Quality Control Analyst – Microbiology

About the role

Novartis is seeking a Quality Control Analyst specialized in Microbiology to execute and document microbiological testing in compliance with GMP standards and SOPs. The role supports product release, stability studies, and technology transfer activities within a regulated laboratory environment.

Key responsibilities

• Perform microbiological analysis on excipients, drug substances, drug products, water and primary packaging according to internal SOPs.
• Execute stability, process validation and method validation protocols, including sterility testing for products from the AAA site.
• Carry out instrument performance qualification tests as required and ensure proper registration of results following ALCOA+ principles.
• Collaborate with management to achieve departmental objectives and maintain laboratory, instrument and work‑environment conditions.
• Coordinate microbiology laboratory activities and keep QC SOPs up to date.

Required profile

• Biological or Chemical degree (desirable).
• Minimum 2 years of experience in Microbiology QC within pharmaceutical companies; experience in radiopharmaceuticals is a plus.
• Fluent Italian and good knowledge of English.

Required skills

• Microbiological testing and sterility assessment.
• Good Manufacturing Practices (GMP) and ALCOA+ data integrity.
• Stability study execution, process and method validation.
• Instrument performance qualification.
• Quality Assurance, Quality Control, Quality Management Systems (QMS) and Statistical Process Control (SPC).