Quality Systems Support Senior Associate (Hybrid)

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Hybrid working: 1-2 days per week on site. Flexible working hours.

DESCRIPTION:
The jobholder will be responsible for supporting the Quality Systems Support (QSS) team in managing the execution and documentation of activities critical to the ongoing health of the TFS Horsham sites Quality Management System (QMS) and maintaining site compliance with GxP requirements. The jobholder will also take key responsibility for performing data analysis activities and creating / presenting associated reports to enable the business to drive quality-focused continuous improvement initiatives.

Key Responsibilities:
eQMS Management & Quality Systems Oversight
Support the ongoing management and administration of the electronic Quality Management System (eQMS) ensuring effective execution of quality processes and compliance with applicable standards.
Review and approve investigations CAPAs Change Controls Action Items and Effectiveness Checks.
Monitor and drive the timely completion of assigned QMS activities and site quality records.
Serve as a key point of contact for resolving system- and process-related end-user queries.
Support eQMS development administration and continuous improvement initiatives including participation in global system enhancement projects.
Assist in the construction and delivery of user training materials and presentations to promote effective system use.
Quality Metrics Data Analysis & Reporting
Conduct trend analysis and interpretation of quality metrics to identify recurring issues establish root causes and drive continuous improvement opportunities.
Perform data analysis and develop visualizations for local global client and management quality presentations.
Generate datasets and reports to support short- and long-term strategic planning and decision-making.
Continuous Improvement & Compliance
Participate in site management review activities and continuous improvement projects.
Collaborate with global and cross-functional teams to align local practices with global quality strategies standards and harmonization initiatives.
Author and maintain quality procedures standards and related documentation in accordance with regulatory and compliance requirements.
Facilitate and lead meetings related to Quality Management System activities.
Provide support during client and regulatory audits including preparation of documentation and responses to information requests.
Quality Culture & Team Support
Promote a positive quality culture through knowledge sharing user engagement and continuous learning initiatives.
Provide guidance and support to Quality Systems Associates under the direction of the Quality Systems Team Leader.
Undertake additional projects and responsibilities as required to support Quality Systems objectives and broader business goals.

How you will 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.