Global Specimen Solutions (GSS) is wholly owned company of Covance Inc., providing specialty services in the holistic specimen tracking space. GSS improves translational science through industry best practices and a uniquely powerful pipeline data management analytics solution. GSS reduces the time, cost and risk of specimen based research, while building robust, healthy data pipelines that optimize research opportunities.
- Performs monitoring of production data feeds including, but not limited to, examining the following.
- File delivery schedule met.
- Data feed executed to completion correctly.
- Number of record errors, by category, is within acceptable tolerance by error type.
- Number of record errors not categorized.
- Triages unacceptable errors for resolution.
- If error matches known error type, with known standard resolution, implement known resolution.
- Manually re-execute data load for data feeds that have had standard resolutions applied.
- For unknown errors, investigate to point of understanding resolution, or as far as possible.
- Escalate findings to Data Monitor Lead.
- Develop new standard monitoring scripts for unknown errors and develop standard resolutions instructions.
- Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle.
- There are no customer facing job functions in this position.
- Support management of metrics.
- Assist with investigating or resolving issues of quality as directed.
- Staff and Financial Management
- Understand implications of activities to project budgets.
- Suggest process improvements where issues are seen.
- Support Six Sigma process improvement teams.
Training / SOPs
- Reviews training materials for staff.
- Mentor and support other GSS employees in their understanding and adoption of data feed configuration and date point mapping development.
- Active member of SOP review teams as assigned.
- Lead or assist with special projects as designated.
- Perform other duties as assigned by management.
University/College Degree degree preferably in the sciences or related field, with one-two years in a data analysis and/or profiling position.
- Minimum 6 months to 2 years data informatics experience or equivalent work experience in a regulated (FDA, EPA, etc.) environment.
- Strong attention to detail.
- Strong analytical skills, preferably in a GCP environment.
- Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
- Problem Solving/Logic Skills.
- Strong communication and interpersonal skills.
- Working knowledge of SQL
- Strong MS/Office skills in particular with Excel and Word.
- Understanding of database query tools, such as DB Forge or Navicat, preferred.
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