Project Consultant Business Analyst

Published
December 5, 2017
Job Type

Description

Requisition No.: 22111-1

Status: Full Time

Project Duration: 3 months

Position Description:

This position will be located in New Brunswick, New Jersey, reporting into Quality Director, Product Complaint Management.

 

Primary responsibilities:

 

  • Assess as-is processes, technology landscape and data to identify improvement opportunities
  • Lead the business process simplification for Global Product Quality Complaints
    • Drive key business process requirements gathering from Subject Matter Experts (SMEs) across BMS sites and local markets
    • Manage project needs and engage support from SMEs globally
    • Conduct working sessions with SME for requirement definition
    • Establish project milestones and work towards targeted deliverables for each work stream
    • Manage the improvement activities through established project management tools
    • Document detailed process flows
  • Conduct functional fit-gap analysis for redesigned processes and document to-be requirements
  • Develop key deliverables of User Requirement Spec (URS), Functional Spec (FRS), validation plans, risk assessment and IQ/OQ/UAT test scripts
  • Prepare training material, system guides and Standard Operating Procedures (SOP) for the to-be system
  • Provide project updates to project stakeholders, sponsor, and management as necessary
  • Escalate issues to management in a timely manner with proposals to resolve
  • Execute validation and testing activities to qualify PQC systems in GxP environments
  • Partner with identified Change Champions for site readiness activities
  • Perform other duties within the scope of the project as assigned.

Skills Required

• Experience in consulting as a business process transformation/Solutions Architect/ Validation Lead in enterprise transformation projects with focus on Quality Management Systems within a regulated health care industry.
• Have good understanding of GxP standards, 21 CFR Part 11, System Development Lifecycle (SDLC) in hybrid agile and waterfall methodologies.
• Minimum of a Bachelor’s Degree in Engineering or life sciences is required.
• Experience in implementing quality risk management strategies within business processes is required.
• Project Management and Six Sigma certification required.

Skills Preferred

• Analyzing data and identifying issues/areas for improvement is essential.
• Ability to communicate effectively on a professional level
• This individual should have creative problem solving and critical thinking skills.
• Work with minimal supervision, engage appropriate departments, obtaining necessary information to make informed decisions and recommend solutions
• Demonstrated understanding and application of CGMPs, Quality Systems, relevant laws, guidance, and directives, and current industry practices.
• Attention to detail, ability to work and coordinate activities with multiple functional groups and with the sense of urgency
• Ability to prioritize, plan, and schedule.
• Strong oral and written communication skills,

Experience Required

This position requires minimum of 5-years of relevant experience.
• Experience in "continuous process improvement" is required
• MS Office experience is required,
• Project management experience required.
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