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Senior Specialist, Lab Systems - West Chester Ohio

Company: Resilience, Inc
Location: West Chester, Ohio
Posted On: 05/03/2024

Position Summary & Responsibilities: This position is cross-functional in nature, with a focus on customer focused lab administrator support of QC Systems ranging from enterprise database systems to local stand-alone software for control of laboratory instruments. Some of the global enterprise systems to be locally administered include Empower Chromatography Data System; LabVantage LIMS; and Novatek Environmental Monitoring Management Software. Stand-alone systems include common analytical and microbiological laboratory systems, such as those for particle size analysis; total organic carbon determination, Fourier transform infrared spectroscopy, rapid endotoxin and sterility analysis, microscopy, etc.. Position is part of a team of support. Position may specialize within one or two enterprise laboratory systems, but should expect to cross train to ultimately be able to support all systems at some level as required by customer/site demands. Position to primarily support site QC laboratories (Analytical Chemistry, Incoming Quality Control, Microbiology), as well as other site customers such as the process execution teams and Aseptic Control Team. In addition to support of systems specifically mentioned above, support of future QC systems (Enterprise or local) as identified / adopted by the business. Job Responsibilities: Works independently to provide a high level of support for site and external customers including, but not limited to: Enterprise Laboratory Systems Local Administration: Performs master/static data builds - this includes all necessary database objects/tables required for site functionality within the system. Performs required maintenance and troubleshooting activities. Performs change control activities for the local instance of the system as required. (assessments; action items; upgrades, etc..) Serve as the primary link between corporate support teams and local users. Serves as Subject Matter Expert for systems on site projects; performing project work as necessary (including validation script author/execution/review activities) Provides and follows up on ideas for continuous improvements in local administration activities and procedures. Manages local accounts maintenance, yearly audits Troubleshoots complex customer issues Review/approve master/static data created by other admins. Serves as a subject matter expert for audits; speaking to site administrative activities as necessary. Provides and follows up on ideas for continuous improvements in laboratory processes in regards to applicable systems. Responsible for maintaining connectivity for integrated instruments, hardware and peripherals/accessories (interfacing with local or global digital team, and vendors as necessary) Performs investigations as relates to maintenance/build activities/processes as necessary. Provides training to site employees on general system procedures; serves as site expert for "How To" questions. Author relevant SOPs, work instruction and forms. Local Computerized QC Systems Administrative Support: Manages/Performs account creation and maintenance, yearly audits Performs change control activities as required. (assessments; action items; upgrades, etc..) Serve as the primary link between Digital support and local users. Serve as the primary link between site and vendor software support as necessary. Performs annual maintenance activities Serves on site projects; performing project work, as necessary (could include participating in drafting/execution of validation scripts) Provides and follows up on ideas for continuous improvements in local administration activities Troubleshoots complex customer issues and escalates to Digital/Vendor Support as required. Speaks to local administrative activities in audits as required Provides and follows up on ideas for continuous improvements in laboratory processes in regards to applicable systems. Assists with investigations as required. Assist with / serve as delegate for System Owner activities. Author relevant SOPs, work instruction and forms. Minimum Qualifications: Lab experience (Micro or Chemistry) or Experience with one or more laboratory database system(s) such as a: Laboratory Information System (LIMS); Electronic Lab Notebook (ELN); Laboratory Execution System (LES); Chromatography Data System (CDS); Environmental Monitoring Management Software (EMMS) or similar. Preferred Qualifications: Bachelor's degree in a science or other technical field Some GMP experience within the Pharmaceutical Industry. Significant experience as an advanced user type (such as super user or some type of administrator) for a lab database system. Previous experience performing administrator tasks on QC instrument specific software. (IR; TOC; Particle Size Analyzer; other...) Participation on project(s) to implement new laboratory computerized system(s) This position may also include the following conditions: The items described here are representative of those that must be met successfully to perform the essential functions of this job. Employment Type: Full Time Bonus/Commission: No More...

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