Technical Writer II

Job Description

Job Summary:

• The OneLIMS EM project technical writer is responsible for supporting on-time implementation of 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.

Duties and Responsibilities:

• Alignment of CPV program with global standards & transfer of Process monitoring trend limits to OneLIMs
• Design, develop, and update required technical documentation.
• Assist with the editing of quality documents (SOP’s, 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 mange project specific deliverables.

Required Qualification:

• Bachelor’s Degree required.
• BS in science or engineering.
• Minimum of 2 + years of related experience.
• 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.

Preferred Qualifications:

• Familiarity with One LIMs, Qualipso, and CPV programs.