Quality Assurance Leader

1 day ago


Worcester, Massachusetts, United States AbbVie Full time
Job Overview

The Senior Quality Associate II plays a pivotal role in leading the Quality Function, driving effective implementation of quality processes within operations. This encompasses Incoming Quality Assurance, Product Quality Assurance, Validation, Training, Regulatory Compliance, Quality Planning, Product Quality, and strategic initiatives.

  • Leverages influence to lead peers and colleagues within the scope of their work.
  • Responsible for various aspects of quality assurance related to products produced at the plant.
  • Independently identifies and resolves quality compliance issues.
  • Provides regulatory and technical guidance to departments.
  • Communicates with Management for Quality Management Review, Quality Initiatives, etc.
Responsibilities

Ensures compliance with AbbVie Quality Systems and cGMPs, responsible for quality decisions related to their functional area.

Qualifications

Bachelor's Degree in Physical or Life Sciences, Pharmacy, or Engineering; 8+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics; familiar with electronic document management and laboratory information management, AbbVie Quality Systems, cGMP, and other regulatory requirements; strong communication skills, both oral and written.



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