On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a
Analyst – QC Microbiology
Vos tâches
Position Summary
The Analyst – QC Microbiology is part of the Microbiology team of the Quality Control department at BMS Boudry Site.
The main responsibilities of the position include performing and reviewing microbiological tests on raw materials, manufactured drug products and stability samples, performing Environmental Monitoring in cleanrooms, waters, and compressed gases, 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 – Microbiology activities 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).
Duties/Responsibilities
Microbiological testing of raw materials and drug products according to incoming testing, release, and stability specifications, and of manufacturing monitoring sampling and testing.
- Microbiological testing of raw materials and drug products according to incoming testing, release, and stability specifications.
- Microbiological validation activities: execution of validation
- Environmental monitoring of cleanrooms (microbiological and particles tests), compressed air, and waters (microbiological tests, TOC, conductivity, nitrates)
- Review of analytical raw data generated in the Microbiology Laboratory.
- Release of culture Media (growth promotion testing) and material used in Microbiology laboratory.
- Identifications of microorganisms.
Support QC Microbiology activities.
- Support to maintenance/calibration of equipment and keeps relationship with suppliers.
- P1 Training of other members of Quality Control or other departments
- General laboratory tasks (sample management, waste disposal management, cleanings, etc.).
- Supply management of consumables, including purchase requisitions.
- Creation and update of procedures, work instructions and other QC documents.
- Print Worksheets as required, for the purpose of the assignment by Manager or delegate
- Participation in projects and implementation of continuous improvement actions in the laboratory.
- Participation and presentations at 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.
Votre profil
Qualifications
Specific Knowledge, Skills, Abilities:
- Good knowledge on experience of environmental, water and gas 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 for extended periods of time and collaboratively within a team.
- Good 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.
- Advanced 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).
- Good knowledge of the LEAN and 5S concepts and methodologies.
- Flexible, able to adapt to change.
Education/Experience/ Licenses/Certifications:
- 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.
Date d'entrée
À convenir