Quality Systems Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

The Quality Systems Specialist will drive ongoing delivery of the QSS team’s goals whilst also providing support to development and execution of the Horsham site training program and facilitating continuous improvement. These responsibilities are critical in maintaining the health of the FCS Horsham and Crawley sites’ Quality Management System (QMS) and continued compliance with GxP requirements. The position plays a vital role in enabling quality-driven improvements and ensuring the timely and efficient release of batches to support uninterrupted patient supply.

Position Summary & Key Responsibilities:

Management of the eQMS

• Support the execution of electronic QMS processes, including:
  • Review and approval of investigations, CAPAs, Change Controls, Action items and Effectiveness Checks.
  • Monitoring and driving timely completion of site QMS activities.
• Generate datasets related to Key Performance Indicators (KPIs) and trend analysis to allow for short and long-term strategic planning.
• Facilitate and lead meetings related to QMS activities.
• Provide a key point of contact for resolving end-user queries.
• Administrate the eQMS and contribute to global system-enhancement initiatives.

Execution of site training program

• Develop and deliver Horsham and Crawley site training content and associated documentation.
• Maintain and manage training records within the Learning Management System (SuccessFactors), ensuring data accuracy, completeness, and audit readiness.
• Support functional area ownership of new and existing training programs.

Continuous Improvement & Collaboration

• Collaborate with global and cross-functional teams to align local practices with global strategies and standards.
• Author related procedures, standards, and documentation in line with compliance requirements.

• Participate in site management review activities and improvement projects.
• Provide support during client and regulatory audits by preparing documentation and responding to information requests.
• Support broader QMS-related activities such as risk assessments, gap analyses and new product introduction.
• Promote a positive quality culture through knowledge-sharing and user engagement.

How will you get here-

• Demonstrate behaviours in line with the Thermo Fisher Core Competencies and 4i Values.
• Take ownership, accept responsibility for your actions and always make sound decisions with solid communication skills. 
• Demonstrate an adaptive and flexible work style shown to be effective working across varied types of clients, senior level leaders and front-line team members.
• Ensure compliance with cGMP, Quality Systems and training requirements are met in line with
  business need.

Hybrid working and flexible working available