Microbiologist I - Non-Sterile

Position Summary

The Microbiologist I performs routine microbiological testing to support product quality and safety, ensuring compliance with USP, cGMP and ISO 17025 standard, accurate documentation, data integrity and basic lab support in a regulated environment.

What You Will Do

• 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.
• Prepare and assist with special projects, as needed.
• Manufacturing and quality control testing for in-house media production.
• Aseptic production of BSL-1 and BSL-2 microbial stocks.

Who You Are

• 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
• 0 to 2 years of pharmaceutical/biochemical QC laboratory experience
• 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, other applicable testing/skills.
• Ability to multitask within a single task and multiple tasks when applicable.
• Excellent analytical, decision making and interpersonal skills
• Ability to work independently, with some supervision
• 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 laboratory issues/problems
• Physical dexterity to accurately and precisely perform testing
• Can work within a team to achieve the same goal
• Ability to read, understand and comply with Company policies and SOPs, including safety rules and regulations
• Entry level computer skills in Microsoft Office, Word, Excel, Outlook and PowerPoint
• Ability to stay on task to complete work in a timely manner
• The ability to adapt and learn new skills as needed

Who We Are

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. (http://www.eagleanalytical.com)

Experience

• Virology and Fibology
• SOP creation and implementation
• 3 year(s): Pharmaceutical/Bio-Chemical QC Laboratory experience

• 2 year(s): GMP and or cGMP

Education

• Bachelors or better in Microbiology or related field

Skills

• Customer Service
• Communication
• Active Listening

Behaviors

• 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

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

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.