GxP Data Integrity Specialist
12-month initial contract with extensions
Hybrid Schedule:
(T, W, TR in office, possibly remote on M&F)
Lake County, IL
$26/HR
Orion Group is hiring for a GxP Data Integrity Specialist to join our multinational pharmaceutical client in Lake County.
The GxP Data Integrity Specialist will be an individual contributor within an R&D Scientific Compliance group that supports various topics and processes.
This position is a modern hybrid work environment; comfortable, collaborative onsite work setting with professional equipment. At times, work will be performed in an R&D scientific laboratory.
The GxP Data Integrity Specialist will directly report to their supervisor for day-to-day guidance and assignment of work activities, with increasing individual work time based on proven competency.
Individuals with agile business communication skills, more advanced computer software systems, and administration/support skills are more likely to succeed in this position.
GxP Data Integrity Specialist Responsibilities:
- Provides compliance support for GxP IT business systems within an R&D bio-pharmaceutical scientific organization
- Reviews, analyzes and evaluates systems and user needs
- Documents requirements, supports scope, and objectives in support of business strategies
- Manage laboratory instrument systems
- Work is managed via the supervision of the team lead and typically does not require exercising independent judgment
- Provide day-to-day support for laboratory scientific staff, including troubleshooting, system enhancements, training, etc.
- Work in a highly team-based, cross-functional environment for daily activities, decision-making, and project focus while exhibiting a “one-compliance” voice approach
- Identify and recommend practical solutions for improved business process efficiency
- Ability to manage several tasks simultaneously while ensuring all timelines are met
- Anticipate and respond to urgent and/or unexpected events and changing business needs with minimal impact on productivity
- Support Compliance/Business/QA partnership needs and initiatives for continuous improvement to enhance efficiency and compliance
- Provide input to regulatory and compliance requirements/expectation
Identify and appropriately escalate potential compliance risks and/or issues as they arise
- Use sound and balanced judgment to discern the criticality of issues and act upon them accordingly
GxP Data Integrity Qualifications:
- In-depth GxP Data Integrity understanding in a biopharma industry (at least 1 year experience)
- Efficient work planning, self-checking, execution, and accountability without requiring excessive direction and raises key questions when necessary.
- Proactive, transparent communication and collaboration with team leadership and other team members in a fast-paced, team-oriented environment
- IT Project Management experience, including software validation.
- Understanding IT Lifecycle Management.
- Bachelor’s Degree or equivalent certification(s) with technical business-oriented
- Laboratories Systems/software support, Direct experience with SNOW and or KNEAT as well as platforms, e.g.,), Microsoft365 and/or SharePoint applications
- PM Certification, ITIL Certification, familiarity with general scientific terminology, e.g., chemist, biologist, instrument, analytical testing, study, clinical, active ingredient, drug product
