LIMS Technical Consultant
Position: LIMS Consultant
Berg Diagnostics is a Boston based molecular diagnostics company that offers high-throughput omics-based molecular profiling, biomarker validation, and regulated bioanalysis to accelerate development of molecular therapeutics and diagnostics. Armed with the state-of-the-art instrumentation platforms, the company serves to catalyze project end-points in therapeutic and biomarker development
This consultant position is for the Clinical Diagnostics division, CLIA certified Laboratory at Berg Diagnostics, 500 Old Connecticut Path, Building B, Framingham, MA.
The responsibilities are:
- Responsible for supporting all aspects of validation of the Laboratory Information Management System
- Position will help design and execute LIMS validation scripts.
- Lead and coordinate technical issue investigations and manage technology resolution implementations.
- Manage Change Control, versioning, and documentation of system to meet both CLIA and FDA guidelines.
- Provide regulatory input to create a validated LIMS system to meet CLIA and FDA guidelines.
- Interact with IT team to ensure LIMS integration into existing IT structure.
- Bachelor's degree in Information Technology, Computer Science or an equivalent degree in Science with strong computer skills.
- Experience supporting commercial LIMS systems and validation of software.
- Knowledge of Clinical and Clinical Research Laboratory activities.
- Ability to work with minimum supervision.
- Ability to work with in project team setting with multiple department interactions.
- Knowledge of Oracle and SQL Server databases, CFR 21 Part 11 regulations, and SQL query scripting preferred.
Kindly apply with a resume to firstname.lastname@example.org with Job Code : CLIA – LIMS