Production Documentation Lead - Pharmaceutical Manufacturing

Ttg Talent Solutions; Florida; Presencial; USD 55.000 - 60.000; Jornada completa

Descripción de la vacante

ttg Talent Solutions seeks a Production Documentation Lead for pharmaceutical manufacturing in Coral Springs, FL. On-site, full-time role with occasional overtime. You will ensure GMP-compliant documentation across batch records, SOPs, URS, and qualification docs, using SAP and QMS systems.

Requires 5+ years in a cGMP environment, strong document control, and knowledge of FDA/cGMP. High school diploma; college degree preferred.

Formación

• High school diploma.
• Accredited college certificate or university degree preferred.
• Minimum of five years of experience or training in a cGMP production environment.

Responsabilidades

• Handle and maintain documentation used on the pharmaceutical production floor.
• Prepare and update Standard Operating Procedures.
• Prepare User Requirement Specifications for production equipment.
• Prepare protocols and qualification documents.
• Support the preparation and processing of change controls.
• Document and support deviations.
• Complete and review Batch Records.
• Maintain production and in‑process documentation.
• Complete equipment and production logbooks.
• Maintain weighing‑balance verification and calibration records.
• Maintain cleaning and sanitation records.
• Maintain maintenance records.
• Support documentation related to equipment qualification.
• Ensure documents comply with cGMP, GDP, SOP, and regulatory requirements.
• Support Quality Management System documentation, including OOS and OOT records.
• Support employee training documentation and training processes.
• Use SAP and QMS systems as required.
• Maintain documentation accuracy, traceability, and completeness.
• Support manufacturing teams with documentation‑related questions.
• Maintain familiarity with manufacturing, filling, and packaging workflows for MDI and DPI products.
• Follow all health, safety, and PPE requirements applicable to the production environment.

Conocimientos

GMP documentation

SOP preparation

Batch Record completion

User Requirement Specifications

Protocol and qualification

Change control

Deviation documentation

OOS and OOT documentation

Quality Management Systems

Document control

Good Documentation Practices

Training documentation

Attention to detail

Cross‑functional communication

Educación

High school diploma

Accredited college certificate or university degree preferred

Herramientas

SAP

QMS systems

Descripción del empleo

08th Octob​er, 2026

Production Documentation Lead - Pharmaceutical Manufacturing

Location: Coral Springs, Florida

Type of Work: On-site

Schedule: Full-time; M - F. Overtime and weekend work may occasionally be required.

Type of Contract: $55K - 60K

Description

The Production Documentation Officer is responsible for preparing, maintaining, reviewing, and completing documentation used in pharmaceutical manufacturing operations. The position supports the production floor by ensuring that Batch Records, SOPs, equipment documentation, qualification records, change controls, deviations, and other GMP documents are accurate, complete, and compliant.

This role requires strong knowledge of pharmaceutical shop‑floor documentation, Quality Management System processes, and regulated production environments.

Responsibilities and Duties

• Handle and maintain documentation used on the pharmaceutical production floor.
• Prepare and update Standard Operating Procedures.
• Prepare User Requirement Specifications for production equipment.
• Prepare protocols and qualification documents.
• Support the preparation and processing of change controls.
• Document and support deviations.
• Complete and review Batch Records.
• Maintain production and in‑process documentation.
• Complete equipment and production logbooks.
• Maintain weighing‑balance verification and calibration records.
• Maintain cleaning and sanitation records.
• Maintain maintenance records.
• Support documentation related to equipment qualification.
• Ensure documents comply with cGMP, GDP, SOP, and regulatory requirements.
• Support Quality Management System documentation, including OOS and OOT records.
• Support employee training documentation and training processes.
• Use SAP and QMS systems as required.
• Maintain documentation accuracy, traceability, and completeness.
• Support manufacturing teams with documentation‑related questions.
• Maintain familiarity with manufacturing, filling, and packaging workflows for MDI and DPI products.
• Follow all health, safety, and PPE requirements applicable to the production environment.

Requirements

• High school diploma.
• Accredited college certificate or university degree preferred.
• Minimum of five years of experience or training in a cGMP production environment, or an equivalent combination of education and experience.
• Strong knowledge of pharmaceutical manufacturing documentation.
• Experience preparing SOPs, Batch Records, URS documents, protocols, and qualification records.
• Knowledge of Quality Management System documentation, including change controls, deviations, OOS, and OOT.
• Familiarity with training processes.
• Familiarity with SAP and QMS systems.
• Basic understanding of GMP equipment operation and production process flow.
• Basic knowledge of MDI and DPI manufacturing, filling, and packaging operations.
• Knowledge of FDA requirements, cGMP, GDP, SOPs, and controlled documentation.
• Ability to read, write, and communicate effectively in English.
• Ability to complete regulated documentation accurately.
• Ability to follow detailed written instructions.
• Ability to work within the physical and environmental conditions of a pharmaceutical production facility.

Skills

• GMP documentation
• SOP preparation
• Batch Record completion
• User Requirement Specifications
• Protocol and qualification documentation
• Change control
• Deviation documentation
• OOS and OOT documentation
• SAP
• Quality Management Systems
• Document control
• Good Documentation Practices
• Training documentation
• Attention to detail
• Cross‑functional communication

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

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