Functional Business Analyst (GxP)

Job Description: Responsibilities •Client facing functional Business Analyst (BA) for the Seagen IT organization •GxP lifecycle documentation creation and implementation •Liaise between IT and business functions? •Work collaboratively with cross functional teams, including vendors? •Able to translate strategies into overarching execution approach •Able to translate business needs to functional and technical requirements •Able to translate customer context / discussion into customer journey information •Author requirements, process models, testing, and operational readiness documentation •Own testing documentation and activities? •Collaborate in planning and creating go-live documents •Actively collaborate with the program and project teams •Communicate risk, issues, and formulate viable mitigation plans •May be assigned GxP and SOX efforts •May participate in Change Management activities •May create technical architecture and integration documentation? Preferred Qualifications •Experience working on agile teams within Research and Development defining and supporting build of custom software solutions in an GxP environment •Experience working in a regulated environment such as GxP •Familiar with working in a Waterfall and Agile environment •Understanding of global regulatory considerations and their impacts processes, approach, and delivery •Demonstrated technical understanding of application architecture including various technology flavor and complexity such as SaaS solutions, web applications, repositories, relational databases, and reporting •Authored functional and technical artifacts such as process map, data map, data flow, and entity relation diagram, etc. •Ability to work independently with minimal supervision and direct work if necessary •Ability to interface and influence stakeholders at different level of the organization •Working understanding of IT interactions across one or more business functions •Ability to proactively plan, organize, deliver with limited oversight, prioritize, and quickly adapt to changing situations Qualifications •5+ years in a Business Analyst role with proven experience with technology delivery in Finance •3+ years in program development, oversight, and implementation •5+ years in authoring requirements, testing, and operational readiness documentation •5+ years in working as part of a program or project team •Excellent verbal and written communication skills •Proficient in essential tools such as Microsoft Project, PowerPoint, Visio, etc. Required Skills : GxP experience, R&D/lab experience Basic Qualification : Additional Skills : Background Check :Yes Notes : Selling points for candidate : Project Verification Info : Candidate must be your W2 Employee :Yes Exclusive to Apex :No Face to face interview required :No Candidate must be local :No Candidate must be authorized to work without sponsorship ::No Interview times set : :No Type of project :Assessment/Analysis Master Job Title :Bus. Analyst: Functional Branch Code :Seattle

Created: 2024-11-05