Principal Quality and Training Analyst

Thermo Fisher Scientific • Morrisville, NC

5d • Onsite

About The Position

Assists with coordination of training and/or quality programs and activities. 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

• Must be able to successfully navigate and operate in a fast-paced detail-oriented environment.

Nice To Haves

• Previous experience supporting Risk Evaluation and Mitigation Strategy (REMS) programs.
• Familiarity with REMS requirements, regulated processes, and associated training and compliance activities.

Responsibilities

• Coordinate training and/or quality programs and activities.
• Schedule training for new employees.
• Identify training gaps.
• Assist with developing and delivering training programs and curriculums.
• Perform limited scope/non-clinical quality reviews of staff customer interactions and associated documentation.
• Assist with corrective action plans.
• Support 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.
• Support the operations team as a liaison with the client for training and/or quality topics.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: No Education Listed