Microbiologist - Laboratory Testing
BioSpace
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.
Perform 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.
Record, report, and investigate unexpected test results with some supervision.
Prepare samples, reagents, and media for daily testing activities.
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. Comply with company policies and all applicable SOPs; adhere to ISO 17025, BSL‑t‑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.
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.
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.
With 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.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 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.
Intermediate level computer skills in Microsoft Office, Word, Excel, Outlook, and PowerPoint.
Ability to solve routine and non‑routine laboratory issues/problems.
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. Customer Service: Inspired to perform without outside help
Inspired to perform well by the ability to contribute to the success of a project or the organization
Inspired to perform well when granted the ability to set your own schedule and goals
Bachelors or better in Microbiology or related field.
SOP creation and implementation
Pharmaceutical/Bio‑Chemical QC Laboratory experience Preferred
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