Information Technology Support Specialist

1 week ago

North Chicago, United States Collabera Full time

We are seeking a Compliance Specialist to provide compliance support for GxP IT business systems within a research and development (R&D) bio-pharmaceutical scientific organization. The ideal candidate will have experience in managing laboratory instrument systems, understanding GxP data integrity, and working in a highly team-based, cross-functional environment. This role will require effective communication, collaboration, and the ability to anticipate and respond to urgent business needs.


Key Responsibilities:

Compliance Support for GxP IT Systems:

  • Review, analyze, and evaluate business systems and user needs.
  • Document requirements and support scope and objectives in alignment with business strategies.
  • Manage and support laboratory instrument systems.
  • Provide day-to-day support for laboratory scientific staff, including troubleshooting, system enhancements, and training.
  • Operate under the guidance of a team lead with minimal need for independent judgment.


Cross-Functional Collaboration:

  • Work in a team-based, cross-functional environment to support daily activities, decision-making, and project-focused initiatives.
  • Identify and recommend practical solutions to improve business process efficiency.
  • Manage multiple tasks simultaneously while ensuring timelines are met.
  • Anticipate and respond to urgent or unexpected events and evolving business needs with minimal impact on productivity.


Support Compliance and Continuous Improvement Initiatives:

  • Provide input on regulatory and compliance requirements and expectations.
  • Identify and escalate potential compliance risks or issues as they arise.
  • Use sound judgment to discern the criticality of issues and act upon them accordingly.


Qualifications:

Required Skills and Experience:

  • At least 1 year of in-depth GxP Data Integrity experience in the biopharma industry.
  • Strong skills in work planning, self-checking, execution, and accountability without needing excessive direction.
  • Proactive and transparent communication and collaboration with team leadership and members in a fast-paced, team-oriented environment.
  • IT Project Management experience, including software validation.
  • Understanding of IT Lifecycle Management.


Education and Certifications:

  • Bachelor’s Degree or equivalent certification(s) in a technical or business-oriented field.


Preferred Skills and Experience:

  • Experience in laboratory systems or software support.
  • Familiarity with ServiceNow (SNOW), KNEAT, Microsoft 365, and SharePoint applications.
  • PM Certification or ITIL Certification.
  • Familiarity with general scientific terminology (e.g., chemist, biologist, instrument, analytical testing, study, clinical, active ingredient, drug product).


Work Environment:

  • The candidate will be an individual contributor within an R&D Scientific Compliance group supporting a variety of topics and processes.
  • A hybrid work environment offering a collaborative and comfortable onsite work setting with professional equipment.
  • Occasional work in an R&D scientific laboratory environment may be required.

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