Microbiologist II - Sterile

Position Summary

The Microbiologist duties and functions include the ensuring the sterility and quality of pharmaceutical and biotech products. You will be responsible for performing sterility and particulate testing, managing samples, supporting special projects, and contributing to the continuous improvement of laboratory operations.

Essential Responsibilities

• 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, ensuring compliance with regulatory standards.
• Review schedules and develop plans to guarantee that all required samples are collected and tested on time. Reconcile test samples at the end of the incubation period to confirm proper handling and processing within required limits.
• 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. Ensure that SOPs are accurate, up-to-date, and aligned with all required regulatory documents.
• 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, while maintaining familiarity with all applicable equipment and systems.
• 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.

Qualifications

• 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.
• Preferred 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.

Preferred Qualifications and Skills:

• Master’s degree with 2 years of relevant experience.
• Experience in cGLP or cGMP regulated laboratories is a plus.

Certifications:

• N/A