The Microbiologist duties and functions include the testing and quality assurance of materials and/or products.
What You Will Do
• Perform routine testing on samples in a timely manner with minimal supervision; record results, track and meet assigned testing deadlines.• Record, report and investigate unexpected test results. • 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.• Complies with company policies and all applicable SOPs; complies with ISO 17025, cGMPs, cGLPs A2LA requirements and Quality Control Guidelines.• Ensure compliance with all Standard Operating Procedures (SOPs), ensure that SOPs are accurate, up-to-date, and parallel to all required regulatory documents.• Participate in cross technology educational program within the laboratory to learn all laboratory functions.• Maintain familiarity with use of all applicable equipment, systems, and procedures (SOPs)• Stay abreast of current technology and instruments, with emphasis on microorganisms, equipment and system troubleshooting, and microbiology/taxonomy issues.• Provide technical assistance and back-up support in all laboratory workstations as required.• Maintain current and accurate documentation.• Write, revise and review SOPs in a timely manner as required.• Comply with Company policies and all applicable SOPs.• Assist with laboratory compliance audits and laboratory safety audits.• Maintain clean, orderly, and safe laboratory work area; assist with safety training.• Perform more complex testing on samples (i.e., Elisa, USP 61/62, etc.)• Support validation activities• Accurately identify, monitor, and report microbiological trends.• Provide technical review of adverse trends, action limit reports, and discrepancies.• Train new/old microbiology staff• Orders supplies and keeps accurate records of microbiology inventory.• Assist customers with reviews of testing results, etc.• Assist with special projects as assigned.• Performs all other duties as required.• Provide training to customers and develop training materials.• Perform all other duties as Microbiologist II.
Who You Are
• Master’s degree in microbiology or bachelor’s degree in microbiology including at least 12 semester hours of hands-on laboratory courses in microbiology and/or chemistry.• Minimum 2 years’ experience of pharmaceutical/biochemical QC laboratory experience in a microbiology setting with bachelor’s degree.• Demonstrated relevant 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/problems.• Physical dexterity to perform testing accurately and precisely.• Ability to read, understand and comply with Company policies and SOPs, including safety rules and regulations.• Intermediate level computer skills in Microsoft Office, Word, Excel, Outlook and PowerPoint
