What Does A Microbiologist Do?

WHAT DOES A MICROBIOLOGIST DO?

Published: Dec 03, 2025 - The Microbiologist performs molecular and serological testing, evaluates diagnostic methods, and ensures accurate results through rigorous quality assurance and quality control procedures. This role involves managing specimen workflows using a laboratory information management system, providing technical guidance and training, and supporting public health partners through timely reporting and consultation. The individual also participates in proficiency testing, adheres to safety standards, and contributes to continuous learning to maintain strong technical expertise.

A Review of Professional Skills and Functions for Microbiologist

1. Microbiologist Duties

Laboratory Experiments: Perform laboratory experiments used to diagnose and treat illnesses.
Team Supervision: Supervise biological technicians and their work to evaluate the accuracy of their results.
Culture Isolation: Isolate bacteria and other microorganism cultures for future study.
Microorganism Classification: Classify microorganisms found in collected specimens for future reference.
Effects Monitoring: Monitor the effects of microorganisms on animals, plants, and the environment.
Scientific Research: Research the findings of other scientists and attend conferences to stay up-to-date.
Report Publishing: Publish research papers and technical reports of findings.
Findings Presentation: Present findings to other scientists, engineers, executives, and the public.

2. Microbiologist Details

Test Administration: Administer and conduct tests or examinations and evaluate results.
Item Analysis: Analyze and test items, interpret results, and implement changes.
Policy Interpretation: Interpret, clarify, explain, and apply agency policy and procedures, business practices, and federal or state laws and regulations.
Data Maintenance: Maintain technical data, generate reports and findings, and defend analytical work during hearings or litigation.
Data Review: Review data, records, and files for detail and accuracy.
Technical Assistance: Provide technical assistance on agency issues, services, programs, computer hardware, and software.
Regulatory Compliance: Ensure compliance with applicable federal and state laws, regulations, agency rules, standards, and guidelines.
Record Keeping: Maintain accurate records and logs.
Specimen Preparation: Prepare specimens for laboratory analysis by preparing media, solutions, and reagents, and perform stains, slide preparation, smears, animal dissections, or other technical laboratory procedures.
Rule Development: Develop or modify rules, policies, or standards.
Compliance Reporting: Write reports for compliance with dairies.
Dairy Auditing: Audit dairies in the State of Utah.
Pathogen Handling: Work with foodborne pathogens.

3. Microbiologist Responsibilities

Microbiological Testing: Ensure facilities, processes, personnel, and materials or products are microbiologically tested in line with cGMP and procedural requirements.
Operational Support: Provide microbiological support for Operations.
SAP Utilisation: Utilise the SAP business system to facilitate product release.
OOS Management: Manage out-of-specification results, facilitate laboratory investigation reports, and involve the laboratory manager.
Data Trending: Collect and trend data, react to trends, and report findings to the laboratory manager.
Metric Maintenance: Maintain laboratory metrics.
Sterilisation Validation: Remain responsible for the sterilisation validation programme to maintain compliance with ISO 11137, ISO 11135, and ISO 17765.
Regulatory Compliance: Ensure compliance is maintained as directed by Notified Bodies regulations.
GMP Adherence: Comply with GMP requirements and uphold these standards.
Environmental Monitoring: Perform environmental monitoring and routine product monitoring, including bioburden and VDmax25, while complying with EHS requirements and upholding these standards.
Continuous Improvement: Seek and deliver continuous improvement opportunities across the site.
Method Validation: Perform method validations.

4. Microbiologist Job Summary

Project Collaboration: Work as an integral part of the pre-commercial team to achieve project goals.
Microbial Purity: Assess microbial purity from the cell bank through all bio-processing steps.
Method Development: Develop standard enumeration methods and protocols for R&D.
Viability Assays: Ensure viability assay development and optimization for strains and product concepts.
Morphology Tracking: Identify and track microbial morphology in processes and build models relating these characteristics to plant outcomes, fermentation conditions, and bacterial stability.
Media Experiments: Develop and conduct experiments on panels of media to determine optimal growth of selected strains.
Strain Screening: Develop and conduct assays for high-throughput screening of strains for robustness and fermentability.
SOP Development: Develop SOPs and train the team on proper microbiology procedures and lab hygiene.

