Principal Quality and Training Analyst

@ 56-2203444 ATP, LLC
56-2203444 ATP, LLC56-2203444atp,llc.com

Principal Quality and Training Analyst

Morrisville, NC
Posted 1 day ago

About the job

The company provides training and quality program support, ensuring compliance with policies, regulations like FDA/EMEA, and fostering continuous improvement in a fast-paced office setting.

Requirements

  • Experience with training programs
  • Knowledge of quality review processes
  • Familiarity with regulatory requirements
  • Ability to support compliance activities

Qualifications

  • Detail-oriented mindset
  • Strong organizational skills
  • Previous REMS program experience
  • Excellent communication skills

Full job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Principal Quality and Training Analyst (PQTA)-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.

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