LabVantage LIMS Business Analyst

LabVantage LIMS Business Analyst – (Remote w/some local onsite) – Los Angeles, CA A Pharmaceutical organization seeks a Business Analyst with extensive LabVantage (v8) expertise located in the Los Angeles area for a remote year-long travel with some local onsite. This person must have 5+ years analyzing business requirements in support of LIMS, with expertise in Lab Automation projects involving enterprise systems and lab equipment integrations. Additionally, this person should have familiarity with analytical methods like Cell Based, Binding and Microbiological Assays, HPLC, ELIS or others. Expertise within a GMP environment is also required along with strong documentation expertise to include technical writing. LabVantage process experience in sample management, batch release, stability, and lab execution are also required. Opportunity offers a long-term contract with potential extensions. Requirements • Reside local to Los Angeles with an ability to travel to multiple local locations as needed. • Experience in Lab Automation to include enterprise systems and lab equipment integrations. • Familiarity with analytical methods like Cell Based, Binding and Microbiological Assays, HPLC, ELISA and other routine analytical assays. • Strong experience in quality management systems and regulatory compliance to include areas of sampling, pharmaceutical QC, lab data and reports (C of C/C of A), data management, change control and GLP/GMP. • Expertise in technical regulatory writing, to include writing and editing detailed requirements, user stories, business processes, technical specifications, test protocols and reports, for both custom and commercial off-the-shelf systems. • Familiarity with CSV and GxP processes. • Expertise supporting multi-site enterprise systems regarding master data to include LIMS, MES, and PLM. • Experience in LabVantage processes within sample management, batch release, stability, and lab execution. Responsibilities • Working with all levels of Quality, Manufacturing, Vendors and IT to ensure project delivery and timelines are met. • Interaction with Lab Operations Group in the support of LabVantage LIMS implementation and ongoing new module implementations, installations or new capabilities. • Managing and delivering IT projects throughout organizational digital systems to include involvement in URS, FRS, Design Specifications, UATs, Validation (IQs, OQs, PQs) and Deployment Support; writing, editing, and updating all documentation surrounding these. • Participation in all phases of application implementations. • Assisting in the development of SOPs for global and local LIMS. • Working with IS and IT to integrate LIMS within a cGMP environment. • Partnering with IT and Lab groups to respond accordingly to change requests and training needs. • Working collaboratively in the analysis of complex master data and custom configurations for LIMS. • Identifying and recommending areas of process improvement. • Performing knowledge transfer, while providing ongoing leadership in the support of project go-live, operations and other activities. Benefits • A year-long contract that is primarily remote. • Ability to work as a W2 paid employee with or without benefits, or 1099 consultant.