Laboratory Systems Analyst or (LSA) - Laboratory Information Management (LIMS) Systems works with IT and laboratory staff to ensure the successful and compliant operation of enterprise and site LIMS systems and any associated LES/ELN software systems.
Duties may include the configuration of software/hardware, specification management, analysis management, managing of system changes, making system configuration changes, writing/configuring reports and queries, writing system documentation, performing system testing, training of laboratory staff, responding to user requests, troubleshooting, or other duties which may be assigned.
LSA - Laboratory Information Management (LIMS) Systems Analyst is expected to be skilled in LIMS (Sample Manager, LabWare, StarLIMS or similar) and to maintain technical expertise as the system evolves and interfaces to other systems are developed. Experience with LES/ELN software is a plus.
Candidate should be a quick learner, motivated, and a team player
Essential Duties and Responsibilities:
Support all necessary aspects of LIMS projects and operations as assigned to support 24x7 operations with 99% availability
Maintain LIMS static data such as user matrix, specifications, analysis, stability protocols, data tables and instruments
Partner with IT and laboratory organizations, support users by responding to change requests and training needs
Perform system setup and configurations, including report development as necessary
Assist in interfacing of LIMS/ELN software to instrument systems
Assist in developing and maintaining Standard Operating Procedures (SOPs) for global and local Laboratory Information Management (LIMS) Systems and LES/ELN laboratory solutions
Act as key project team member for new systems implementations and/or installation of new capabilities
Provide system oversite activities including audit trail reviews, system reviews, resolution of problem reports, data maintenance as applicable
Bachelor’s degree in a science, engineering, IT or related field
Three years’ experience in laboratory systems, preferably in a pharmaceutical or other FDA-regulated environment. Experience with a LIMS system (Sample Manager, LabWare, StarLIMS or similar) and LES/ELN experience
Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance.
General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations
One or more of the following skill areas or experience: GAMP, relational database development/design, computer systems validation in an FDA regulated environment.
Special Instructions or Work Requirements:
Employee will be required to enter and exit GMP manufacturing, laboratories and QA/QC process areas with or without controlled substances
10% Support LIMS projects at Impax sites
Valid Driver's License Required
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