A microbiologist is responsible for supporting plant-wide remediation activities and continuous improvement efforts with a focus on method development and validation. Plan and execute projects aimed at improving the compliance profile as well as function as Subject Matter Expert, contributing to audit-readiness. Perform routine testing and per review as needed.
- Adhere to SOPs and regulatory requirements such as GMPs, GDPs, GLPs and OSHA regulations.
- Perform microbiological testing and method validation related for the following microbiological test methods:
- Sterility Testing per USP
- Antimicrobial Effectiveness Testing (AET) per USP < 51>
- Endotoxin per USP
- Particulate Matter per USP ,
- Water for Pharmaceutical Purpose
- Microbiological growth promotion
- Experience with Disinfectant Efficacy Testing a plus
- Adhere to controlled substance requirements
- Receive, and release media, buffers, and microorganism cultures
- Update and review microbiological trending
- Compose, update, and review procedures and training materials
- Review / record daily temperature readings
- Sanitize the laboratory incubators and refrigerators
- Review media, material, and supply inventories
- Maintain and coordinate equipment / instrumentation maintenance, calibration, and repair work
- Clean and sanitize the microbiology laboratory rooms surfaces and equipment
- Manage personal time off by requesting the time off in company time keeping system for either PTO or VPTO according to company policy for salary employees. See company handbook for policy details.
- Bachelor’s degree in microbiology, biology, or related scientific field or equivalent experience
- Two (2) to Four (4) years of experience in a pharmaceutical microbiology laboratory*
- Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirements* *
- Experience performing microbiological testing / environmental monitoring using aseptic techniques* *
- Excellent interpersonal communication and organizational skills* *
- Qualified to work with controlled substances* *
- Knowledge and experience performing serial dilutions* *
- Experience Handling Biohazardous materials*
- Ability to interpret technical documents
- Proficiency in technical writing with an emphasis of deviations, CAPAs, etc.
- Project Management experience a plus
- Must be comfortable interacting within multiple areas of an organization and be able to communicate technical content in a concise and clear manner
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.