QA Co-ordinator - Horsham, United Kingdom - Thermo Fisher Scientific

Tom O´Connor

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Tom O´Connor

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Description

When you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality and innovation.

As part of a successful, growing global organization you will be encouraged to perform at your best.

With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.


Fisher Clinical Services, part of Thermo Fisher Scientific, has an unwavering commitment to service, science, and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility, and unrivaled expertise.

We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labelling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability, and sustainability standards


Position Summary:

The Quality Coordinator working within the Facilities, Project & Engineering Department.

Will be responsible for providing support/ownership for TrackWise (Quality system) and eDMS (Document system).


Trackwise quality events (Deviations), providing assistance/ownership for working cross-functionally in writing up quality events (investigations and risk analysis), setting up an investigation team to establish root causes, and documenting outcomes.

eDMS authoring documents with the support of the document owners.

Driving continuous improvement within the department.


Key Responsibilities:


  • To be involved in investigations (Trackwise) into quality issues such as investigations and root cause and implementation of appropriate (Corrective and Preventive actions) CAPA's to correspond with the outcomes of investigations
  • To coach the team to improve investigation, document, and report writing skills.
  • Prioritising working load.
  • Working within the Department to carry out root cause analysis through analysis and interpretation of the quality metrics
  • Review and own Document Management (eDMS, archiving and document storage) and process updates for the department
  • Support department SME with control and review of the Environmental Monitoring System
  • Department SME for our Quality Management System (Trackwise) and eDMS
  • Develop and implement document storage and archiving process for the department

Minimum Requirements/Qualifications:


  • Word and Excel competent
  • Experience within Quality
  • PC Literate

Experience required of:


  • Knowledge of GMP environments
  • Collaborate especially in a matrix management organisation.
  • Ability to influence across functions across Fisher Clinical Services sites and across companies to achieve objectives
- investigation report writing skills

  • Process analysis skill suitable to collect/analyse data leading to proposed process improvement with quantifiable business benefit
  • Flexible and adaptable, with strong customer management skills
  • Able to analyse problems and define solutions
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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