5. Microbiologist Accountabilities

Method Development: Develop microbiological test methods and method validations.
Product Testing: Perform microbiological testing of raw materials, work-in-process, and finished products for product approval and release.
Employee Training: Train new employees in the microbiology laboratory.
GMP/GLP Documentation: Maintain GMP and GLP documentation relevant to assigned duties and responsibilities.
Instrument Maintenance: Maintain laboratory instrumentation required for testing.
Data Review: Assist in reviewing test data and report deviations to the supervisor.
Cross-Department Coordination: Interact and coordinate activities with other departments and external vendors to support and meet facility goals and objectives.
SOP Support: Assist management in writing and updating Standard Operating Procedures.
Project Participation: Participate in projects involving the Quality Control or Microbiology departments.
Team Training: Train team members in microbiology and chemistry laboratories.
Biohazard Handling: Ensure proper handling and disposal of biohazard material in compliance with OSHA and Standard Operating Procedures.

6. Microbiologist Functions

Laboratory Testing: Conduct laboratory testing according to corporate and regulatory guidelines, including study design, protocol development, and final report preparation.
Project Management: Conduct pre-project reviews and manage projects, including planning, staffing, and study implementation.
Client Interaction: Interact with clients, including providing sales support.
Study Oversight: Oversee study progress and ensure the generation of quality data.
Executive Communication: Communicate study progress and other relevant information to executive management.
Growth Tracking: Track microorganism growth and manage incubation, plating, and counting schedules.
Timeline Management: Meet project timelines and study budgets.
Work Environment: Promote an efficient and professional work environment.

7. Microbiologist Job Description

Media Preparation: Prepare media for microbiological testing, including growth promotion of all media prepared in-house or purchased.
Culture Maintenance: Prepare and maintain microbiological stock cultures or suspensions according to applicable test methods.
Water Testing: Perform USP purified water collection and testing.
Environmental Monitoring: Perform environmental monitoring in manufacturing, packaging, and laboratory areas through surface swabs and viable air sampling.
Microbial Limits Testing: Perform microbial limits testing on all finished products and specified raw materials.
Organism Identification: Identify organisms by isolating cultures, performing Gram stains, interpreting slides, conducting biochemical testing, and using selective media, identifying organisms to genus and species level.
Antibiotic Assays: Perform microbiological antibiotic assays.
AET Testing: Perform Antimicrobial Effectiveness Testing and method suitability.
GMP Documentation: Maintain good documentation in accordance with GMP, including timely recording of information.
Supply Notification: Notify appropriate microbiology personnel or management when supplies require ordering.
Personnel Training: Assist in training new personnel.
Lab Housekeeping: Participate in laboratory housekeeping, including cleaning of glassware.
Investigation Support: Perform related duties, including laboratory investigations, deviation investigations, CAPAs, change requests, and SOP revisions.

