Quality Assurance Officer

About the role

As a Quality Assurance Officer at Thermo Fisher Scientific you will join a dedicated QA team ensuring consistent execution of quality standards and regulatory compliance in a GMP environment. You will help maintain product quality, drive continuous improvement and support our mission to make the world healthier, cleaner and safer.

Key responsibilities

• Ensure product quality and compliance with cGMP and ISO standards.
• Review and release batch records, SOPs, work instructions and related documentation.
• Investigate deviations, non‑conformances and manage CAPA processes.
• Support internal audits and external regulatory inspections.
• Collaborate with cross‑functional teams to implement continuous improvement initiatives.

Required profile

• Bachelor’s degree in Chemistry, Biology, Biotechnology, Engineering or related scientific/technical field.
• 2‑3+ years experience in a GMP‑regulated or quality‑controlled manufacturing environment, preferably in pharmaceutical, biotech or medical‑device sectors.
• Working knowledge of cGMP requirements and ISO 13485/ISO 9001 standards.
• Familiarity with quality systems, controlled documentation and audit support.

Required skills

• Strong attention to detail and accuracy in documentation review.
• Analytical and problem‑solving abilities for deviation investigations and root‑cause analysis.
• Experience with QMS tools such as TrackWise, SAP and electronic document management systems (EDMS).
• Knowledge of ISO 13485, ISO 9001 and cGMP regulations.