Microbiologist II - Non-Sterile

About the role

The Microbiologist II performs routine microbiological testing to ensure product safety and regulatory compliance. This role includes quality control and quality assurance of materials and products, requiring an advanced understanding of USP, cGMP, ISO 17025, and other applicable regulatory requirements.

Responsibilities

• Perform and result routine microbiological testing on samples in a timely manner, independently with some supervision, to meet assigned testing deadlines.
• Ensure accuracy and validity of results in accordance with SOPs and regulatory standards.
• Interpret test results to determine pass/fail status and escalate unexpected findings to senior staff.
• Record, report, and investigate unexpected test results with some supervision.
• Prepare samples, reagents, and media for daily testing activities.
• Support sample receipt and chain of custody documentation.
• Regularly handle BSL-1 and BSL-2 regulated microorganisms following proper safety and workflow practices.
• Maintain current and accurate documentation in compliance with GMP and GDP standards.
• Clean, organize, and maintain laboratory workspaces and equipment to ensure readiness and compliance.
• Perform standard operational maintenance and minimal troubleshooting of assigned equipment and systems to confirm equipment is operational prior to use. Notify supervisor and engineering promptly of calibration failures and repair needs.
• Ensure proper disposal of biohazard waste in accordance with SOPs.
• Comply with company policies and all applicable SOPs; adhere to ISO 17025, BSLT-2 cGMPs, cGLPs, A2LA requirements, and Quality Control Guidelines.
• Participate in training sessions and cross-technology educational programs to expand technical knowledge and proficiency in advanced microbiological techniques.
• Stay abreast of current technology and instruments, with emphasis on microorganisms, equipment troubleshooting, and microbiology/taxonomy issues.
• Provide technical assistance and back-up support across laboratory workstations as required.
• Overtime and occasional weekend hours may be required.
• Assist with laboratory compliance audits and laboratory safety audits.
• Perform more complex testing on samples (method suitability modifications, method development, etc.).
• Support supervisor or project microbiologists in validation activities as assigned.
• Accurately identify, monitor, and report microbiological trends.
• Assist in revising and reviewing compliance with all Standard Operating Procedures (SOPs), ensuring SOPs are accurate, up-to-date, and parallel to all required regulatory documents.
• Maintain familiarity with use of all applicable equipment, systems, and procedures (SOPs).
• Manufacturing and quality control testing for in-house media production.
• Aseptic production and quality control of BSL-1 and BSL-2 microbial stocks.
• Lead the microbiology staff in the execution of special projects, as needed.
• Train and mentor microbiology staff.

Requirements

• 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.
• 3-5 years of pharmaceutical/biochemical QC laboratory experience in microbiology, or master’s degree in microbiology or related science field with 2-3 years of pharmaceutical/biochemical QC laboratory experience in a microbiology lab.
• 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: microbial enumeration testing, growth promotion testing, streak for isolation, testing with microorganisms, environmental monitoring, method suitability, microbial identification, gram staining, pipetting small volumes, SOP/documentation revisions, or other applicable testing/skills.
• Excellent analytical, decision-making, and interpersonal skills.
• Excellent verbal and written communication skills.
• Excellent working knowledge and understanding of microbiology principles and methods and the ability to communicate this information to others.
• Physical dexterity to perform testing accurately and precisely.
• Ability to read, understand, and comply with company policies and SOPs, including safety rules and regulations.
• Ability to work independently, with minimal supervision.
• Intermediate-level computer skills in Microsoft Office, Word, Excel, Outlook, and PowerPoint.
• Ability to adapt, learn, and teach new skills as needed.
• Ability to work within a team to achieve the same goal.
• Ability to multitask within a single task and multiple tasks when applicable.
• Ability to solve routine and non-routine laboratory issues/problems.

About the company

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination, and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing but also working relentlessly with our customers on solutions if tests receive unexpected results.

Learn more at www.eagleanalytical.com.

Skills

• Customer Service (Advanced)
• Communication (Novice)
• Active Listening (Novice)
• Team Player: Works well as a member of a group
• Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

Behaviors & Motivations

• Self-Starter: Inspired to perform without outside help
• Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization
• Flexibility: Inspired to perform well when granted the ability to set your own schedule and goals

Experience & Education

• Preferred: Bachelor’s or better in Microbiology or related field.
• Required: 3 years of virology and fibology SOP creation and implementation experience in a pharmaceutical/biochemical QC laboratory.
• Preferred: 2 years of GMP and/or cGMP experience.