8. Microbiologist Overview

Material Testing: Perform microbiological testing to support material release, material clearance, and the environmental monitoring program in the plant.
cGMP Compliance: Perform all laboratory tasks and activities such as testing and documentation in accordance with cGMP and 21 CFR 820 requirements.
Team Collaboration: Collaborate with internal and cross-functional colleagues to ensure testing and releases are completed on time.
Project Assistance: Assist cross-functional teams on projects requiring microbiological testing and clearance.
Continuous Improvement: Support continuous improvement projects in the laboratory.
Procedure Adherence: Follow SOPs, test methods, and approved written procedures in the laboratory.
Testing Accuracy: Display accuracy and attention to detail when completing testing and documenting results with minimal errors, including review and verification sign-offs of colleagues’ notebooks, forms, and data.
Non-Routine Work: Work on non-routine projects as directed by Quality Control Laboratory management.
Cross-Training: Cross-train in different laboratories and activities across the Quality Control organization.
Investigation Support: Support the laboratory supervisor in excursion and Out-of-Specification investigations, compile data, and participate in the steps of the investigation process while interacting with other teams to assist with investigations and corrective actions.
Lab Housekeeping: Clean glassware, dispose of waste, inventory chemicals and supplies, and perform other housekeeping duties.
Data Trending: Collect and trend microbiological and environmental monitoring data for use in reports for management and internal groups.

9. Microbiologist Details and Accountabilities

Microbiological Testing: Conduct microbiological and other testing of systems, raw materials, in-process checks, finished products, components, and stability products using established test methods to provide accurate and reliable data to assure microbiological quality and compliance.
Data Assurance: Assure through review that the generated data is accurate, reliable, and reproducible.
Training Support: Train and assist laboratory associates in interpreting regulatory and compendial requirements.
Non-Routine Support: Support Senior Microbiologists and the Microbiology Quality Leader in performing non-routine activities according to established methods and procedures.
Instrumentation Troubleshooting: Troubleshoot instrumentation used in routine testing.
Error Correction: Correct erroneous data and train associates to prevent future errors.
Deviation Support: Support the resolution of manufacturing deviations.
Investigation Support: Support Senior Microbiologists and the Microbiology Quality Leader in investigations using analytical techniques to address manufacturing issues, product quality concerns, customer complaints, or human error.
Issue Escalation: Escalate difficulties encountered during routine testing and data review to laboratory supervision for discussion and approval before release.

10. Microbiologist Tasks

QC Testing: Perform Quality Control laboratory testing to ensure patient safety within a Good Manufacturing Practices (GMP)/Good Lab Practices (GLP) environment in support of active pharmaceutical ingredients, incoming and raw materials, in-process product, finished product, stability, and validation.
Data Interpretation: Interpret data output to determine conformance with product specifications and record results.
Safety Compliance: Understand, implement, and maintain a safe work environment for themselves and others in accordance with procedural requirements.
Microbiology Techniques: Have experience and command of multiple microbiological techniques, equipment, and instruments, such as aseptic technique.
Troubleshooting Skills: Independently troubleshoot and resolve microbiological techniques and instrument issues.
Training Maintenance: Maintain training and accept responsibility for acquiring knowledge and experience to support continual personal development.
Proactive Communication: Communicate proactively with supervisor and team members on a frequent basis to ensure timely product release.

11. Microbiologist Roles

Microbiological Analysis: Perform microbiological analysis.
Sample Testing: Test microbiological samples from all stages of the production processes of licensed and developmental products.
Result Assessment: Assess results against pre-set standards and specifications.
Data Recording: Record all information and data clearly and accurately.
Culture Maintenance: Maintain the Bacteriology Technical Services culture collection, media stocks, and consumables.
Safety Compliance: Comply with and work in accordance with PBL safety policies and procedures.
Regulatory Adherence: Adhere to legal, corporate, and site legislation.

12. Microbiologist Additional Details

Method Development: Develop and implement methods and systems for detecting and profiling microorganisms in manufacturing sites, ingredients, and products.
Microbial Control: Lead cross-functional initiatives to control microbial populations in facilities, ingredients, and products by optimizing environmental controls, formulations, processes, and surveillance methods.
Quality Investigation: Work with cross-functional teams to investigate potential impacts of microbes on product quality.
Shelf-Life Optimization: Identify and develop scalable solutions and technologies to optimize product shelf life.
Cross-Functional Collaboration: Collaborate and influence cross-functionally across R&D, QC, Product Commercialization, and Manufacturing teams.
Method Validation: Maintain validation of microbiology test methods.
Equipment Maintenance: Ensure maintenance of operational equipment within the laboratory and maintain equipment in a validated state.

