What are the responsibilities and job description for the LIMS System Admin position at Insight Global?
JOB DESCRIPTION
Supports the Quality Assurance department by performing Quality Operations Systems activities related to LIMS associated with clinical and commercial products, raw materials, validation, stability, and environmental monitoring.
Demonstrates the following:
Demonstrates the following:
- Knowledgeable of the principles and concepts of current Good Manufacturing Practices (cGMPs) to be a key contributor
- Capability of understanding requirements of LIMS builds
- Capability of designing queries to retrieve LIMS master data
- Identifies issues and reports them to appropriate management attention immediately Able to resolve issues and represents QO in cross-departmental meetings
- Ability to identify issues, present complex problems with possible solutions, and actively takes leadership role to resolve those issues
- Good judgment and decision making based on procedures, PQSs, technical experience; and industry guidance/regulatory regulations
- Collaborates and engages with a wide range of co-workers, customers, and management to gather the input and background knowledge needed to complete assignments
- Identifies and takes action/seeks advice when a personal or project goal/deliverable is off schedule
- Ability to organize own work to meet project deadlines
- Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development
- Effective written and verbal communication and interpersonal skills
- Can generate metrics to support continuous improvement of the site
- Plan and execute projects
- Suggest improvements and participates in continuous improvement activities
- Responsible for prioritization and associated timely completion of activities/deliverables
- Support regulatory audits as needed
MINIMUM REQUIREMENTS
- At least 3-5 years of industry experience
- Knowledgeable of the principles and concepts of current Good Manufacturing Practices (cGMPs) of US, EU, and ROW.
- Good judgment and correct decision making based on company procedures, PQSs, technical experience; and industry guidance / regulatory regulations
- Experience with and knowledge of aseptic manufacturing procedures
- Knowledge of Lean Six Sigma concepts.
DESIRED SKILLS
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