Quality Systems Coordinator
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Job Location:
Northumberland - UK
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)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.
DESCRIPTION:
Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific this role youll ensure compliance with GMP standards FDA regulations and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams youll implement continuous improvement initiatives conduct investigations and maintain quality management systems that enable our mission of making the world healthier cleaner and safer.
Responsibilities:
Subject Matter Expert and System Super User for Quality Management systems (Trackwise and Master Control).
Prepare and deliver Quality System and GMP Training
Provide QMS support to internal and external customers
Conduct internal audits
Coordinate and host External audits
Support the network document control administration functions
Lead investigations and manage assigned responsibilities within the Quality Management Systems
Provide quality system support to the quality and operations teams on products processes and investigations
Assist with quality system data analysis and Quality system review meetings focusing on quality management systems (problem notifications deviations non conformances audits)
Support the continuous improvement program to drive quality safety and process improvements
REQUIREMENTS:
Significant experience in a quality assurance/systems or technical role
Knowledge of cGMP regulations ISO standards (9001/13485) and international regulatory requirements
Experience with quality management systems and documentation (TrackWise Master Control or equivalent)
Experience in deviation investigations CAPA change control and root cause analysis
Proficient in Microsoft Office suite and quality management software systems
Technical writing and documentation skills
Analytical and problem-solving abilities
Clear verbal and written communication skills
Ability to work independently and collaboratively in cross-functional teams
Experience conducting internal audits and supporting external regulatory inspections
Project management and organizational skills
Ability to work in cleanroom environments and follow gowning procedures where required
Required Experience:
IC
Key Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