13. Microbiologist Essential Functions

Microbiological Testing: Perform raw material, in-process, and finished goods microbiological testing according to compendial and non-compendial test methods while adhering to cGMP requirements for pharmaceutical products.
Environmental Monitoring: Sample, perform, monitor, and trend all environmental testing associated with the facility.
Pest Control Monitoring: Monitor and trend pest control activities at the facility.
GMP Documentation: Document according to cGMP requirements and review all testing on time to support the manufacturing facility.
OOS Investigations: Perform Out-of-Specification investigations and determine appropriate corrective and preventive actions.
Protocol Preparation: Prepare protocols, summaries, and reports related to sanitation testing, validation, routine monitoring, SOPs and IQ, OQ and PQ activities.
Equipment Maintenance: Perform validations, calibrations, and preventive maintenance on all equipment within the microbiology laboratory.
Issue Escalation: Escalate non-conformances and Out-of-Specification results promptly and in accordance with local and corporate procedures.

14. Microbiologist Role Purpose

Standard Testing: Perform laboratory tests according to prescribed standards and procedures.
Challenge Testing: Perform bacterial challenge tests.
Growth Testing: Perform microbial growth tests.
Endotoxin Testing: Perform endotoxin testing using L.A.L.
Sterility Testing: Perform sterility tests.
Water Analysis: Perform microbiological water analysis.
Spore Determination: Perform spore population determination.
Environmental Monitoring: Perform environmental monitoring for all clean rooms.
Particle Counting: Perform particle counts for non-viable particulates.
Media Preparation: Prepare culture media and maintain culture stocks.
Lab Cleaning: Clean glassware and equipment.
Record Keeping: Initiate and keep test results and records.
Supply Inventory: Maintain inventory of supplies needed to support tests.
Procedure Improvement: Submit or suggest changes to existing procedures.
GxP Compliance: Assure compliance with GMPs and GLPs.
Report Preparation: Prepare and issue reports.
Non-Conformance Investigation: Investigate non-conformances, take appropriate actions, and record events.

15. Site Quality Microbiologist General Responsibilities

Contamination Control: Establish and maintain the site’s microbiological and viral contamination prevention and control programs.
Quality Assurance: Ensure that the microbiological quality of products, manufacturing facilities, and utilities meets company, local, and global requirements.
Sterility Strategy: Develop and deploy strategies and measures designed to ensure a continuous state of contamination control and sterility assurance across the site.
Technical Leadership: Provide technical, scientific, and strategic leadership and support to cross-functional teams and business partners on all microbiological topics and microbial-based projects.
Competency Growth: Grow the site’s microbiology competence, capability, and capacity.
Regulation Tracking: Keep up to date with new regulations, trends, and best industry practices related to sterility assurance.
Global Collaboration: Collaborate and network with the global Microbiological Sterility Assurance organization.
Compliance Oversight: Provide on-site quality and compliance oversight of production activities to ensure standards are met, patient safety is safeguarded, and the company's reputation is protected.
Document Leadership: Author, review, and approve documents from processes and provide leadership and management to these processes.
Program Ownership: Own the site Microbial Control Strategy and Response Committee and remain accountable for sterility assurance, biocontamination control, aseptic competence, hygiene, and gowning.
Compliance Decisions: Make decisions on nonconforming processes and products, identify and resolve compliance risks, and help R&D and supply chain groups comply with applicable regulations.
Quality Tool Deployment: Lead the deployment of quality work tools such as event management, risk assessments, change controls, and CAPAs when addressing microbiology-related non-conformances.
SME Support: Author, review, and approve study plans, analytical methods, specifications, memos, and assessments as an SME, consultant, team member, or team leader.
Supplier Support: Support supplier audits and vendor qualification activities.

