Jobs

Description

Role: QC OneLIMS Data Setup Specialist

Local candidates only, full onsite No extension at this time Free parking onsite MS, PHD candidates welcomed.

Additional years of experience will be accepted.

Must have Experience:

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

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

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.

Education:

• BS in science or engineering

Preferred:

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