Microbiologist I - Sterile

Position Summary 

The Microbiologist I duties and functions includes serving as a bridge between entry-level and advanced microbiology roles, offering a unique opportunity for candidates to further develop their skills in microbiology within the pharmaceutical and biotech industries. The Microbiologist I will assist in various laboratory testing procedures, manage samples, and contribute to quality control efforts while closely collaborating with senior microbiologists. 

Essential Responsibilities 

• Operate independently while maintaining a high level of responsibility for assigned tasks, conducting routine testing on samples—including sterility and endotoxin testing—in a timely manner to ensure compliance with regulatory standards.  
• Perform routine environmental monitoring of clean rooms, including the reading and interpretation of environmental monitoring (EM) plates. 
• Check method suitability for sterility tests and assist in troubleshooting any issues related to laboratory procedures.  
• Maintain the proper chain of custody for all samples, effectively managing aliquoting,    storage, receipt, and shipping processes.
• Participate in clean lab operations, preventive actions, and continuous improvement programs to reduce operating costs and enhance efficiency.  
• Enter and verify data in compliance with current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP), ensuring data integrity and accuracy.  
• Maintain various logbooks and documentation in accordance with Standard Operating Procedures (SOPs).  
• 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  

• Bachelor’s degree in Biology, Microbiology, or a related field, or equivalent relevant  experience.
• Preferred experience in sterility testing and clean room operations.  
• Strong understanding of microbiological techniques and laboratory protocols, with a solid grasp of microbiology principles and methods.Ability to effectively communicate this information.  
• Excellent attention to detail and strong organizational skills.
• Ability to work collaboratively in a team environment, following instructions accurately.   
• Strong teamwork skills, with effective verbal and written communication abilities across disciplines.
• Physical dexterity to perform testing accurately and precisely, along with the capability to work independently with minimal supervision.  
• Proficient in reading, understanding, and complying with company policies and SOPs,  including safety rules and regulations. 
• Intermediate proficiency 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:

• Proficiency in laboratory data entry and management systems.
• Experience in cGLP or cGMP regulated laboratories is a plus.

Certifications:

• N/A