Microbiology QC Analyst – Biosimilar

About the role

The Microbiology QC Analyst will perform microbiological testing of raw materials, in‑process and finished biosimilar products to ensure compliance with GMP, product safety and quality. The role supports the laboratory by delivering accurate results, maintaining equipment and following strict biosafety and data integrity standards.

Key responsibilities

• Perform microbiological control tests according to SOPs and validated methods.
• Review and verify analytical results against specifications.
• Document all analyses, observations and test results in laboratory records.
• Maintain data integrity and traceability following ALCOA+ principles.
• Prepare, clean and maintain microbiological equipment (autoclaves, incubators, laminar flow hoods, microscopes).
• Conduct environmental monitoring (air, surfaces, purified water).
• Identify and report Out‑of‑Specification (OOS) and Out‑of‑Trend (OOT) results.
• Support investigations, CAPA implementation and internal audits under supervision.
• Collaborate with QA and Production to resolve non‑conformities.
• Participate in method transfer, validation and continuous improvement initiatives.

Required profile

• Bachelor’s or Master’s degree in Microbiology, Biotechnology, Pharmaceutical Sciences or related field.
• 1‑3 years of experience in pharmaceutical microbiology, preferably in a GMP/GxP environment.
• Strong attention to detail, rigor and adherence to procedures.
• Ability to work effectively in a team and under supervision.

Required skills

• Microbiological culture, identification, sterility and endotoxin testing.
• Knowledge of GMP, GxP and GLP requirements.
• Operation of autoclaves, incubators, laminar flow hoods and microscopes.
• Laboratory documentation and data traceability (ALCOA+).
• Environmental monitoring techniques.