16. QC Microbiologist Key Accountabilities

Microbiological Testing: Conduct microbiological testing of DI water, raw materials, bulk, and finished products in compliance with appropriate Standard Operating Procedures and Laboratory Methods.
Environmental Testing: Carry out environmental testing in compliance with appropriate Standard Operating Procedures and Laboratory Methods.
Material Release: Release raw materials, bulks, and finished goods from quarantine after testing and in compliance with the appropriate Standard Operating Procedures and Laboratory Methods.
Method Validation: Participate in the validation of cleaning procedures and other methods.
Physical Testing: Conduct physical testing of bulk and finished products in compliance with appropriate Standard Operating Procedures and Laboratory Methods.
Sample Control: Ensure all samples tested are controlled and retained in accordance with appropriate Standard Operating Procedures.
Non-Conformance Handling: Raise non-conformances for any raw materials, bulks, and finished goods that do not meet specifications in accordance with SOP.
Standards Maintenance: Assist in the control and maintenance of all laboratory standards in accordance with the relevant SOP or customer regulatory requirements.
Database Management: Be responsible for the maintenance of databases relevant to all tests performed.
Issue Resolution: Assist in the resolution of technical and quality issues.
Equipment Operation: Operate requisite laboratory equipment and instruments, record data, and maintain and make minor adjustments to equipment.
Equipment Care: Prepare, clean, and maintain laboratory equipment, glassware, and instruments used in testing.
Failure Reporting: Report any equipment failures to the QC Laboratory Supervisor for resolution.
GxP Compliance: Maintain high standards of GLP and GMP at all times in the laboratory and other accountable areas.
Laboratory Support: Carry out any other reasonable duties at the request of the QC Laboratory Supervisor or the Quality Manager.

17. Microbiologist Roles and Details

Molecular Techniques: Perform molecular techniques using real-time polymerase chain reaction for qualitative detection of targeted pathogens and follow sequencing protocols for Illumina platforms to support variant identification.
Serological Testing: Perform serological testing to determine recent infections caused by various microorganisms in serum, including the novel coronavirus.
Sample Reception: Perform sample reception and conduct pre-analytical checks by reviewing submission forms and assessing specimen quality.
Quality Assurance: Perform quality assurance checks in the analytical phase using quality controls and internal controls, and complete post-analytical interpretation and troubleshooting to ensure accurate test outcomes.
Procedure Evaluation: Perform and evaluate new diagnostic procedures to determine their performance characteristics and suitability for laboratory use.
Method Evaluation: Evaluate the performance of updated procedures, methods, equipment, and reagents by reviewing principles, following protocols, completing validations, and analyzing results to support decisions that protect public health.
LIMS Management: Use a laboratory information management system to accession specimens, manage samples throughout testing workflows, and report laboratory results on time to laboratory and public health partners.
Proficiency Testing: Participate in proficiency testing to maintain high-quality standards for molecular detection, typing, and subtyping of viruses in compliance with regulatory requirements.
Quality Control: Perform quality control checks on equipment, reagents, controls, and procedures to ensure reliable testing that safeguards public health.
Quality Policies: Follow internal quality control and quality assurance policies to support accurate results and provide strong customer service.
Technical Training: Provide technical consultation and training for new laboratory personnel, public health partners, students, and clinical microbiology laboratories to strengthen understanding of virology testing and surveillance.
Test Referral: Prepare, package, and ship referral tests to ensure all outsourced testing is completed appropriately.
Customer Service: Provide telephone-based customer service to submitting agencies by delivering timely laboratory results and status updates that support diagnosis, treatment, and control decisions.
Technical Guidance: Provide technical guidance to submitting agencies on specimen collection and laboratory testing procedures to promote proper practices within facilities and local laboratories.
Professional Development: Engage in educational activities such as literature review and conference attendance, and share acquired knowledge with colleagues to maintain current technical expertise while adhering to all laboratory safety policies.