Investigation & Client Quality Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific Inc. is the world's largest service provider for scientific applications with annual sales of more than $40 billion and more than 130,000 employees in 55 countries.  Our mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life science research, solving sophisticated analytical challenges, improving patient diagnostics and therapeutics or growing efficiency in their laboratories, we are here to support them

Assignments, specific/primary activities:

• Handles deviations and investigations (including complaints and non-conformities in receipt of raw materials, active ingredients, and GMP materials) related to quality issues in batches manufactured for clinical and commercial use, ensuring completion within the encouraged timeframes;
• Leads the CAPA system resulting from quality investigations;
• Supports the preparation of periodic quality trends for management and corporate dissemination;
• Supports and gives to Operational Excellence initiatives/projects;
• Actively participates in all meetings scheduled for new and ongoing projects;
• Analyzes and coordinates discrepancies and inquiries across different company departments to identify the root causes and implement the corrective action plan within the timelines set by technical agreements;
• Verifies the efficiency of corrective actions over time;
• Collaborates with colleagues in coordinating technical and management meetings with customers;
• Participates in customer visits and quality inspections (audits), as well as internal and regulatory quality inspections;
• Generates reports on quality events;
• Contributes to the achievement of quality objectives for their area of ​​responsibility, as well as RFT, Deviation Rate, Past Due, and Ontime Closure objectives;
• Gives to the achievement of business/customer happiness objectives;
• Collaborates with Compliance colleagues in reviewing and drafting Quality System SOPs that fall within the scope of their Quality Unit;
• Provides customer support via telecommunications and email, responding promptly to quality questions;
• Gives to the development of FMEAs;
• Manage the drafting, archiving, and distribution of controlled company documentation;
• Provides training to personnel involved in PDS/DPS quality activities;
• In accordance with the manager's instructions and activity scheduling, leads all aspects of the drafting of QATs and their negotiation with customers, site QPs, and legal counsel.
• Serves as SME and QO contact for assigned projects, representing the quality point of reference and support for customers and internal departments to ensure the success of projects and the manufacturing/disposition of GMP batches.
• Supports the team and other functions in ensuring full support for Readiness and Business Unit processes.

Requirements:

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related scientific field
• Minimum 2 years  of experience in a similar role
• Strong knowledge of GMP/GDP principles and pharmaceutical quality systems.
• Experience in complaint handling, investigations, or quality assurance within the pharmaceutical industry.
• Excellent analytical and problem-solving abilities; ability to perform structured root cause analysis.
• Strong written and verbal communication skills in English.
• Ability to collaborate across multiple departments and manage multiple cases simultaneously.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!