Quality Assurance Officer

About the role

Thermo Fisher Scientific is seeking a Quality Assurance Officer to join its GMP‑focused QA team. You will help ensure consistent execution of quality standards and regulatory compliance, supporting customers in delivering healthier, cleaner, and safer outcomes.

Key responsibilities

• Maintain product quality and drive continuous improvement initiatives in a GMP environment.
• Collaborate with cross‑functional teams to uphold the highest standards of quality and compliance.
• Review batch records, SOPs, work instructions, deviations, non‑conformances, and CAPAs.
• Support internal audits and external regulatory inspections.
• Utilize QMS tools to manage documentation and track quality issues.

Required profile

• Bachelor’s degree in a scientific or technical discipline (e.g., Chemistry, Biology, Biotechnology, Engineering).
• 2–3+ years of experience in a GMP‑regulated or quality‑controlled environment, preferably in pharmaceutical, biotech, or medical‑device manufacturing.
• Foundational knowledge of cGMP requirements and ISO standards (ISO 13485, ISO 9001).
• Experience with controlled documentation and quality systems.

Required skills

• Proficiency with QMS tools such as TrackWise, SAP, and electronic document management systems (EDMS).
• Working knowledge of cGMP, ISO 13485, and ISO 9001.
• Experience reviewing batch records, SOPs, and work instructions.
• Ability to investigate deviations, manage non‑conformances and CAPAs.
• Support of internal audits and external regulatory inspections.