Job Description

As a QC Information Systems (QCIS) Specialist, you will act as an administrator of computerized systems and business analyst between labs groups and IT for Enterprise projects such as Empower, Biovia Laboratory Execution Systems (LES), Labware, LIMS, and other digital initiatives. Candidates should have a technical understanding of GMP analytical laboratory Information and Enterprise systems. Responsible for day-to-day job functions, administration tasks and can independently represent the team for site and global initiatives.

A typical day will include project work, password resets, user access requests, software troubling shooting, make restricted folders for users, writing SOPs, executing text scripts.

Manager is looking for Software IT experience including software configuration and user management.

Job Responsibilities:

• Perform day-to-day activities and application administration of lab and manufacturing quality control computerized systems.
• Support QC lab functions, providing solutions to a variety of technical problems.
• Participate in software/computer system validation, IT for software/computer applications and fulfill all networking and security requirements, and global IT for enterprise software applications.
• Facilitate and coordinate training of new and existing local admins, prepare training materials as necessary.
• Executes protocols, reports, investigations using, and other records, using Veeva on behalf of QC.
• Support QC information system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement.
• Ability to interpret scientific documentation (quality assay SOPs, Master Specifications, etc.) in order to translate information into static data configuration and reports in LIMS, Empower, and other computerized data management systems, is a plus for some roles within the team.

Education:

• Bachelor’s Degree preferably in Information Systems/Technology or Biotechnology related field.

Spotlight call notes:

• 2+ years information management experience needed to perform well in this role.
• Experience in a scientific lab setting strongly preferred.
• Empower administrator experience required.
• Pharma industry experience preferred.
• Electronic notebook exp
• Previous lab experience but is now in an Admin type of role
• Other possible job title: Systems Administrator
• Could have a biotech degree

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