GMP Technical Documentation Specialist (LIMS/SOPs)

Katalyst CRO; Swiftwater (Monroe County); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO is seeking a technical writer to support the OneLIMS EM project at the Swiftwater, PA site. You will design, develop, and maintain required documentation in a cGMP-compliant environment, and create training materials for a fast-paced setting.

The role requires collaboration across teams, strong written/verbal communication, and ability to adapt to changing priorities while completing required safety and compliance training.

Qualifications

• Bachelor’s degree required.
• Minimum two years of related experience.
• Experience in GMP environment advantageous.
• Proficiency in MS Office applications (Word/Excel/PowerPoint/Visio/Outlook).

Responsibilities

• Design, develop, and update technical documentation.
• Assist with editing quality documents to ensure regulatory compliance.
• Create training slides and content.
• Support future-state process mapping.
• Organize, track, and plan master data review.
• Track and manage project-specific deliverables.

Skills

Interpersonal skills

Verbal communication

Written communication

Teamwork

Education

Bachelor's degree

Tools

MS Word

MS Excel

MS PowerPoint

MS Visio

MS Outlook

Job description

Katalyst CRO is seeking a technical writer to support the OneLIMS EM project at the Swiftwater, PA site. You will design, develop, and maintain required documentation in a cGMP-compliant environment, and create training materials for a fast-paced setting.

The role requires collaboration across teams, strong written/verbal communication, and ability to adapt to changing priorities while completing required safety and compliance training.