Regulatory Compliance Specialist

2 months ago

Swindon, Swindon, United Kingdom Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly motivated and detail-oriented Analytical Quality Control Specialist to join our team at Thermo Fisher Scientific. As a key member of our quality assurance team, you will be responsible for ensuring the quality and integrity of our products and processes.

Key Responsibilities
  • Quality Control and Assurance: Perform quality control analytical testing of incoming goods, intermediates, and/or finished products under cGMP conditions for QC release or as part of stability studies.
  • Technical Transfer and Method Development: Conduct technical transfer/method development/method validation as required.
  • Documentation and Reporting: Prepare technical documentation, including analytical write-ups, standard operating procedures, specifications, investigations, and reports.
  • Equipment Maintenance and Troubleshooting: Perform planned preventative maintenance and performance calibrations on equipment, and provide technical troubleshooting and problem-solving related to analytical equipment, analytical methods, or unexpected results.
  • Training and Communication: Maintain own training records and support and train other team members as required, and communicate effectively with others on site and internationally.
  • cGMP Compliance: Ensure cGMP is applied and followed in all areas of the business, and participate in continuous improvement activities looking for further opportunities to progress the team/department.
Requirements
  • Education: Degree in Chemistry or strongly related scientific discipline.
  • Experience: Experience of instrumental and traditional analytical techniques, and ability to work to critical timelines with the ability to commit to overseas travel as part of a project team.
  • Skills: Strong ability to build positive working relationships with both internal and external business customers and clients, highly motivated and detail-oriented individual with excellent communication, computer, and organizational skills.

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