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Analyst, QC Microbiology

Bristol-Myers Squibb Products SA
Date de publication


Position Summary

The QC Microbiology Analyst is part of the Microbiology team of the Quality Control department.
The main responsibilities of the position include performing Environmental Monitoring in cleanrooms, waters, and compressed gases for routine monitoring and area qualification.
The analyst will also perform and review microbiological tests on raw materials, manufactured drug products and stability samples and performing peer review of raw data.
The analyst may also participate in projects related to laboratory safety or continuous improvement and participates to QC documentation changes.
The QC Analyst carries out her/his activities in compliance, always, with laboratory procedures and safety rules (EHS) as well as good documentation and good manufacturing practices (GDP and GMP).
The position will report to Sr. Manager QC Microbiology.

Key Responsibilities

Microbiological testing of raw materials and drug products according to incoming testing, release, and stability specifications.
• Environmental monitoring of cleanrooms (microbiological and particles tests), compressed air, and waters (microbiological tests, TOC, conductivity, nitrates)
• Microbiological testing of raw materials and drug products according to incoming testing, release, and stability specifications.
• Support execution of method validation protocols
• Execute Peer Review of analytical raw data generated in the Microbiology Laboratory.
• Support release of culture Media (growth promotion testing) and material used in Microbiology laboratory.
• Preparation of microorganism’s identifications.

Support QC Microbiology activities.
• Support maintenance/calibration of equipment and keeps relationship with suppliers.
• Support training of other members of Quality Control or other departments
• Perform general laboratory tasks (sample management, waste disposal management, cleanings, etc.).
• Support supply management of consumables, including purchase requisitions.
• Create and update of procedures, work instructions and other QC documents.
• Participation in projects and implementation of continuous improvement actions in the laboratory.
• Participate and create presentations at QC team meetings.
• Respect 5S principles and propose 5S improvements.
• Other responsibility assigned by the laboratory management.

Promotes safe practices and behaviors.
• Report immediately incidents to Environmental Health and Safety department, participate in investigations and identify measures to prevent similar accidents in the future.
• Demonstrate Bristol Myers Squibb values.

Qualifications & Experience

Education and Experience
• Federal Certificate of Capacity as Laboratory Technician or similar education.
• At least 1 year of work experience in a GMP environment or regulated industry.
• Experience with microbiological testing according to compendial harmonized methods.
• Good knowledge and ability to apply GDP and GMP rules.

Required Competencies: Knowledge, Skills, and Abilities
• Knowledge on experience of environmental and water and compressed air monitoring.
• Knowledge of good microbiological practices and contamination control concepts.
• Knowledge of regulatory requirements related to microbiological testing and environmental monitoring.
• Good organizational skills and good multi-tasking ability; ability to set and focus on priorities.
• Strong attention to details
• Ability to work independently and collaboratively within a team.
• Knowledge of laboratory safety rules.
• Ability to write business and technical documents (good technical writing skills).
• Capable of independent problem-solving; informs management as appropriate.
• Computer proficiency (Windows and MS Office) and ability to use a LIMS.
• Fluency in French and professional command of English (oral and written)
• Ability to communicate effectively with peers (QC members, management, other departments).
• Knowledge of the LEAN and 5S concepts and methodologies.
• Flexible, able to adapt to change.
• Able to stand for several hours, lift boxes about 24 kg or reach areas of 2 meters.

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