Pharma Documentation Lead: GMP Compliance & Batch Control

Ttg Talent Solutions; Florida; On-site; USD 55,000 - 60,000; Full time

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

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

Education

High school diploma

Accredited college certificate or university degree preferred

Tools

SAP

QMS systems

Job description

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.