Sr. Business Systems Analyst

Working in a pharmaceutical environment, the Business Systems Analyst will implement and support information technology systems supporting R&D, Manufacturing, and Quality groups. Responsibilities include:

• Provide technical expertise in applications support, project management, and process re-engineering techniques to drive project implementation to be on time, on budget and delivery of a quality solution.
• Work within computer validation / qualification guidelines.
• Provide suitable IT solutions to meet business requirements and needs.
• Support laboratory instrument workstations and applications (FTIR, UV-Vis, DSC, GC, MS).
• Support quality systems (Calibration, CMMS, CAPA, EDMS, LIMS, CDS).
• Assist with implementation and support of new applications.
• Complete; maintain all documentation on all new systems.
• Identify problems, perform analysis and provide solutions.
• Gather user requirements aligned with existing or emerging business processes by working with business users and key stakeholders.
• Develop system strategies, implementation plan, and budgets.
• Following system development life cycle and complete deliverables in a timely manner.
• Partner with global IT and ensure IT projects are in line with business objectives.
• Provide communication on task status to senior management.
• Partner with IT Quality Manager to ensure projects and activities are compliant with FDA and other regulatory requirements/internal polices/processes.
• Support the creation and interfacing of applications to the IT architecture and stay current with technology trends.
• Ensure cGMP and compliance requirements are met and/or exceeded on designated activities.
• Complete service requests / activities as assigned.
REQUIREMENTS
BS in Computer Science, Information Systems, or Scientific discipline is required. 8 years of industry work experience and a minimum of 5 years systems implementation and analysis experience for Analyst III, 10 years industry experience for Senior Business Systems Analyst. Experience working in a GMP pharmaceutical manufacturing environment is a must. Candidates must have experience in implementing and supporting lab systems (instruments and applications). Experience with support of laboratory instrument workstations and applications (FTIR, UV-Vis, DSC, GC, MS). Experience with support of quality systems (Calibration, CMMS, CAPA, EDMS, LIMS, CDS). Hands on experience in Windows XP, NT configuration and the use of imaging tools. Ability to manage multiple projects/solutions for multiple business requestors. Experience in assessing end-user issues and requirements and demonstrated ability to resolve and integrate technology solutions. Experience in performing business systems analysis and assessing organization-wide impacts of application or process changes.