaceutical manufacturing processes, production equipment, and operational workflows.
• Familiarity with QMS, SAP, MES, or similar pharmaceutical manufacturing/documentation systems.
• Knowledge of FDA regulations, cGMP, GDP, and pharmaceutical Quality requirements.
• Experience with inhalation or respiratory pharmaceutical manufacturing, including MDI/DPI processes, is highly preferred.
• Strong technical writing, attention to detail, problem-solving, and cross-functional communication skills.

ttg Talent Solutions is an Equal Opportunity Employer and recruiting agency. We are committed to creating an inclusive and diverse work environment and welcome applications from all qualified candidates regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, or veteran status. Please note that all offers of employment are contingent upon the successful completion of a drug test and background check. We maintain a drug- and substance-free workplace to ensure the safety and well-being of all employees.

At ttg, "We believe in making a difference One Person at a Time," ttg OPT.