Documentation Specialist

Documentation Specialist

Apply for the Documentation Specialist role at Katalyst CRO
.

• Review and verify manufacturing Batch Production Records (BPRs) to ensure compliance with internal specifications, cGMP regulations, and ISO 13485 guidelines.
• Review production schedules with various departments to ensure alignment and efficiency.
• Manage the lifecycle of production documents, including creation, review, approval, and archiving.
• Manage the printing, distribution, and tracking of all production-related documentation.
• Ensure accuracy, traceability, and compliance of Batch Production Records (BPRs), Bills of Materials (BOMs), Protocols, and Labels for production.
• Utilize systems such as SAP and other relevant software for documentation and data management.
• Collaborate cross‑functionally on documentation improvement projects to maintain integrity and compliance.
• Liaise with teams including Quality, Regulatory Affairs, and Supply Chain to ensure seamless information flow.

• High school diploma or equivalent experience required.
• 3-5 years in a GMP manufacturing environment.
• Experience in the pharmaceutical or medical device industry.
• Strong knowledge of cGMP regulations and ISO 13485 standards.
• Proficiency in Microsoft Office suite.
• Excellent organizational and communication skills.

Mid‑Senior level

Full‑time