Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific team, 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.
Join our team as an Investigation & Client Quality Specialist and be part of an exceptionally ambitious organization dedicated to making a difference!
Responsibilities:
- Manage Deviations and Investigations related to quality issues of batches for clinical and commercial use.
- Coordinate the CAPA 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 QATs and negotiating quality sections of contracts.
- Expertise in handling GMP batches and supporting Readiness and BU processes.
Make your mark with Thermo Fisher Scientific and join our mission to make the world healthier, cleaner, and safer!
