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Technical Writer II

Katalyst CRO

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. #J-18808-Ljbffr

Vacancy posted 2 days ago
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