Quality Assurance Specialist III

5 dagen geleden

Tilburg, Noord-Brabant, Nederland Thermo Fisher Scientific Voltijd
Job Summary

We are seeking a highly skilled Quality Assurance Specialist III to join our team at Thermo Fisher Scientific. This is a key role that will lead and participate in cross-functional meetings to conduct root-cause analysis and determine corrective and preventative actions.

Key Responsibilities
  • Lead and participate in cross-functional meetings to conduct root-cause analysis and determine corrective and preventative actions
  • Generate and close CAPAs, Changes, and Deviations, including re-training, SOP revisions, and implementation of new processes within the site
  • Identify recurring events and trends within site deviations and propose continuous improvement ideas based on findings
  • Assist in the creation, implementation, and maintenance of training curriculum, as well as the launch of learning-based training elements for personnel
  • Support the site in maintenance of audit readiness
  • Perform gap analysis to new and existing regulations and standards
  • Partner cross-functionally to implement process improvements and participate in cross-functional projects
  • Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability
  • Recognize, understand, and respond to situations requiring further evaluation and report these events to area management
Requirements
  • Bachelor's degree and 2 years of related work experience in a pharmaceutical work environment
  • Proven track record of collaboration across the business
  • Strong analytical and problem-solving skills, with great attention to detail and excellent decision-making process
  • Expertise in handling small and medium technical and/or capital projects
  • Proven ability to present ideas persuasively and negotiate effectively
  • Excellent written and oral communication skills, both internal and external
Physical Demands
  • Ability to function in a dynamic environment and balance multiple priorities simultaneously
  • Ability to learn new software and tools quickly
  • Ability to make decisions and work with minimal to moderate supervision
  • While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time

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