Biotech Microbiologist Specialist
2 weeks ago
Microbiologist II
Job Summary:The Microbiologist II is responsible for ensuring the sterility and quality of pharmaceutical and biotech products.
Key Responsibilities:- Perform sterility and particulate testing, managing samples, supporting special projects, and contributing to the continuous improvement of laboratory operations.
- Operate independently while maintaining a high level of responsibility for assigned tasks, conducting routine testing on samples-including Sterility, Endotoxin, and Particulate Matter testing-in a timely manner and with minimal supervision.
- Ensure compliance with regulatory standards, reviewing schedules and developing plans to guarantee that all required samples are collected and tested on time.
- Maintain the proper chain of custody for all samples, managing aliquoting, storage, receipt, and shipping effectively.
- Participate in clean lab operations, preventive actions, and continuous improvement programs to reduce operating costs and enhance efficiency.
- Perform maintenance, calibration, and troubleshooting of assigned equipment and systems to meet testing deadlines.
- Promptly troubleshoot and resolve technical issues related to laboratory procedures and cleanroom operations, notifying management of any calibration failures or repair needs.
- Adhere to company policies and applicable Standard Operating Procedures (SOPs), including ISO 17025, cGMP, cGLP, A2LA requirements, and Quality Control Guidelines.
- Calculate, evaluate, and review data, ensuring clear communication of results both verbally and in written format.
- Draft and review SOPs to ensure consistent execution of laboratory processes.
- Stay current with technology and instruments, particularly in the areas of microorganisms, equipment troubleshooting, and microbiology/taxonomy issues.
- Participate in a cross-technology educational program within the laboratory to gain a comprehensive understanding of all functions.
- Assist with special projects for pharmaceutical and biotech clients, contributing expertise and innovative solutions.
- Support the training and onboarding of new team members to ensure their competency and compliance with laboratory procedures.
- Communicate effectively across departments, including Quality Assurance, Client Care, and other internal teams, to ensure smooth workflow and alignment with company objectives.
- Master's degree in Biology, Microbiology, or a related field, or a Bachelor's degree with 3+ years of relevant experience in microbiology or a laboratory setting.
- Prefered experience working with Biological Safety Cabinets (BSC) and in clean room environments.
- Demonstrated relevant experience in a microbiology laboratory (Q.C., pharmaceutical, biotech, or clinical lab preferred), with expertise in one or more of the following functions: sterility testing, endotoxin testing, antibiotic assays, environmental monitoring, microbial identification, and/or microbial limit testing (MLT).
- Strong understanding of microbiology principles and methods, with the ability to communicate this information effectively.
- Excellent analytical, decision-making, and interpersonal skills, with a high degree of accountability, attention to detail, and integrity in all tasks.
- Strong teamwork and collaboration skills, with excellent verbal and written communication abilities across disciplines.
- Physical dexterity to perform testing accurately and precisely, along with the ability to work independently with minimal supervision.
- Proficient in reading, understanding, and complying with company policies and SOPs, including safety rules and regulations.
- Intermediate computer skills in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
- Ability to maintain focus and complete work in a timely manner, with a willingness to adapt and learn new skills as needed.
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