Tellus Solutions is in partnership with a committed biopharmaceutical company in North Chicago focused on providing innovative therapies. Your technical expertise as a
Data Integrity Specialist I in the area of
GxP Data Integrity will contribute to our client's innovative therapies which will impact the quality and duration of life
Responsibilities
Provides compliance support for GxP IT business systems within a 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 supervision of team lead and typically do 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/expectations
- 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
Qualifications
Top skills/requirements/attributes:
- 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 a software validation.
- Understanding IT Lifecycle Management
Years Of Experience, Education, And/or Certification
- Bachelor's Degree or equivalent certification(s) with technical business-oriented