Microbiology QC Analyst - Biosimilar

Job Scope:
The Microbiology QC Analyst is responsible for performing microbiological analyses of raw materials, in-process products, and finished products to ensure compliance with GMP requirements, product safety, and the quality of biosimilar products. The role supports laboratory operations by ensuring accurate testing, proper documentation, environmental monitoring, and adherence to biosafety and data integrity standards.

Job Requirements:
Education: Bachelor’s degree to Master’s degree (Bac +3 to Bac +5) in: Microbiology, Biotechnology, Pharmaceutical Sciences, Laboratory Sciences

Experience: 1to 3 years of experience in pharmaceutical microbiology
• Knowledge of GMP / GxP environments
• Experience in biotechnology or biosimilar production is considered a plus

Professional Knowledge:
• Knowledge of pharmaceutical microbiology techniques (culture, identification, sterility testing, endotoxin testing)
• Good understanding of Good Laboratory Practices (GLP) and GMP requirements
• Experience in handling microbiological equipment (autoclaves, incubators, laminar flow hoods, microscopes)
• Knowledge of laboratory documentation and data traceability practices

Main Competencies:
• High level of rigor and attention to detail
• Strict adherence to procedures and quality standards
• Ability to work effectively within a team and under supervision
• Good organizational and analytical skills
• Strong sense of responsibility and compliance mindset

Duties and Responsibilities:
• Perform microbiological control tests according to SOPs and validated methods.

• Review and verify analytical results against established specifications.
• Ensure strict application of GMP and biosafety requirements.
• Document all analyses, observations, and test results in laboratory records and reports.
• Ensure data integrity and traceability in compliance with ALCOA+ principles.
• Prepare, clean, and maintain microbiological laboratory equipment and instruments.
• Perform environmental monitoring activities (air, surfaces, purified water testing).
• Participate in the qualification and maintenance of microbiological instruments.
• Identify and report Out of Specification (OOS) and Out of Trend (OOT) results.
• Support investigations and CAPA implementation under the supervision of the QC Supervisor.
• Collaborate with QA and Production teams to resolve non-conformities.
• Participate in microbiological method transfer and validation activities.
• Contribute to laboratory process optimization and continuous improvement initiatives.
• Support internal audits and regulatory inspections.