What are the responsibilities and job description for the Project Microbiologist position at Eagle Analytical?
Position Summary
The Project Microbiologist duties and functions include technical and management abilities to perform duties as experts in all aspects of microbiology.
Essential Responsibilities
- Perform routine testing on samples in a timely manner with no supervision; record results, track and meet assigned testing deadlines
- Perform maintenance, calibration and troubleshooting of assigned equipment and systems in order to meet testing deadlines; ensure all equipment and systems are operating within established calibration guidelines; notify manager promptly of calibration failures and repair needs
- Manage isolation and maintenance of cultures of bacteria or other microorganisms in prescribed or developed media, controlling moisture, aeration, temperature, and nutrition
- Examine characteristics to identify and classify microorganisms
- Maintain expertise for a variety of specialized microbiology laboratory equipment
- Direct optimization procedures for microbial growth, stabilization and product formulations
- Implement strict documentation standards for all work performed in the laboratory
- Plan and organize the laboratory’s day to day operations, including roles and responsibilities of micro staff
- Communicate technical and scientific information effectively to staff, management, and customers
- Enforce, train, supervise safe training and protocols for micro staff
- Maintain the highest standards for technical excellence and ethical behavior in all aspects of work and personnel interaction
- Prepare technical reports and recommendations based upon research outcomes
- Comply with Company policies, cGMPs, ISO 17025, and all applicable SOPs
- Assist with laboratory compliance audits and laboratory safety audits
- Support validation activities
- Accurately identify, monitor, and repot microbiological trends
- Provide technical review of adverse trends, action limit reports, and discrepancies
- Generate specifications for relevant inventory
- Order and maintain inventory
- Attend tradeshows and provide sales training
- Performs all other duties as Microbiologist II
- Write, revise and review SOPs in a timely manner, as required
- Assist with special projects, as assigned
- Performs all other duties, as required
Qualifications
- Bachelor’s degree in Microbiology or related science field, including at least 12 semester hours of hands on laboratory courses in microbiology and/or chemistry. Master’s degree preferred
- Five years of pharmaceutical/biochemical QC laboratory experience in a microbiology setting
- Ability to understand and comply with Company policies and SOPs, including safety rules and regulations
- Demonstrated experience in a microbiology laboratory (Q.C., pharmaceutical, biotech or clinical lab experience preferred), where one or more of the following functions was successfully performed: sterility testing, endotoxin testing, antibiotic assays, environmental monitoring, microbial identification and/or microbial limit testing (MLT)
- Excellent analytical, decision making and interpersonal skills
- Excellent verbal and written communication skills
- Working knowledge and understanding of microbiology principles and methods and the ability to communicate this information to others
- Ability to solve routine and non-routine laboratory issues
- Physical dexterity to accurately and precisely perform testing
- Intermediate level computer skills in Microsoft Office, Word, Excel, PowerPoint, Outlook and the Internet
Certifications:
Certified pharmacy technician, a plus
