|Seeking an experienced LIMS Consultant. This person can work remotely and travel as needed. Previous experience with LIMS (LabVantage a huge plus).|
- Requirements analysis with 3 current sites to understand needs for the upcoming enhancements, including 3 new reports, 2 new labels, and changes in the Sample, Stability, and EM workflows.
- Review of the delivered solution for acceptability, work with the sites to review an provide feedback to development team.
- Analyze and assist with revisions to existing site SOPs and processes to insure adoption of these new enhancements.
- Participate in dry-runs/testing as necessary
- Requirements gathering to complete container management capabilities in the LabVantage LIMS v8 system.
- Deep discussions about current state with the 3 sites
- Review current capabilities of computerized sample location tracking tool
- Review reporting needs, querying capabilities, etc.
- Review approvals, chain of custody, and reporting needs for DEA-acceptable management of controlled substances
- Participate in high-level solution design activities
- Assist in project planning and development of capital request for detailed solution design, validation, and implementation project.
- Strong business systems analysis experience with extensive LIMS experience
- Very strong verbal and written communication skills are essential
- GxP experience in a Pharmaceutical environment / Pharmaceutical experience is a must
- Experience with GxP process methodology
- Experience with complete software development life cycle
- Ability to work expeditiously under an aggressive schedule
- Experience with LIMS / LabVantage is a big plus