Quality Assurance Specialist I

About the role

Join Thermo Fisher Scientific as a Quality Assurance Specialist I, supporting manufacturing operations across the Andean region. You will help ensure compliance with Good Manufacturing Practices and maintain high standards of product storage and distribution.

Key responsibilities

• Manage and update Standard Operating Procedures (SOPs) and related documentation.
• Support product release activities and monitor manufacturing processes.
• File, maintain, and revise quality records, batch records, and GMP documentation.
• Ensure compliance with Good Storage and Distribution Practices for the CTD Andean Region.
• Coordinate quality activities with third‑party depots in Chile, Colombia, and Peru.

Required profile

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific field.
• Minimum 1 year of experience in the pharmaceutical industry, CROs, or logistics.
• Thorough knowledge of GMP standards and local regulations.
• Ability to work independently and collaborate across functions.
• Intermediate oral and written English.

Required skills

• Good Manufacturing Practices (GMP)
• CAPA (Corrective and Preventive Action) management
• Change control processes
• Learning Management Systems
• Documentation and batch record review
• Quality Management System tools