OneLIMS Technical Writer

Job Title: OneLIMS Technical Writer

Location: Swiftwater, PA

Duration: 6 Months

Shift: M-F 8 AM - 4:30 PM EST

Description: The OneLIMS EM project technical writer is responsible for supporting the on-time implementation of the OneLIMS EM global system for the Swiftwater, PA site. The candidate must perform tasks in an efficient, cGMP-compliant, and safe manner. Success in this position requires the individual to be adaptable and react quickly to changing priorities in a high-stress environment. The candidate is required to complete Safety and Compliance training and associated training modules.

Primary Responsibility: alignment of CPV program with global standards & transfer of Process monitoring trend limits to OneLIMS KEY.

• Design, develop, and update required technical documentation
• Assist with the editing of quality documents (SOPs, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements
• Create training slides and content
• Support Future state process mapping
• Organize, track and plan master data review
• Track and manage project specific deliverables

• Bachelor's Degree required
• Prior experience with quality applications, such as Veeva, LIMS
• Prior experience with MS Word, Excel, PowerPoint, Visio, and Outlook
• Prior work experience in a good manufacturing practices (GMP) environment
• Must possess sound interpersonal and information gathering skills, be able to relate well to others, and have the ability to work in a team environment, effectively interacting with others
• Excellent verbal and written communication skills
• Minimum of 2 years of related experience

• BS in science or engineering
• Preferred: familiarity with OneLIMS, Qualipso, and CPV programs