Immediate opening for Business Analyst with SAP and GxP Life Sciences || Cambridge, MA || Contract

 

Hi,

My name is Saurabh, and I am a Staffing Specialist at Stellent it. I am reaching out to you on an exciting job opportunity with one of our clients.

 

Title: Business Analyst with SAP and GxP Life Sciences

Location: Cambridge, MA (Hybrid)

Experience: Min 10+ Years

Contract: Long-term

 

 

 

Note: Candidate must have Experience in BioPharma/Pharmaceutical Client In past.

 

Job Description:-

– Gathers, analyzes and manages technical business requirements, software testing (UAT, IQ, OQ), creating and writing SOP’s

– Creates and tests processes

– Authors

— Complex business requirements, including diagrams as needed

— Standard operating procedures

— Software test cases, scripts and reports, included but not limited to UAT, IQ, OQ

— IT validation documents for hardware and software

— Additional documentation upon request

– Manages document review and approval workflows

– Performs system administration duties as needed to support the implementation, configuration, setup and validation of GxP hardware and software

 

Requirements

– Core Experience

— 10 years’ experience gathering business requirements, software testing (UAT, IQ, OQ), creating and writing SOP’s

— 5 years’ experience with GXP validation documentation (including IT System Administration Work Practices) in a life science setting

— 5 years’ experience implementing SAP modules, including integrations with other software

— Thorough understanding and experience with document review and approval workflows, data archiving, and global electronic document management systems

— Demonstrated history of writing and executing test scripts and authoring test reports, manually and in MS ALM

— Proven success as a business systems analyst, working in a GxP environment

— Aptitude for creating and nurturing trusted relationships with colleagues from the IT and business teams and third-party vendors

— Demonstrated knowledge and experience working as a system administrator on Windows workstations/servers reviewing system logs, services, and settings with asset lifecycle management and environmental monitoring systems

— Proven knowledge and experience in data and server management strategies and policies

— Solid understanding of and experience with Agile, Scrum, and Kanban concepts

— Excellent oral and written communication skills

— Ability to negotiate and persuade at all levels of the organization

— Strong presentation skills

– Major Pluses

— Experience with OpenLab and Veeva Quality Docs

 

Accountabilities

– Manages document creation, review, and approval for GxP and non-GxP systems including 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 (GMP, GxP)

— Establishes and nurtures relationships with relevant colleagues from the IT and business teams

— Learns and becomes proficient in relevant IT processes, e.g., Change Management, Technical Operations, Lab Technical Support

 

Work Environment

Hybrid work environment where team members work from home and come into the office at least several times each month for meetings and working in the labs.