Business Analyst - Quality and Regulatory

Thermo Fisher Scientific   •  

Rochester, NY

Industry: Professional, Scientific & Technical Services


5 - 7 years

Posted 42 days ago

How will you make an impact?

This position is part of the IT Global Operations team supporting the Quality and Regulatory business related systems. These systems are critical to the daily operation of the business to ensure regulatory compliance requirements are adhered to. This team and position are highly visible where there will be ample opportunities to make an impact. The selected candidate will have particular focus on quality systems needs within the Laboratory Products division. He or she will have the opportunity to assist the team in various capacities, including system design, development, enhancement and deployment work as well as routine production support. This person will also lead IT systems development and deployment projects, implement systems solutions to meet the Quality and Regulatory groups’ requirements, and facilitate communication between the Quality and Regulatory groups in the business and IT.

We are looking for a driven individual, with a proactive personality who is willing to go the extra length to surpass the expectations of our customer (Quality, Regulatory and GMP Manufacturing Business). Prior experience in quality management systems, regulatory systems, and GMP manufacturing is required.

The candidate should have at least 3 years of full-lifecycle implementations with quality systems. He or she should possess a good understanding of how quality systems work with ERP’s.

What will you do?

  • Conduct and/or participate in requirements gathering and design workshops
  • Develop high level design and coordinate with team members to implement solutions
  • Create and execute test scripts, capture defects, verify fixes and report updates
  • Coordinate and perform functional, end-to-end, regression, validation, and smoke testing
  • Troubleshoot issues, identify problems and develop practical solutions
  • Develop change and release documentation and assist business with training material development
  • Support change management processes
  • Contribute to knowledge repository

How will you get here?


  • Bachelor’s degree in Computer Engineering, Computer Science, Information Technology, Industrial Engineering, Systems Analysis or closely related field of study.


  • 5+ years successfully working as a business analyst or related experience on medium to large scale projects supporting quality and regulatory functions
  • Strong knowledge of IT systems validation processes and requirements
  • 3+ years of experienceworking with QMS and GMP systems
  • Experience with GMP and Quality requirements in manufacturing
  • Proven track record of capturing solid requirements that meet business needs and set the foundation for designing high quality, flexible, scalable and maintainable solutions
  • Understanding of software development life cycle (SDLC)
  • Demonstrated ability to manage quality projects including system upgrades and site deployments
  • Experience with Documentum and document management systems
  • Experience with TrackWise
  • Experience with Agile PLM
  • PMP certification
  • QMSexperience

Knowledge, Skills, Abilities

  • Ability to handle multiple tasks and proactively manage tasks to completion
  • Strong analytical skills required, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements
  • Ability to navigate complex multi-functional environments across multiple business units, be a team player and enjoy working as part of a multi-cultural team
  • Confidence and leadership ability
  • Strong written and verbal communication skills, ability to communicate technical and business information effectively to both technical and non-technical people
  • Strong analytical and problem solving skills
  • Strong presentation skills.