| Business Systems Analyst || Cambridge, MA || Hybrid at Cambridge, Massachusetts, USA |
| Email: [email protected] |
| From: Santosh, Vyzeinc [email protected] Reply to: [email protected] Job Description - JOB TITLE: CTMF Lab Equipment Business Systems Analyst LOCATION: Cambridge, MA. Job Description Authors IT validation documents for hardware and software, manages document review and approval workflows. Performs the analysis of complex business problems and manages business requirements within area of responsibilities. Authors and performs Periodic Reviews, Account Reviews, Data Integrity assessments, Audit Trail reviews as needed. Provides IT experience and guidance to provide IT solutions to complex process problems and issues. Performs system administration duties as needed to support the setup and validation of GxP hardware and software. Works with the business to define validation scope and set priorities. Leads testing efforts for GxP product/project validation efforts. Core Requirements Excellent lab equipment implementation and validation documentation skills in a GxP lab environment 10 years of hands-on experience working on and validating lab equipment, for example, NC-200, XURI (Unicorn), Met One, BACT/MYLA, FACSDiva, etc authoring and managing the end-to-end process for creating GxP validation plans authoring GXP validation documentation such as User Requirements Specs, System Design and Configuration Specs, IQ/OQ Test Packages, Traceability Matrices, Test/Validation Summary reports and SOPs, including IT System Administration Guides interfacing and liaising between all levels of IT, business and third-party vendors gathering and managing business requirements, writing test scripts, testing software (UAT, IQ, OQ), through ALM and/or manually, writing the test report and shepherd approvals through the approval process 5 years experience Understanding of key concepts and principles of data integrity and hands on experience with data management and IT audit trail reviews with lab systems nice to have Expertise in CFR Part 11/GxP software qualification. Understanding of data management for GxP lab equipment Assist in managing data integrity across lab equipment and systems, as well as enterprise systems Data resiliency backup, restore, archive Audit trail review and management Performing annual account reviews, periodic reviews Assisting GMP data quality assessments and managing deviations Working knowledge of data archiving and electronic document management systems; prefer experience with OpenLab and Veeva Quality Doc to manage backup and restore processes Experience managing document lifecycle 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 for asset lifecycle management and environmental monitoring systems. Accountabilities Manages document creation, review, and approval for GxP and non-GxP equipment including but not limited to lab devices and 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 (GMP, GxP). 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 EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Required Bachelors Degree or equivalent in a scientific discipline, computer science or business administration. 10 years or more relevant professional experience as a Business Systems Analyst in Pharma/BioTech. Professional in-depth knowledge of product management in pharmaceutical industry. Experience with lab solution technologies (e.g., SAAS and standalone lab equipment). Experience with Data Integrity, Compliance activities, and CAPA/deviation management/remediation. Bring deep technical expertise and understanding of life sciences lab equipment/solutions products and technologies Familiarity working in a lean and agile software delivery team; managing a robust and fluid backlog of work in Jira. Experience in stakeholder relationship management and product teams to turn product vision into reality/workable technical solutions. Excellent oral and written communication skills, business acumen, and enterprise knowledge; extensive experience working with SDLC deliverables for Pharma/BioTech (URS, Test/Val Plans, Design and Config Specs, IQ/OQ test documents, Test/Val Summary Reports). Work with virtual/agile teams in different locations, aligning and adapting different work, culture and communication styles. Preferred Knowledge of lab of the future trends to define a robust and clear informatics strategy around management of analytical samples and experimental data within the context of a larger ecosystem of technologies, experimental workflows, advanced analytics, data sciences and a cloud infrastructure. Understanding and knowledge of current trends in AI and ML enabled solutions for Labs. Masters Degree in Computer Science or related discipline. Experience in design or in implementing solutions or products and preferable experienced in quality improvement. Accomplished practitioner of design thinking, with a proven track record of developing solutions by understanding/gaining customer insights. Experience with the design and development of pharmaceutical life science products. Employee Value Proposition (EVP) Tier 1 Pharmaceutical company. Heavy interaction with stakeholders in the business team across the globe in a highly professional consultative organization. Work Environment Hybrid work environment where team members work from home 3 days per week and come into the office for meetings and working in the labs 2 days. Days in office are flexible. Keywords: artificial intelligence machine learning information technology Massachusetts North Carolina Business Systems Analyst || Cambridge, MA || Hybrid [email protected] |
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| Tue Oct 01 03:29:00 UTC 2024 |