Full time Life changing therapies. Integral impact. Bridge to thousands of biopharma companies and their patients. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Document

Management and Control – Organize, scan, archive, and maintain R&D; department documentation. Ensure document traceability, version control, template management, and compliance with internal procedures and GMP requirements. Data Management and Reporting – Create, maintain, and update departmental databases and tracking tools using Smartsheet, Excel, and other systems. Compile data generated during trials and batches and prepare process charts, reports, and graphical trend analyses.

Change Control

Support – Coordinate and manage basic document-related change controls and support documentation updates in collaboration with project team members.

Production Data

Collection and Analysis – Obtain and compile primary data from manufacturing equipment in accordance with cGMP requirements and internal PCI procedures. Generate process monitoring charts and supporting documentation.

Training

Administration – Monitor training compliance within the R&D; department and support the creation, maintenance, and filing of training records. Compliance – Maintain knowledge of and comply with all company policies,



internal procedures, quality standards, safety requirements, and applicable cGMP regulations. Knowledge of current Good Manufacturing Practices (cGMP), documentation management principles, data integrity requirements, and pharmaceutical development processes.

Works directly with R&D; management, scientists, technicians, and project teams. Works closely with Quality Assurance, Quality Control, Supply Chain, Operations, Human Resources, Purchasing, and Project Management departments. Coordinates with internal stakeholders regarding documentation, training, materials, procurement activities, and change controls Associate Degree, Vocational Training, or Bachelor's Degree Experience with Microsoft Office applications (Word, Excel, PowerPoint, Teams, Outlook, SharePoint) and database management tools such as Smartsheet.

Familiarity with cGMP documentation practices and document control systems is highly desirable. Creative with the ability to work with minimal supervision and balance with independent thinking. At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled #

📌 Contract System Administrator - On-Site León, Saas It Ops
🏢 Technosylva
📍 León