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Technical Writer II

Job in Swiftwater, Monroe County, Pennsylvania, 18370, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-07-13
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 70000 - 90000 USD Yearly USD 70000.00 90000.00 YEAR
Job Description & How to Apply Below

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.
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