Jobs

Description

Role will work with a team on a new digital system to convert information into training materials.

No evenings or weekends required

No travel involved

Schedule: Monday–Friday, 8:00 AM – 4:30 PM (slight flexibility)

Fully onsite position

Required Experience/Skills:

• Minimum bachelor’s degree required; master’s and PhD candidates are welcome
• Preferred areas of study: IT or sciences Minimum of 2+ years of experience in a similar role; more years of experience is acceptable.

Nice-to-Have / Preferred Skills:

• Background in digital IT or scientific fields Experience with QC (quality control) activities
• Experience with LIMS systems (e.g., LabVantage, iLMS, Sequel, or related systems)
• Experience deploying digital systems (e.g., LabWare, LIMS) strongly preferred Knowledge of validation processes is a plus
• Previous experience in pharmaceutical, analytical, or biotech environments (e.g., Veeva) preferred
• Proficiency in PowerPoint with the ability to create training materials, including slides and graphics Strong presentation skills

Description

• 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.

KEY RESPONSIBILITIES:

• 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

QUALIFICATIONS:

• 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.