ImmunoGen, Inc. is in search of a business analyst that will be responsible for business system analysis and technical support of Quality Information Systems in a GMP regulated environment. This role will work directly with end users and system owners and external consultants to document, analyze, and provide technical solutions to help achieve business goals. This role will ensure a high level of client satisfaction through deployment, support and maintenance of electronic quality systems.
- Collaborate with end users and system owners to document user and functional requirements, and map business process for new implementation or upgrades to processes and systems.
- Works as a team player across many functions, departments and groups.
- Coordinates quality system validation efforts by creating necessary documentation.
- Responsible for configuration of automated systems including technical support, SQL queries and creating custom reports using Crystal Reports.
- Provides system administration and day-to-day production support for quality management systems. Identifies and troubleshoots routine system problems independently or with the help of IT or vendor.
- Properly implements change controls, SOPs, policies and procedures, regulatory or compliance requirements and all relevant standards for support and maintenance of quality information systems.
- Acts as a technical lead or lead small to medium size projects. Must be independent, able to multi-task and prioritize own work, and influencing the work of others.
- Displays solid project coordination, and communication skills by taking proactive and timely action to contribute to routine and non-routine activities.
- Develop training programs and procedures for the business user community and delivers well-organized presentations
- BA/BS degree in Computer Science or related field; Minimum 6 years Information Systems related experience in biotech or pharmaceutical industry.
- Experience with business analysis of systems including, QMS, EDMS, LIMS, lab systems and application support is required. LabWare LIMS, AssurX CATSWeb or TrackWise experience preferred.
- Strong background and experience with databases, SQL programming and custom report development using crystal reports is required.
- Experience with web-based systems, server architecture, validation principles of GMP/GLP systems and 21 CFR part 11 regulations is essential.
- Demonstrated strong analytical skills applied to understanding of business operations and process improvements, requirement elicitation, use case development and system configuration.
- Strong collaborative and customer focused skills are necessary for supporting the Quality Information Systems.
- Excellent organizational skills, including the abilities to prioritize workload, work independently, and meet deadlines; detail-oriented and possessing effective listening and oral communication skills.
- Strong written and verbal communication skills.