Serves as a GxP Systems subject matter expert and provides guidance to the functional team and end users.
This role will translate business needs into maintainable configurations, extensions and customization's of the Mirth Connect and associated Enterprise Application systems, which may include LIMS, in a GXP compliant manner.
Responsibilities include the Design/Configuration of GxP System applications to support enhancement efforts and provide production support through the functional team.
Lead the development of applications, such as Mirth Connect, for data management and integration with Sponsors data needs
Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
Configure LIMS to meet end-user needs and those of the clinical trial partners.
Work in conjunction with end-users to identify and determine operational objectives/system functionality.
Gather specifications, design workflow charts and diagrams, study system capabilities, identify and develop solutions to meet business and compliance needs.
Maintain system and operational policies and procedures in alignment with Quality best practices.
Perform program configuration/modification and set-up activities on projects according to established procedures.
Maintain laboratory GxP systems with all requirements and manage Standard Change Requests.
Coordinate with functional team for all activities related to GxP Systems configuration, implementation, control, and customer support.
Write technical and validation documents such as URS, IQs, OQs, and SOPs
Ensuring that Quality Events such as incidents and deviations are properly documented, and for supporting/owning the immediate remediation and preventative actions
Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed
Bachelor’s Degree in a related scientific field or computer science/IT/MIS with a minimum of 5 years relevant experience required
Preferred minimum of 2 years of experience in a clinical trial or pharmaceutical setting.
Experience in Mirth Connect v3.2.2 or higher
Experience in supporting computer systems and maintaining compliance in a regulated environment.
Computer systems validation experience required.
Demonstrated experience with technical design, configuration and implementation of computerized Laboratory Systems, such as LIMS and Mirth, in a GxP environment.