QA Specialist I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our high-performing team at Thermo Fisher Scientific, where you'll ensure quality compliance across manufacturing operations while advancing our mission to make the world healthier, cleaner, and safer. As a Quality Specialist I, you'll provide support to the Quality Assurance sector, performing support tasks in the management of SOPs, product release, monitoring of processes, filing and updating of documentation, in order to ensure that CTD Andean Region operates within standards of good storage and distribution practices, as well as the functions interconnected with the various Third Party Depot in Chile, Colombia and Peru. All these activities shall be carried out in accordance with the specifications and IT/administrative tools required by the Company and/or clients.

REQUIREMENTS:
• Bachelor's Degree required,

• At least 1 year in the area and preferably in similar tasks in the pharmaceutical industry, CROs, or similar logistics companies
• Preferred Fields of Study: Pharmacist, Chemistry, Biology, Engineering, or related scientific field.
• Thorough knowledge of GMP standards and local regulations.
• Proven ability to review and approve GMP documentation, batch records, and quality records.
• Strong understanding of quality management systems and tools (e.g. CAPA, change control, learning systems.)
• Ability to work independently and collaborate effectively across functions
• Commitment to maintaining a quality-focused culture and driving continuous improvement
• Intermediate level oral and written English.