Production Documentation Officer

Production Documentation Officer
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: Temp to perm

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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