wanted: Business Analyst, TrackWise Support, Lexington, MA, Contract

Business Analyst, TrackWise Support, Lexington, MA, Contract

The Business Analyst Tier-2 Support Associate will be responsible for providing support for TrackWise Quality Management System, during the upgrade of the system, 'go-live' and post 'go-live'.

The individual will be part of a cross functional project team and will:

• Ensure that the appropriate infrastructure has been requested and provisioned
• Verify the technical specifications of the infrastructure against the design specification
• Work with Infrastructure Team and QA to create and execute the Installation Qualification (IQ) for identified infrastructure components
• Work with the vendor SME and QA to create and execute the Installation Qualification (IQ) and Data Migration protocols for TrackWise
• Assist with deviation resolution
• Document, investigate, and track issues reported during execution of the IQ, Data Migration, and Performance Qualification (PQ) protocols
• Perform impact assessment and determi ne corrective and preventative actions
• Work with Quality Assurance to determine the appropriate documentation required
• Write and execute test scripts and test cases as needed
• Implement corrective and preventative action where needed
• Assist with user training
• Perform knowledge transfer post 'go-live'

To be successful the candidate should have experience supporting TrackWise systems in the Life Science industry and be familiar with FDA regulations and industry standard related to computer systems validation GAMP. The successful candidate must have excellent communication skills, a strong technical background, problem solving skills, interpersonal skills, and above all be customer focused. Experience with Empower, Learning Management System (LMS), WinNolin, AERS, SLIMStat and Laboratory based systems will be a plus.

Minimum Basic Qualifications:

• A Bachelors' degree in Computer Science, Engineering, Life S ciences, or related discipline
• A minimum 3-5 years of supporting the TrackWise System in the Life Science Industry

Preferred Qualifications and Experience:

• Knowledge of Quality Management Systems (QMS)
• Strong technical skills
• Knowledge of GAMP V Lifecycle and 21 CFR - Part 11
• Knowledge of infrastructure qualification, VMware, Windows Server 2003, Linux, and Oracle
• Strong verbal and written communication skills

Competencies:

• Self-Management
• Customer Focused
• Problem Solving
• Team Oriented
• Interpersonal skills