QA Specialist II - Remote

Overview

As a QA Specialist II at Gilead, you will play a critical role in ensuring compliance with regulatory requirements and maintaining high-quality products within a collaborative environment focused on healthcare innovations.

In Short

• Conduct and document deviation investigations related to GxP operations.
• Facilitate cross-functional meetings for root cause analysis and CAPA development.
• Ensure compliance with regulatory requirements and cGMP standards.
• Manage quality system records and track quality metrics.
• Participate in compliance audits and write controlled documents.
• Provide guidance to junior staff and monitor task performance.
• Support management review processes with quality metrics.
• Collaborate with internal clients on quality issues.
• Develop training programs related to quality production.
• Contribute to the maintenance and improvement of quality systems.

Requirements

• BS or BA in a relevant field with 4+ years of experience in a GMP environment.
• MS in a relevant field with 2+ years of experience is preferred.
• Working knowledge of current Good Manufacturing Practices (GMPs).
• Proficiency in Microsoft Office applications.
• Strong verbal and technical writing skills.
• Prior experience in the pharmaceutical industry is preferred.
• Familiarity with QA systems principles and FDA/EMEA standards.
• Knowledge of Six Sigma and root cause analysis tools.
• Experience in audit and investigation processes.
• Ability to interface effectively with manufacturing and maintenance functions.

Benefits

• Eligible for discretionary annual bonus and stock-based incentives.
• Paid time off and comprehensive benefits package.
• Company-sponsored medical, dental, vision, and life insurance plans.
• Inclusive work environment with equal employment opportunities.
• Support for individual differences and diversity of thought.