Thermo Fisher Scientific Sr. Systems Analyst in St. Louis, Missouri

Job Description

Sr. Systems Analyst

Requisition ID: 65117BR

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

Oversee the electronic quality systems (EQS) utilized for deviations/investigations, change control, electronic document management system (eDMS), learning management system (LMS), and laboratory information management system (LIMS).

What will you do?

  • Collaborate with IT to develop new user functionality and expand existing user functionality of all EQS

  • Collaborate with IT on business requirements to ensure adequate infrastructure support

  • Provide support to IT and/or vendor on future upgrades, modifications, and other business needs

  • Collaborate with the software engineering team and QA department to perform IQ/OQ/PQ, to facilitate validation activities; develop and/or execute test scripts as required

  • Oversee and/or author the Standard Operating Procedures, User Guides, and other relevant documentation for all EQSs

  • Ensure ongoing system proficiency and provide company-wide training in respect to any changes or upgrades

  • Assist with change control impact assessments

  • Participate in internal audit reviews of the systems and system documentation

  • Recommend resources needed for proper upgrades or other maintenance functions

  • Provide high-level project management for any EQS project

  • Provide guidance to indirect reports supporting the EQSs by: leading organizational change; cultivating relationships; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

  • Ensure compliance with FDA, EMA and other cGMP regulations, including customer requirements and international regulatory requirements.

  • Effectively communicates with peers and all other departments on site.

  • Provide support to site Safety initiatives.

  • Perform any other tasks as requested by Senior Management to support Quality oversight activities.

How will you get here?

Education

  • BS or MS in a life science or engineering discipline.

Experience

  • Minimum of 6-8 years of experience in a GMP Environment required.

  • Experience with LIMS basic coding and code reviews required.

  • Experience with change control and software validation

  • Knowledge of CGMP/ICH/FDA regulations with 21 CFR Part11 and GAMP knowledge

  • Knowledge of GMP and GDP requirements.

  • Proficient in use and understanding of data systems

  • Experience in project management

Knowledge, Skills, Abilities

  • Must be able to interact and communicate effectively with other departments to meet project milestones and goals.

  • Excellent interpersonal, analytical/problem solving and written communication skills.

  • Ability to prioritize and successfully manage complex and competing projects

  • Detail-oriented with expertise in problem solving and solid decision-making abilities

  • Ability to work in a fast-paced environment to meet client and internal demands under tight timelines

  • Ability to drive functional, technical and operational excellence.

  • Ability to interact and collaborate effectively with all levels of management.

  • Proficient in Microsoft Word and Excel.

  • Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.