Title: Technical Writer II/ QC OneLIMS Data Setup Specialist
Duration: 6 Months+ Possible Extension
Location: Swiftwater, PA (100% Onsite)
Pay Range: $45- $50/hr

Manager Notes:

• Local candidates only, fully onsite

Must have Experience:

• Min Bachelor’s degree and 2+ years of relevant experience
• LIMS, iLMS
• Ability to work Independently
• Strongly Preferred biotech pharma experience

Nice to Have:

• Qualipso
• Experience with methodologies: CPV, Continuous Process Verification have
• Sequel

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.

Primary Responsibility:

• Alignment of CPV program with global standards & transfer of Process monitoring trend limits to OneLIMs

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

Qualification:

• 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. Education: BS in science or engineering

Preferred:

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