QA Specialist II

Descripción del trabajo

Key Responsibilities

• Independently conduct, complete, and document major and minor deviation investigations related to GxP operations.
• Support critical deviation investigations with guidance from management or senior investigators.
• Facilitate cross-functional meetings to align on root cause analysis, impact assessments, and CAPA development.
• Apply root cause analysis tools to identify issues and propose effective corrective and preventive actions.
• Collaborate with internal clients and operating entities to ensure follow-up on quality issues.
• Perform activities to ensure compliance with applicable regulatory requirements.
• Maintain programs and processes to ensure high-quality products and compliance with cGMP standards.
• Manage and track quality system records (e.g., deviation reports, CAPAs, effectiveness checks).
• Maintain tracking tools and databases; send periodic reminders to leads/coordinators.
• Support management review processes by generating quality system metrics and trending data.
• Contribute to the maintenance and improvement of quality systems processes.
• Participate in the development of training programs related to quality product production.
• Participate in compliance audits as needed.
• Write and implement changes to controlled documents (e.g., SOPs, specifications, methods).
• Provide guidance and technical expertise to junior staff and monitor daily task performance.

Basic Qualifications

• BS or BA in a relevant field with 4+ years of experience in a GMP environment, or
• MS in a relevant field with 2+ years of experience.
• Working knowledge of current Good Manufacturing Practices (GMPs).
• Proficiency in Microsoft Office applications.
• Strong verbal, technical writing, and interpersonal communication skills.

Preferred Qualifications

• Prior experience in the pharmaceutical industry.
• Familiarity with QA systems principles, FDA/EMEA standards, and quality systems.
• Knowledge of Six Sigma, LEAN, and root cause analysis tools.
• Experience in audit and investigation processes and report writing.
• Ability to interface effectively with manufacturing, distribution, and maintenance functions.