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.
Issue Resolution Team Associate (IRT Associate) for Global Specimen Solutions is responsible and accountable to deliver tasks according to procedural requirements and agreed upon service levels of Global Specimen Solutions for Covance Central Laboratory Services.
Review of the data management issues, identify the resolution and report.
Analyze the source systems for issues related to the data.
Develop a simple way to raise, resolve, record and manage the issue/s until close out.
Document the steps followed to resolve the issues and create knowledge base document.
Analyze and resolve an issue to restore the project specific process.
Support team to identify and raise issues, follow-up and close out.
Monitor the process, recommend improvements, ensuring the process is followed.
Remediate errors and omissions from review.
Escalate unresolved issues to the next level.
Communicate all the required information on issue resolution to the team.
Acknowledge the completion of the ticket.
Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the System Development Life Cycle
University/College Degree preferably in the life science background or engineering field.
In addition to above, candidates without life sciences background but with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities
Minimum 2-4 years of data informatics experience or equivalent work experience in a regulated (FDA, EPA, etc.) environment.
Good knowledge in Database Management concepts, database designs and database administration.
Experience in SQL programming and RDMS structure and relationships
Writing SQL queries to pull data for analysis/resolution purpose
Strong analytical skills and attention to detail.
Ability to work in a rapidly changing environment
Independently analyze, solve, and correct issues in real time, providing problem resolution end-to-end.
Experience with 21 CFR Part 11 in a pharmaceutical, biotechnology, CRO or related industry.
Self-motivated, able to work with minimal oversight
Strong communication and interpersonal skills.
Strong MS/Office skills in particular with Excel and Word.
Understanding of database query tools, such as DB Forge or Navicat, is an advantage