Production Documentalist

Jubilant Radiopharma; Kirkland; On-site; CAD 48,000 - 72,000; Full time

Job summary

Jubilant Radiopharma in Montreal, Canada, is seeking a Production Documentalist to ensure accuracy and compliance of manufacturing documentation. This role collaborates with Production, Quality Control, and Quality teams to maintain GMP-aligned records and drive continuous improvement.

Responsibilities include coordinating documentation for batches, verifying documents, archiving records, and generating weekly KPI reports to support Operations and Quality Control.

Qualifications

• Experience in pharmaceutical production and documentation workflows.
• Knowledge of Good Manufacturing Practices (GMP) is advantageous.
• Strong written and verbal communication skills in English and French may be required.
• Proficiency with MS Word, Excel and SAP for documentation tasks.

Responsibilities

• Coordinate and distribute manufacturing documentation for batches following production activities.
• Verify and release GMP documentation with Quality teams; ensure alignment with control systems.
• Print and prepare documentation for production operations and archiving.
• Prepare weekly KPI reports related to documentation performance.
• Collaborate with Production and Quality to improve right-first-time documentation.

Skills

Detail orientation

Attention to detail

Communication

Teamwork

GMP awareness

Tools

Microsoft Word

Excel

SAP

Job description

At Jubilant Radiopharma, we help support patient care through the manufacturing and distribution of high-quality radiopharmaceutical products. Our success is built on talented people, collaboration, and a commitment to excellence.

We are looking for a detail-oriented and organized Production Documentalist to join our team. In this role, you will help ensure the accuracy, completeness, and compliance of critical production documentation.

Role Overview

The Production Documentalist is responsible for coordinating, reviewing, and managing manufacturing documentation. Working closely with Production, Quality Control, and Quality teams, this role helps maintain documentation integrity, supports compliance with good documentation practices, and contributes to continuous improvement initiatives.

Key Responsibilities

• Coordinate and distribute documentation related to manufacturing batches following production activities.
• Monitor orders within company systems to support timely delivery and a just-in-time production environment.
• Print and prepare documentation required for production operations.
• Verify printed documents and ensure their release by the Quality team.
• Ensure adherence to good documentation practices.
• Review and approve batch records and GMP documentation, including logbooks, AWOs, registers, and other GMP-related documents.
• Contribute to continuous improvement of documentation and batch record review processes.
• Prepare weekly KPI reports related to documentation performance within Operations and Quality Control.
• Partner with Quality to support document management and archiving activities.
• Collaborate with the Production Supervisor to improve documentation accuracy and right-first-time performance.
• Perform other related duties as required to support operations.

Qualifications

• Experience in pharmaceutical production.
• Manual dexterity, strong attention to detail, and ability to maintain concentration.
• Strong communication and teamwork skills.
• Knowledge of Good Manufacturing Practices (GMP) is an asset.
• Proficiency with Microsoft Word, SAP, and Excel.
• Knowledge of spoken and written French and English to use systems that are available only in English.