Analyst II, Laboratory Instrument Systems
Position Summary:
Laboratory Systems Analyst or (LSA) – Laboratory Instrument Systems works with IT and laboratory staff to ensure the successful and compliant operation of site laboratory instrument systems and software used by quality and R&D at Impax Laboratories sites. LSA – Laboratory Instrument Systems shall cross-functionally collaborate and support other Global Quality and R&D Laboratory Systems support group team members and LSAs as required.
Duties may include the configuration of instrument software/hardware, managing of system changes, making system configuration changes, writing/configuring reports, writing system documentation, performing system testing, training of laboratory staff, responding to user requests, troubleshooting, or other duties which may be assigned.
LSA – Laboratory Instrument Systems is expected to be experienced in general pharmaceutical quality control analytical laboratory instruments including fundamental understanding and or experience with Chromatography systems, Balances, FTIR, NIR, Dissolution apparatus, Titrators, Malvern systems, UV Vis, Melt point apparatus, Polarimetry and Capillary electrophoresis.
LSA – Laboratory Instrument Systems shall partner with the IT – Quality and R&D Laboratory Systems team supporting the infrastructure and hardware for Laboratory Instrument systems, Lab Instrument Networking, BUS – LAC/E boxes, hubs or interfaces to LDS, CDS, SDMS and or LIMS systems.
Candidate should be a quick learner, motivated, and a team player.
Essential Duties and Responsibilities:
Support all necessary aspects of Laboratory Instrument Systems projects and operations as assigned to support 24×7 operations with 99% availability
Act as key project team member for new Laboratory Instrument System implementations and/or installation of new capabilities
Partner with IT and laboratory organizations, support users by responding to change requests and training needs
Perform Lab Instrument system hardware/software setup and configurations, including report development as necessary
Assist in interfacing of Laboratory Instrument Systems to other Laboratory and Lab Informatics systems
Maintain Laboratory Instrument Systems data, user matrix, performance and instruments as required
Assist in developing and maintaining Standard Operating Procedures (SOPs) for global and local Laboratory Instrument Systems
Provide system oversite activities including audit trail reviews, system reviews, resolution of problem reports, data maintenance as applicable
Qualifications:
Bachelor’s degree in chemistry, science, engineering, IT or related field
At least two years’ experience with a mix of typical pharmaceutical QC analytical or R&D Laboratory Instrument systems and equipment in an FDA-regulated environment
Experience and fundamental understanding of Chromatography systems, Balances, FTIR, Dissolution apparatus, Titrators, Malvern systems, UV Vis, Melt point apparatus, Polarimetry and Capillary electrophoresis
Experience with LIMS, LES/ELN software is a plus
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
TRAVEL REQUIREMENTS
10% Travel in support of Laboratory projects
Valid Driver's License Required
