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Laboratory Operations Quality Control Information Systems Analyst

2 months ago

Frederick, Maryland, United States Orbis Group Full time

Position: Quality Control Information Systems Analyst

Location: Onsite

Contract Duration: 12 Months

The role involves engaging in project-related tasks, managing user access requests, performing software troubleshooting, and creating secure folders for users. Additionally, the position requires the development of Standard Operating Procedures (SOPs) and executing test scripts.

The hiring manager seeks candidates with a background in Software IT, particularly in software configuration and user management.

As a Quality Control Information Systems (QCIS) Analyst/Senior Analyst, you will serve as the administrator for computerized systems and act as a liaison between laboratory teams and IT for various enterprise projects, including Empower, Biovia Laboratory Execution Systems (LES), Labware, LIMS, and other digital initiatives. A solid technical understanding of Good Manufacturing Practice (GMP) analytical laboratory information and enterprise systems is essential. You will be responsible for daily operations, administrative tasks, and representing the team in site and global initiatives.

Key Responsibilities:

  • Conduct daily activities and manage application administration for laboratory and manufacturing quality control computerized systems.
  • Provide technical support for QC lab functions, offering solutions to diverse technical challenges.
  • Engage in software and computer system validation, ensuring compliance with IT requirements for software applications and global IT for enterprise software.
  • Facilitate training for new and existing local administrators, creating training materials as needed.
  • Execute protocols, reports, and investigations using Veeva on behalf of the QC team.
  • Support the lifecycle management of QC information systems from conception through development, validation, implementation, maintenance, and retirement.
  • Ability to interpret scientific documentation (such as quality assay SOPs and Master Specifications) to translate information into static data configurations and reports in LIMS, Empower, and other computerized data management systems is advantageous for certain roles within the team.

Qualifications:

  • Bachelor's Degree in Information Systems/Technology or a related field in Biotechnology is preferred.
  • 0-3+ years of experience in information management is preferred. Experience in a scientific laboratory setting is a plus.