Principal Quality and Training Analyst
Thermo Fisher Scientific
Summary
Principal Quality and Training Analyst (PQTA) - Assists with coordination of training and/or quality programs and activities.
Job description
- Schedules training for new employees, identifies training gaps and assists with developing and delivering training programs and curriculums to promote continuous improvement.
- Performs limited scope/non-clinical quality reviews of staff customer interactions and associated documentation and assists with corrective action plans if needed.
- Supports program compliance with corporate, departmental and client policies and procedures including SOPs and applicable health authority regulations (e.g. FDA, EMEA), as well as standard inquiry management and documentation practices.
- May support the operations team as a liaison with the client for training and/or quality topics.
Previous experience supporting Risk Evaluation and Mitigation Strategy (REMS) programs is highly desired, including familiarity with REMS requirements, regulated processes, and associated training and compliance activities. Must be able to successfully navigate and operate in a fast-paced detail-oriented environment.
Requirements
- Experience supporting Risk Evaluation and Mitigation Strategy (REMS) programs
- Familiarity with REMS requirements, regulated processes, and associated training and compliance activities
- Ability to navigate and operate in a fast-paced detail-oriented environment
- Knowledge of SOPs and applicable health authority regulations (e.g. FDA, EMEA)
- Experience with standard inquiry management and documentation practices
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.