Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting
Job Description
Job Summary
Thermo Fisher Scientific Inc. is seeking an exceptionally skilled QC Scientist III to join our Quality Control team. The QC III Microbiology role is pivotal in ensuring the safety, quality, and compliance of our products through flawless microbiological testing and analysis. This is a remarkable opportunity to contribute to a world-class organization dedicated to making the world healthier, cleaner, and safer.
Key Responsibilities
- Microbiological Testing: Perform routine and non-routine microbiological tests, including sterility testing, bioburden, endotoxin testing (LAL), microbial limits testing, water testing, and environmental monitoring.
- Method Validation & Optimization: Assist in the development, validation, and optimization of microbiological methods to meet regulatory standards.
- Quality Control Procedures: Strictly adhere to GLP, GMP, FDA, EMA, and ISO regulations to maintain product integrity and compliance.
- Data Analysis & Documentation: Review and interpret test results, ensuring accurate documentation and reporting. Generate comprehensive reports, deviations, and investigations.
- Equipment Calibration and Maintenance: Ensure all microbiological testing equipment is calibrated and efficient in working condition.
- Training and Mentorship: Offer training and mentorship to junior team members, encouraging an environment of continuous learning and development.
- Cross-functional Collaboration: Work collaboratively with R&D, Manufacturing, and Regulatory Affairs to ensure smooth coordination during product testing, investigations, and audits.
- Root Cause Analysis: Lead or assist in investigating microbiological failures, conducting root cause analysis, and implementing corrective actions.
- Alignment with Regulatory Standards: Participate in internal and external audits, ensuring all activities align with regulatory standards.
- Inventory & Reagents: Maintain inventory of microbiological testing supplies, accurately stock and store reagents and consumables.
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Qualifications
- Education:
Bachelor's degree in Microbiology, Biology, Biotechnology, or a related field or equivalent experience is required.
- Experience:
Minimum of 3-5 years of experience in microbiological testing within a regulated industry.
1. Proven experience with microbiological testing methods such as Bioburden testing, endotoxin testing, microbial limits testing, and environmental monitoring.
- Technical Skills:
Strong understanding of microbiological laboratory techniques and equipment.
1. Familiarity with regulatory requirements (FDA, EMA, ISO) and quality control systems.
Experience with LIMS and other data management tools.
- Soft Skills:
Strong attention to detail and analytical thinking.
1. Excellent communication skills, both written and verbal.
Ability to work independently and as part of a team.
1. Strong organizational and time-management skills.
- Physical Requirements:
Ability to work in a laboratory environment, including standing for extended periods and handling chemicals.
1. Occasional lifting of laboratory equipment or supplies (up to 25 lbs).
- Work Conditions:
Standard laboratory environment.
1. Availability for overtime or on-call duties may be required.
- Join us at Thermo Fisher Scientific Inc. and become a part of an ambitious team dedicated to excellence and innovation in microbiological quality control.