Technical Writer II

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

The OneLIMS EM project technical writer is responsible for supporting on‑time implementation of the OneLIMS EM global system for the Swiftwater, PA site. The role requires performing tasks in an efficient, cGMP‑compliant, and safe manner, adapting quickly to changing priorities in a high‑stress environment, and completing required safety and compliance training and associated modules.

Responsibilities

• Design, develop, and update required technical documentation.
• Assist with editing quality documents (SOPs, guidelines, validation master plans, etc.) 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.

Requirements

• Bachelor’s Degree required.
• Prior experience with quality applications such as Veeva or LIMS.
• Proficiency with MS Word, Excel, PowerPoint, Visio, and Outlook.
• Prior work experience in a good manufacturing practices (GMP) environment.
• Sound interpersonal and information‑gathering skills, ability to work in a team, and effective interaction with others.
• Excellent verbal and written communication skills.
• Minimum two years of related experience.