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Business Analyst

3 months ago

Philadelphia, Pennsylvania, United States Saxon Global Full time
Business Analyst

Address the work will be performed: Hybrid Philadelphia

PA Target start date: 4/3

Length of contract assignment: 8 months

Work schedule/typical work week/daily start and end time:

  • 40 hours,
Mon-Fri

  • 8am to 5pm
Onsite at the Philadelphia location 3 days/week

Visa:
All

Rate:
$75/hr C2C

Client description:

  • Medium sized Biotechnology company that focuses on Cell & Gene Therapies
  • Provides R&D and Manufacturing services.
  • IT Organization is going through some changes and will now be aligned through Facilities leadership.
  • Multiple high priority IT projects in 2023 in preparation for onboarding of new client, Johnson and Johnson.

Project description:

  • Client is looking for a senior BA with GxP regulated Lab Applications/Systems experience.
  • Manage MES workstream for Implementation of a new platform
  • Will be responsible for analyzing lab apps (Discover, Documentation, Workflow) and developing the lifecycle management plans.
  • Project champion for migration of Blue Mountain RAM CMMS to the cloud
  • Engage with stakeholders on the environmental monitoring project to perform gap analysis of environmental monitoring software.
  • Support regulatory and compliance team on the migration of document management system from local version 1 to enterprise version 5.
  • Work with stakeholders and manage the examination of current lab systems and applications and determine if they are a fit for intended purposes.
  • Organize workflows and ownership of all systems currently in place.
  • Provide recommendations/guidance on which systems/applications are non-core.

Consultant's day to day responsibilities:

  • Participate in GxP validation activities (writing and reviewing protocols)
  • Discovery activities including interviewing stakeholders, SME's, vendors/suppliers.
  • Developing SOP's, training documentation, test plans and test cases.
  • Act as additional resource for current BA team supporting priority projects.
  • Lead work sessions, focus groups and vendor workshops to capture clear user requirements.
  • Work with business stakeholders to define expected outcomes and establish KPI's.

Required Skills:

  • Prior Experience as Business Analyst in the Pharma IT space, must have:
o Experience in GxP, 21 CFR Part 11 environment

o Served as the lead BA on a full life cycle implementation project.

o Served as BA on an MES project

Desired Skills

  • EBR, ELN project experience preferred.
  • Served as a BA on Building and Manufacturing Applications (Ex: Rees Scientific, ELPRO and Empower CDS.)