Sr. Business Analyst
Stark Pharma Solutions Inc
- USA
- Permanent
- Full-time
Location: Boston, MA (Onsite)
Experience Required: 4 7 years Position SummaryWe are seeking a Sr. Business Systems Analyst (LIMS) to support our Cell and Gene Therapy (CGT) operations at the VMC site. This role is responsible for managing, creating, revising, reviewing, and approving LIMS master data within Lab Vantage LIMS in a GxP-regulated environment. The analyst will serve as a key point of contact for end-user support, stakeholder management, compliance with global policies, and ensuring effective execution of LIMS master data processes including EMUM. Key ResponsibilitiesPartner with site leaders to identify, capture, and update all LIMS master data across VCGT @ VMC site for GxP operations.Lead QC, QA, and Manufacturing teams in building, revising, reviewing, and approving LIMS master data such as products, sampling plans, specifications, methods, sample points, and LES templates.Provide first-line end-user support for LIMS-related issues including LES templates, data entry, COA generation, and EMUM data modules.Support the development, enhancement, and implementation of master data request, review, and revision processes.Assist with scheduling and tracking EMUM master data at the site level.Work closely with the LIMS Administrator and Business Owner to maintain site and global LIMS compliance.Contribute to the development and revision of SOPs and provide end-user training.Gather digital platform business requirements, document user stories/use cases, and support UAT as required.Act as a superuser for digital platforms, coordinating with SMEs to align business needs.Mentor junior specialists, troubleshoot technical issues, and guide them in collaboration with technical leads.Maintain master data modules, perform impact assessments, and implement change control actions.Configure instruments, consumables, and critical reagents in the LIMS system. Minimum QualificationsBachelor s degree in Technology, Science, or related field (advanced training in biology, data analysis, statistics, or data science preferred).2 4 years relevant experience in Life Sciences or equivalent combination of education and experience.Minimum 3 years of direct experience with Lab Vantage LIMS master data and system functionality.Familiarity with Environmental Monitoring and Utility Monitoring programs in a GxP pharmaceutical manufacturing environment.Understanding of regulated systems and validation processes.Strong experience with GxP laboratory, manufacturing processes, and non-GxP research/analytical development.Proven ability to manage multiple concurrent projects.Strong attention to detail and organizational skills.Excellent verbal and written communication skills.Proficiency in data analysis, data management, and master data management in Lab Vantage LIMS.