Quality Specialist II
Gravity IT Resources
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Job Description:
The Quality Specialist II – MODA Environmental Monitoring System Administrator will bring their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The MODA System Administrator is responsible for the implementation, management, and ongoing maintenance of our clients’ MODA system
Essential Duties and Responsibilities:
- Manages MODA Environmental Monitoring (EM) System.
- Creates and Maintains User Accounts.
- Builds and manages static data.
- Supports/manages and entry of data.
- Develops and implements ongoing training.
- Ensures controls related to approval levels and user access are established and maintained.
- Manages user inquiries for troubleshooting and resolves issues.
- Proactively identifies and works to resolve project and system issues.
- Ensures MODA conforms to regulatory requirements.
- Oversees and participates in the development of application documentation.
- Works in coordination with business stakeholders to develop and prepare reports, metrics, and dashboards.
- Works closely with various business stakeholders to lead and manage business requirements and system solution delivery.
- Manages ongoing maintenance and enhancements (i.e. new releases)
- Drive improvements and efficiencies.
- Supports adding vault capabilities as identified by the business.
Basic Qualifications and Capabilities:
- Bachelor’s Degree in a related field plus 6+ years of Quality Control MODA Environmental Monitoring Administrator experience, or equivalent work experience is required.
- Proven experience in leading and deploying an environmental monitoring system.
- Experience in a pharmaceutical or any highly regulated environment.
- Knowledge of Quality Assurance/Quality Control Operations.
- Experience with system design and development starting from business requirements analysis through implementation and support.
- Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
- Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
Preferred Qualifications:
- Strong knowledge of computerized system validation
- Experience with ELN and implementation of paperless lab.
- A strong knowledge of the computerized system principles, standards, and regulations, such as GAMP 5, 21 CFR Part 11, EU Annex 11, etc.