Lab Systems Business Systems Analyst
Location: Cambridge, MA (Central Sq)
Job Summary: The Lab Systems Business Systems Analyst at a major pharmaceutical company in a Cell Therapies Manufacturing Facility will be responsible for end to end validation and support of lab systems and ensure GxP compliance of systems by gathering business requirements, performing software testing, and creating validation documentation. The role involves managing data integrity, audit trail reviews, and data resiliency processes.
Key Responsibilities
- Authors IT validation documents for hardware and software, manages document review and approval workflows.
- Performs analysis of complex business problems and manages business requirements within area of responsibility.
- Authors and performs Periodic Reviews, Account Reviews, Data Integrity assessments, Audit Trail reviews as needed.
- Performs system administration duties as needed to support the setup and validation of GxP hardware and software.
- Manages document creation, review, and approval for GxP and non-GxP systems primarily but not limited to lab systems.
- Manages requirements gathering, prioritization and negotiation with business stakeholders to ensure the total solution delivered meets or exceeds expectations.
- Maintains and influences business process design; validates and interprets business needs by conducting feasibility studies and drafting business cases.
- Uses knowledge of business operations and uses Business Process Mapping to articulate business and data flows for the purpose of operational and technical improvement.
- Ensures delivered solutions are compliant with associated federal regulations.
- Establishes and nurtures relationships with relevant colleagues from the IT and business teams.
- Learn and become proficient in relevant IT processes, e.g., Change Management, Technical Operations, Lab Technical Support, Data Integrity/Compliance/CFR Part 11.
Core Requirements
- Proven success as a business systems analyst, working in a GxP environment, interfacing and liaising between IT, Business (all levels of lab staff) as well as Third Party vendors.
- Experience gathering business requirements, software testing (UAT, IQ, OQ), creating and writing SOP's and GXP validation documentation (including IT System Administration Guides).
- Expertise and experience working on and validating lab systems (for example, NC-200, XURI (Unicorn), Met One, BACT/MYLA, FACSDiva).
- Understanding of key concepts and principles of data integrity including IT audit trail reviews.
- Expertise in CFR Part 11/GxP software qualification.
- Understanding of data management for GxP systems.
- Implementing and managing data integrity across lab and enterprise systems.
- Data resiliency – backup, restore, archive.
- Audit trail review and management
- Performing annual account reviews, periodic reviews.
- Performing GMP data quality assessments and managing deviations.
- Working knowledge of data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs) to manage back up and restore requirements.
- Experience managing document life cycle workflows in Veeva Quality Docs.
- Write and execute test scripts and author test summary reports.
- Experience with Agile, Scrum, and Kanban concepts.
- Nice to have - experience working as a system administrator on Windows workstations/servers reviewing system logs, services, and settings with asset lifecycle management and environmental monitoring systems.
Qualifications:
- Bachelor’s degree in information technology, Computer Science, or a related field.
- Minimum of eight years of experience as Business Systems Analyst with a strong understanding of GxP regulations.
- Knowledge of IT infrastructure, including networks, servers, and lab systems.
- Excellent written and oral communication skills, with the ability to effectively communicate with a diverse set stakeholders.
- Strong organizational and project management skills, with the ability to manage multiple tasks and priorities.
- Ability to work independently and as part of a team, with a proactive and solution-oriented approach.
- Knowledge of cloud computing and hosting platforms, such as AWS, Azure, or Google Cloud.
- Experience with disaster recovery and business continuity planning.
- Up to date with emerging trends and technologies in the industry and practices continuous professional development.
Work Environment
Hybrid work environment where team members work from home three days per week and come into the office for two days (specific days in the office are flexible).