Investigation & Client Quality Specialist

Position Overview

Join Thermo Fisher Scientific as an Investigation & Client Quality Specialist and become part of an exceptionally ambitious organization dedicated to making a difference. At Thermo Fisher Scientific, you'll discover impactful work, innovative thinking, and a culture dedicated to working the right way, for the right reasons, with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe, and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Employment Details

• Employment Type: Full-time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office

Responsibilities

• Manage Deviations and Investigations related to quality issues of batches for clinical and commercial use.
• Coordinate the CAPA (Corrective and Preventive Action) system stemming from quality investigations.
• Support the preparation of periodic quality trends for Management and Corporate dissemination.
• Actively participate in Operational Excellence initiatives and projects.
• Review and manage Deviations and Investigations with other company functions to determine root causes and implement corrective actions.
• Ensure the efficiency of corrective actions over time.
• Collaborate in coordinating technical and management meetings with clients.
• Participate in client visits, quality inspections, and regulatory audits.

Requirements

• Proven experience in quality management and investigation processes.
• Strong collaboration skills to work with Compliance colleagues and support various functions.
• Ability to generate detailed reports related to quality events.
• Excellent communication skills to provide customer support and train personnel.
• Competence in preparing Quality Agreements (QATs) and negotiating quality sections of contracts.
• Expertise in handling GMP (Good Manufacturing Practice) batches and supporting Readiness and Business Unit (BU) processes.

Company Information

Thermo Fisher Scientific is the world leader in serving science. Make your mark with Thermo Fisher Scientific and join our mission to make the world healthier, cleaner, and safer!